Sedative Adverse ReactionNCT04226443
The Use of Midazolam and Remifentanil During Dialysis Access Procedures
A study testing Midazolam intravenous injection and Remifentanil intravenous bolus dose in people with Sedative Adverse Reaction and Analgesic Adverse Reaction, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
Trial summary
BACKGROUND: Sedation and analgesia are related to unexpected adverse events in chronic renal failure patients undergoing arteriovenous fistula placement procedures under monitored anesthesia care (MAC). Read more about this study
- Who is it for?
- Ages 43 to 81 years
- Conditions the study is for
- Sedative Adverse Reaction, Analgesic Adverse Reaction, Midazolam Adverse Reaction
- What is being tested?
- Midazolam intravenous injection and Remifentanil intravenous bolus dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2012to 30 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Forty-three to eighty-one years of age,
- ASA status: American Society of Anesthesiologist (ASA) status I-III,
- The diagnosis: A diagnosis of chronic renal failure,
- The operation type: An arteriovenous fistula procedure
Who cannot join
- Body mass index greater than 40 that are considered morbidly obese patients,
- Lung disorders leading to severe respiratory insufficiency such as; severe asthma, chronic obstructive lung disease,
- Severe cardiovascular insufficiency or dysfunction,
- Insulin-dependent diabetes mellitus,
- Severe hepatic diseases,
- ASA status of 4 and 5,
Show all 10Show fewer
- Neurologic disorders such as; the presence of epilepsy, arterial aneurysm, intracranial mass,
- Patients complaining about intense pain before the procedure and patients with a history of long term opioid use or chronic pain,
- Patients with a history of allergy to the study drugs,
- Patients without written informed consent.
About this study
Official title: The Use of Midazolam and Remifentanil During Arteriovenous Fistula Placement Procedure and Monitored Anesthesia Care
BACKGROUND: Sedation and analgesia are related to unexpected adverse events in chronic renal failure patients undergoing arteriovenous fistula placement procedures under monitored anesthesia care (MAC).
OBJECTIVE: Our goal was to investigate and compare the sedation and analgesia related effects and adverse effects of continuous intravenous use of midazolam and intermittent bolus doses of midazolam while intravenous remifentanil is used as a rescue medication in patients with chronic renal failure.
Read the detailed description
BACKGROUND: Sedation and analgesia are related to unexpected adverse events in chronic renal failure patients undergoing arteriovenous fistula placement procedures under monitored anesthesia care (MAC).
OBJECTIVE: Our goal was to investigate and compare the sedation and analgesia related effects and adverse effects of continuous intravenous use of midazolam to intermittent bolus doses of midazolam while intravenous remifentanil is used as a rescue medication in patients with chronic renal failure.
DESIGN: From a total of 116 patients, 99 patients with chronic renal failure undergoing arteriovenous fistula procedures were included in a prospective randomized study.
SETTINGS: Two tertiary care hospitals. PATIENTS: The patients were divided into Group 1 (continuous)(n=50); patients receiving intravenous midazolam infusion at a dose of 0.02 to 0.04 mg/kg/h and Group 2 (intermittent)(n=49); patients receiving intermittent intravenous bolus doses of 0.015 mg/kg every 10 minutes.
MAIN OUTCOME MEASURES: Primary outcomes were; 1- The total amount of doses of the use of midazolam and remifentanil in both groups of patients, 2- The evaluation of satisfaction of patient and surgeon at the end of the operation, in the recovery room during the period of recovery from sedation and before discharge. Other outcome measures include; the sedative, analgesic and hemodynamical effects of sedative medications that were compared in both groups of patients during the operation time period. The hospital stay duration was recorded and compared between groups. The maximum dose of midazolam was limited to 4 mg intravenously. The intensity of pain was assessed using a verbal numerical sedation scale (range 1 to 10) (VNRS) and the sedation level was recorded by Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) (range 0 to 6). MOSS/A Scale includes; Score 0: Does not respond to deep stimulus, Score 1: Does not respond to mild prodding or shaking, Score 2: Responds only after mild prodding or shaking, Score 3: Responds only after name is called loudly and/or repeatedly, Score 4: Lethargic response to name spoken in normal tone, Score 5: Responds readily to name spoken in normal tone, Score 6: Agitated. An intravenous bolus dose of remifentanil as a rescue medication was administered for pain scores greater than 3 at a dose of 5µg/mL. Adverse events were recorded. Patient satisfaction level depending on the experience in general were evaluated at discharge from 0 to 4 point numerical scale: 0 = extremely dissatisfied; 1 = dissatisfied; 2 = neither satisfied nor dissatisfied; 3 = satisfied; 4 = extremely satisfied. Surgeon satisfaction level depending on the experience in general were evaluated at discharge from five-point numerical scale: 0 = extremely poor; 1 = poor; 2 = fair; 3 = good; 4 = excellent.
SAMPLE SIZE: The sample size was calculated based on a power of 80% and a 5% type-I error and for each group, thirty patients were required.
- Conditions
- Sedative Adverse Reaction, Analgesic Adverse Reaction, Midazolam Adverse Reaction, Adverse Reaction to Drug, Patient Satisfaction, Chronic Kidney Diseases
- Being tested
- Midazolam intravenous injection, Remifentanil intravenous bolus dose
- Keywords
- Midazolam, Remifentanil, Benzodiazepine, Opioid, Chronic Kidney Diseases, Analgesia, Sedation, Adverse Reaction, Patient Satisfaction, Arteriovenous Fistula
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Patient Satisfaction, Renal Insufficiency, Chronic, Arteriovenous Fistula, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam intravenous injectionDrug
Also called Dormicum, Deva Pharmaceutical, Turkey
The midazolam was prepared as 5 mg midazolam in 20 mL syringe of 5% dextrose water solution (0.25 mg/mL) in both arms. Both groups of patients received an intravenous bolus dose of midazolam was administered before the start of the surgery. In Group 1, continuous infusion of intravenous midazolam was started and in Group 2, intravenous bolus doses of midazolam were administered. The doses were adjusted depending on pain level and sedation level using appropriate scales for monitoring during the surgical time period. The drip rate was adjusted according to pain intensity. The infusion of drugs was discontinued at the end of the procedure.
Remifentanil intravenous bolus doseDrug
Also called Ultiva, Glaxo Smith Kline Pharmaceutical, England
A remifentanil infusion was prepared as follows; 0.5 mg remifentanil was added into 100 mL of 0.9% saline at a concentration of 5 μg/mL. The preparation of remifentanil solution and installation of the device was done by an anesthesiologist who was blinded for the study groups. The dose and number of patients that required remifentanil were recorded. The infusion of drugs was discontinued at the end of the procedure. A rescue medication of intravenous remifentanil bolus dose was used as 1 to 3 mL (5 μg or 15 μg) every 5 minutes if necessary for pain scores greater than 3. This infusion was prepared prior to the use during the study and was discontinued at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | In Group 1(n=50); continuous infusion of intravenous midazolam (Dormicum, Deva Pharmaceutical, Turkey) at a dose of 0.02 to 0.04 mg/kg/h was started at the beginning of the operation and the dose was adjusted depending on pain level and sedation level using appropriate scales for monitoring throughout the surgical time period. An intravenous bolus dose of midazolam at a dose of 0.015 mg/kg was administered before the start of the surgery. A rescue medication of intravenous bolus dose of remifentanil at a concentration of 5 μg/mL was used every 5 to 10 minutes in doses of 1 to 3 mL if necessary for pain scores greater than 3. The medications were stopped prior to the end of the surgery. Receives: Drug: Midazolam intravenous injection; Drug: Remifentanil intravenous bolus dose |
| Group 2 | Active comparator | in Group 2 (n=49), intravenous bolus doses of midazolam at a dose of 0.015 mg/kg every 10 minutes were administered at the beginning of the operation and the dose was adjusted depending on pain level and sedation level using appropriate scales for monitoring throughout the surgical time period. An intravenous bolus dose of midazolam at a dose of 0.015 mg/kg was administered before the start of the surgery. A rescue medication of intravenous bolus dose of remifentanil at a concentration of 5 μg/mL was used every 5 to 10 minutes in doses of 1 to 3 mL if necessary for pain scores greater than 3. The medications were stopped prior to the end of the surgery. Receives: Drug: Midazolam intravenous injection; Drug: Remifentanil intravenous bolus dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period.
The comparison of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period between the two groups.
Measured: Through the operative time period up to two hours of time.
The evaluation of satisfaction of patient and surgeon by a questionnaire at the end of operation.
The evaluation and comparison of satisfaction of patient and surgeon at the end of operation by a questionnaire between the two groups. Patient satisfaction level depending on the experience in general was evaluated at discharge from 0 to 4 point numerical scale: 0 = extremely dissatisfied; 1 = dissatisfied; 2 = neither satisfied nor dissatisfied; 3 = satisfied; 4 = extremely satisfied. Surgeon satisfaction level depending on the experience in general was evaluated at discharge from five point numerical scale: 0 = extremely poor; 1 = poor; 2 = fair; 3 = good; 4 = excellent.
Measured: The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time.
Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale
The comparison of level of sedation using MOSS/A scale that ranges from 0 to 6, with a score of 6 defined as awake or minimally sedated, and a score of 0 defined as general anesthesia every 10 to 15 minutes between the two groups.
Measured: Through the operative time period up to two hours of time.
Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale
Repeated measure analysis of level of sedation by the use of the collected MOSS/A scale that ranges from 0 to 6, with a score of 6 defined as awake or minimally sedated, and a score of 0 defined as general anesthesia every 10 to 15 minutes within groups.
Measured: Through the operative time period up to two hours of time.
Verbal Numerical Rating Scale
The comparison of level of pain using Verbal Numerical Rating Scale (VNRS; 0= no pain, 10=the worst possible pain imaginable) scale every 10 to 15 minutes between the two groups.
Measured: Through the operative time period up to two hours of time.
Verbal Numerical Rating Scale
Repeated measure analysis of level of sedation by the use of the collected Verbal Numerical Rating Scale (VNRS; 0= no pain, 10=the worst possible pain imaginable) scale every 10 to 15 minutes between the two groups.
Measured: Through the operative time period up to two hours of time.
Recovery time
The comparison of recovery time duration presented in minutes unit of time between the two groups.
Measured: Through the recovery room time period before discharge up to one hour time.
Hospital stay
The comparison of hospital stay duration presented in hours unit of time between the two groups.
Measured: Through the duration of stay in hospital before discharge up to seventy two hours time.
Systolic blood pressure values during operation and in the recovery room.
The comparison of systolic blood pressure in mmHg unit values every 15 minutes between the two groups.
Measured: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
Heart rate values during operation and in the recovery room.
The comparison of heart rate values in beats per minute unit every fifteen minutes between the two groups.
Measured: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
Pulse oximetry values during operation and in the recovery room.
The comparison of pulse oximetry values in percent unit every fifteen minutes between the two groups.
Measured: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
Adverse events during operation and in the recovery room.
Number of Participants With Adverse Events as Assessed by CTCAE Version 4.03.
Measured: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start28 Aug 2012
- Primary completion15 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sedative Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized clinical study. The patients were divided into two groups with a 1: 1 allocation and sealed envelope randomization method. Both groups of patients received intravenous midazolam, in Group 1, intravenous midazolam was administered continuously whereas, in Group 2, intravenous midazolam was administered as intermittent bolus doses. Both groups received intravenous remifentanil bolus doses as a rescue medication.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Trakya University
- Responsible party
- Principal investigator, Ayse Baysal, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Investigators
- Gonul Sagiroglu, MD, Study director, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226443
- Sponsor's protocol ID
- 2013.1/28(#)
- Status last verified
- Jan 2020
- First submitted
- 28 Nov 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is a prospective, randomized clinical study. Both groups of patients received intravenous midazolam in two different methods. The groups were assigned depending on the use of intravenous midazolam as a continuous infusion or intermittent bolus doses. In both groups, as a rescue medication, intravenous bolus doses of remifentanil was used. The titration of the doses of midazolam and remifentanil was done according to the use of pain intensity level and the sedation level evaluations. The primary outcome was the comparison of the total amount of doses of the use of midazolam and remifentanil in milligrams in both groups of patients and the comparison of the satisfaction of patients and surgeons using an appropriate questionnaire. The pain intensity and sedation level, hemodynamical effects, as well as adverse events, were compared in both groups of patients. The recovery time and hospital stay duration were compared between the two groups of patients.
Publications
Cole NM, Vlassakov K, Brovman EY, Heydarpour M, Urman RD. Regional Anesthesia for Arteriovenous Fistula Surgery May Reduce Hospital Length of Stay and Reoperation Rates. Vasc Endovascular Surg. 2018 Aug;52(6):418-426. doi: 10.1177/1538574418772451. Epub 2018 Apr 29.
PubMed 29706126Sa Rego MM, Inagaki Y, White PF. Remifentanil administration during monitored anesthesia care: are intermittent boluses an effective alternative to a continuous infusion? Anesth Analg. 1999 Mar;88(3):518-22. doi: 10.1097/00000539-199903000-00009.
PubMed 10071997Sun GQ, Gao BF, Li GJ, Lei YL, Li J. Application of remifentanil for conscious sedation and analgesia in short-term ERCP and EST surgery. Medicine (Baltimore). 2017 Apr;96(16):e6567. doi: 10.1097/MD.0000000000006567.
PubMed 28422846Wyne A, Rai R, Cuerden M, Clark WF, Suri RS. Opioid and benzodiazepine use in end-stage renal disease: a systematic review. Clin J Am Soc Nephrol. 2011 Feb;6(2):326-33. doi: 10.2215/CJN.04770610. Epub 2010 Nov 11.
PubMed 21071517Ahuja V, Mitra S, Kazal S, Huria A. Comparison of analgesic efficacy of flupirtine maleate and ibuprofen in gynaecological ambulatory surgeries: A randomized controlled trial. Indian J Anaesth. 2015 Jul;59(7):411-5. doi: 10.4103/0019-5049.160937.
PubMed 26257413Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.
PubMed 15882252Boonstra AM, Stewart RE, Koke AJ, Oosterwijk RF, Swaan JL, Schreurs KM, Schiphorst Preuper HR. Cut-Off Points for Mild, Moderate, and Severe Pain on the Numeric Rating Scale for Pain in Patients with Chronic Musculoskeletal Pain: Variability and Influence of Sex and Catastrophizing. Front Psychol. 2016 Sep 30;7:1466. doi: 10.3389/fpsyg.2016.01466. eCollection 2016.
PubMed 27746750Beathard GA, Urbanes A, Litchfield T, Weinstein A. The risk of sedation/analgesia in hemodialysis patients undergoing interventional procedures. Semin Dial. 2011 Jan-Feb;24(1):97-103. doi: 10.1111/j.1525-139X.2011.00844.x.
PubMed 21338400Son A, Mannoia K, Herrera A, Chizari M, Hagdoost M, Molkara A. Dialysis Access Surgery: Does Anesthesia Type Affect Maturation and Complication Rates? Ann Vasc Surg. 2016 May;33:116-9. doi: 10.1016/j.avsg.2015.12.005. Epub 2016 Mar 8.
PubMed 26965819Niscola P, Scaramucci L, Vischini G, Giovannini M, Ferrannini M, Massa P, Tatangelo P, Galletti M, Palumbo R. The use of major analgesics in patients with renal dysfunction. Curr Drug Targets. 2010 Jun;11(6):752-8. doi: 10.2174/138945010791170879.
PubMed 20041843Hatzidakis AA, Charonitakis E, Athanasiou A, Tsetis D, Chlouverakis G, Papamastorakis G, Roussopoulou G, Gourtsoyiannis NC. Sedations and analgesia in patients undergoing percutaneous transhepatic biliary drainage. Clin Radiol. 2003 Feb;58(2):121-7. doi: 10.1053/crad.2002.1128.
PubMed 12623040Coyle TT, Helfrick JF, Gonzalez ML, Andresen RV, Perrott DH. Office-based ambulatory anesthesia: Factors that influence patient satisfaction or dissatisfaction with deep sedation/general anesthesia. J Oral Maxillofac Surg. 2005 Feb;63(2):163-72. doi: 10.1016/j.joms.2004.10.003.
PubMed 15690283
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Midazolam and Remifentanil During Arteriovenous Fistula Placement Procedure and Monitored Anesthesia Care
- ClinicalTrials.gov ID
- NCT04226443
- Acronym / sponsor ID
- 2013.1/28(#)
- Conditions
- Sedative Adverse Reaction, Analgesic Adverse Reaction, Midazolam Adverse Reaction, Adverse Reaction to Drug, Patient Satisfaction, Chronic Kidney Diseases
- Keywords
- Midazolam, Remifentanil, Benzodiazepine, Opioid, Chronic Kidney Diseases, Analgesia, Sedation, Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Collaborators
- Trakya University
- Study start
- 28 Aug 2012 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Sedation and analgesia are related to unexpected adverse events in chronic renal failure patients undergoing arteriovenous fistula placement procedures under monitored anesthesia care (MAC).
OBJECTIVE: Our goal was to investigate and compare the sedation and analgesia related effects and adverse effects of continuous intravenous use of midazolam and intermittent bolus doses of midazolam while intravenous remifentanil is used as a rescue medication in patients with chronic renal failure.
Detailed description
BACKGROUND: Sedation and analgesia are related to unexpected adverse events in chronic renal failure patients undergoing arteriovenous fistula placement procedures under monitored anesthesia care (MAC).
OBJECTIVE: Our goal was to investigate and compare the sedation and analgesia related effects and adverse effects of continuous intravenous use of midazolam to intermittent bolus doses of midazolam while intravenous remifentanil is used as a rescue medication in patients with chronic renal failure.
DESIGN: From a total of 116 patients, 99 patients with chronic renal failure undergoing arteriovenous fistula procedures were included in a prospective randomized study.
SETTINGS: Two tertiary care hospitals. PATIENTS: The patients were divided into Group 1 (continuous)(n=50); patients receiving intravenous midazolam infusion at a dose of 0.02 to 0.04 mg/kg/h and Group 2 (intermittent)(n=49); patients receiving intermittent intravenous bolus doses of 0.015 mg/kg every 10 minutes.
MAIN OUTCOME MEASURES: Primary outcomes were; 1- The total amount of doses of the use of midazolam and remifentanil in both groups of patients, 2- The evaluation of satisfaction of patient and surgeon at the end of the operation, in the recovery room during the period of recovery from sedation and before discharge. Other outcome measures include; the sedative, analgesic and hemodynamical effects of sedative medications that were compared in both groups of patients during the operation time period. The hospital stay duration was recorded and compared between groups. The maximum dose of midazolam was limited to 4 mg intravenously. The intensity of pain was assessed using a verbal numerical sedation scale (range 1 to 10) (VNRS) and the sedation level was recorded by Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) (range 0 to 6). MOSS/A Scale includes; Score 0: Does not respond to deep stimulus, Score 1: Does not respond to mild prodding or shaking, Score 2: Responds only after mild prodding or shaking, Score 3: Responds only after name is called loudly and/or repeatedly, Score 4: Lethargic response to name spoken in normal tone, Score 5: Responds readily to name spoken in normal tone, Score 6: Agitated. An intravenous bolus dose of remifentanil as a rescue medication was administered for pain scores greater than 3 at a dose of 5µg/mL. Adverse events were recorded. Patient satisfaction level depending on the experience in general were evaluated at discharge from 0 to 4 point numerical scale: 0 = extremely dissatisfied; 1 = dissatisfied; 2 = neither satisfied nor dissatisfied; 3 = satisfied; 4 = extremely satisfied. Surgeon satisfaction level depending on the experience in general were evaluated at discharge from five-point numerical scale: 0 = extremely poor; 1 = poor; 2 = fair; 3 = good; 4 = excellent.
SAMPLE SIZE: The sample size was calculated based on a power of 80% and a 5% type-I error and for each group, thirty patients were required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This is a prospective, randomized clinical study. The patients were divided into two groups with a 1: 1 allocation and sealed envelope randomization method. Both groups of patients received intravenous midazolam, in Group 1, intravenous midazolam was administered continuously whereas, in Group 2, intravenous midazolam was administered as intermittent bolus doses. Both groups received intravenous remifentanil bolus doses as a rescue medication.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Midazolam intravenous injection, Drug: Remifentanil intravenous bolus doseIn Group 1(n=50); continuous infusion of intravenous midazolam (Dormicum, Deva Pharmaceutical, Turkey) at a dose of 0.02 to 0.04 mg/kg/h was started at the beginning of the operation and the dose was adjusted depending on pain level and sedation level using appropriate scales for monitoring throughout the surgical time period. An intravenous bolus dose of midazolam at a dose of 0.015 mg/kg was administered before the start of the surgery. A rescue medication of intravenous bolus dose of remifentanil at a concentration of 5 μg/mL was used every 5 to 10 minutes in doses of 1 to 3 mL if necessary for pain scores greater than 3. The medications were stopped prior to the end of the surgery. |
| Group 2 | Active comparator | Drug: Midazolam intravenous injection, Drug: Remifentanil intravenous bolus dosein Group 2 (n=49), intravenous bolus doses of midazolam at a dose of 0.015 mg/kg every 10 minutes were administered at the beginning of the operation and the dose was adjusted depending on pain level and sedation level using appropriate scales for monitoring throughout the surgical time period. An intravenous bolus dose of midazolam at a dose of 0.015 mg/kg was administered before the start of the surgery. A rescue medication of intravenous bolus dose of remifentanil at a concentration of 5 μg/mL was used every 5 to 10 minutes in doses of 1 to 3 mL if necessary for pain scores greater than 3. The medications were stopped prior to the end of the surgery. |
Who may qualify
- Ages
- 43 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: Forty-three to eighty-one years of age,
- ASA status: American Society of Anesthesiologist (ASA) status I-III,
- The diagnosis: A diagnosis of chronic renal failure,
- The operation type: An arteriovenous fistula procedure
Key exclusion criteria (10 listed)
- Body mass index greater than 40 that are considered morbidly obese patients,
- Lung disorders leading to severe respiratory insufficiency such as; severe asthma, chronic obstructive lung disease,
- Severe cardiovascular insufficiency or dysfunction,
- Insulin-dependent diabetes mellitus,
- Severe hepatic diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam intravenous injectionAlso: Dormicum, Deva Pharmaceutical, TurkeyThe midazolam was prepared as 5 mg midazolam in 20 mL syringe of 5% dextrose water solution (0.25 mg/mL) in both arms. Both groups of patients received an intravenous bolus dose of midazolam was administered before the start of the surgery. In Group 1, continuous infusion of intravenous midazolam was started and in Group 2, intravenous bolus doses of midazolam were administered. The doses were adjusted depending on pain level and sedation level using appropriate scales for monitoring during the surgical time period. The drip rate was adjusted according to pain intensity. The infusion of drugs was discontinued at the end of the procedure. | Drug | Group 1, Group 2 |
| Remifentanil intravenous bolus doseAlso: Ultiva, Glaxo Smith Kline Pharmaceutical, EnglandA remifentanil infusion was prepared as follows; 0.5 mg remifentanil was added into 100 mL of 0.9% saline at a concentration of 5 μg/mL. The preparation of remifentanil solution and installation of the device was done by an anesthesiologist who was blinded for the study groups. The dose and number of patients that required remifentanil were recorded. The infusion of drugs was discontinued at the end of the procedure. A rescue medication of intravenous remifentanil bolus dose was used as 1 to 3 mL (5 μg or 15 μg) every 5 minutes if necessary for pain scores greater than 3. This infusion was prepared prior to the use during the study and was discontinued at the end of the procedure. | Drug | Group 1, Group 2 |
Primary outcome
The amount of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period.
Time frame: Through the operative time period up to two hours of time.
The comparison of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period between the two groups.
The evaluation of satisfaction of patient and surgeon by a questionnaire at the end of operation.
Time frame: The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time.
The evaluation and comparison of satisfaction of patient and surgeon at the end of operation by a questionnaire between the two groups. Patient satisfaction level depending on the experience in general was evaluated at discharge from 0 to 4 point numerical scale: 0 = extremely dissatisfied; 1 = dissatisfied; 2 = neither satisfied nor dissatisfied; 3 = satisfied; 4 = extremely satisfied. Surgeon satisfaction level depending on the experience in general was evaluated at discharge from five point numerical scale: 0 = extremely poor; 1 = poor; 2 = fair; 3 = good; 4 = excellent.
Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale
Time frame: Through the operative time period up to two hours of time.
The comparison of level of sedation using MOSS/A scale that ranges from 0 to 6, with a score of 6 defined as awake or minimally sedated, and a score of 0 defined as general anesthesia every 10 to 15 minutes between the two groups.
Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale
Time frame: Through the operative time period up to two hours of time.
Repeated measure analysis of level of sedation by the use of the collected MOSS/A scale that ranges from 0 to 6, with a score of 6 defined as awake or minimally sedated, and a score of 0 defined as general anesthesia every 10 to 15 minutes within groups.
Verbal Numerical Rating Scale
Time frame: Through the operative time period up to two hours of time.
The comparison of level of pain using Verbal Numerical Rating Scale (VNRS; 0= no pain, 10=the worst possible pain imaginable) scale every 10 to 15 minutes between the two groups.
Verbal Numerical Rating Scale
Time frame: Through the operative time period up to two hours of time.
Repeated measure analysis of level of sedation by the use of the collected Verbal Numerical Rating Scale (VNRS; 0= no pain, 10=the worst possible pain imaginable) scale every 10 to 15 minutes between the two groups.
Recovery time
Time frame: Through the recovery room time period before discharge up to one hour time.
The comparison of recovery time duration presented in minutes unit of time between the two groups.
Hospital stay
Time frame: Through the duration of stay in hospital before discharge up to seventy two hours time.
The comparison of hospital stay duration presented in hours unit of time between the two groups.
Systolic blood pressure values during operation and in the recovery room.
Time frame: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
The comparison of systolic blood pressure in mmHg unit values every 15 minutes between the two groups.
Heart rate values during operation and in the recovery room.
Time frame: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
The comparison of heart rate values in beats per minute unit every fifteen minutes between the two groups.
Pulse oximetry values during operation and in the recovery room.
Time frame: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
The comparison of pulse oximetry values in percent unit every fifteen minutes between the two groups.
Adverse events during operation and in the recovery room.
Time frame: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
Number of Participants With Adverse Events as Assessed by CTCAE Version 4.03.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 29706126Cole NM, Vlassakov K, Brovman EY, Heydarpour M, Urman RD. Regional Anesthesia for Arteriovenous Fistula Surgery May Reduce Hospital Length of Stay and Reoperation Rates. Vasc Endovascular Surg. 2018 Aug;52(6):418-426. doi: 10.1177/1538574418772451. Epub 2018 Apr 29.
- Background: PubMed 10071997Sa Rego MM, Inagaki Y, White PF. Remifentanil administration during monitored anesthesia care: are intermittent boluses an effective alternative to a continuous infusion? Anesth Analg. 1999 Mar;88(3):518-22. doi: 10.1097/00000539-199903000-00009.
- Background: PubMed 28422846Sun GQ, Gao BF, Li GJ, Lei YL, Li J. Application of remifentanil for conscious sedation and analgesia in short-term ERCP and EST surgery. Medicine (Baltimore). 2017 Apr;96(16):e6567. doi: 10.1097/MD.0000000000006567.
- Background: PubMed 21071517Wyne A, Rai R, Cuerden M, Clark WF, Suri RS. Opioid and benzodiazepine use in end-stage renal disease: a systematic review. Clin J Am Soc Nephrol. 2011 Feb;6(2):326-33. doi: 10.2215/CJN.04770610. Epub 2010 Nov 11.
- Background: PubMed 26257413Ahuja V, Mitra S, Kazal S, Huria A. Comparison of analgesic efficacy of flupirtine maleate and ibuprofen in gynaecological ambulatory surgeries: A randomized controlled trial. Indian J Anaesth. 2015 Jul;59(7):411-5. doi: 10.4103/0019-5049.160937.
- Background: PubMed 15882252Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.
- Results publication: PubMed 27746750Boonstra AM, Stewart RE, Koke AJ, Oosterwijk RF, Swaan JL, Schreurs KM, Schiphorst Preuper HR. Cut-Off Points for Mild, Moderate, and Severe Pain on the Numeric Rating Scale for Pain in Patients with Chronic Musculoskeletal Pain: Variability and Influence of Sex and Catastrophizing. Front Psychol. 2016 Sep 30;7:1466. doi: 10.3389/fpsyg.2016.01466. eCollection 2016.
- Results publication: PubMed 21338400Beathard GA, Urbanes A, Litchfield T, Weinstein A. The risk of sedation/analgesia in hemodialysis patients undergoing interventional procedures. Semin Dial. 2011 Jan-Feb;24(1):97-103. doi: 10.1111/j.1525-139X.2011.00844.x.
- Results publication: PubMed 26965819Son A, Mannoia K, Herrera A, Chizari M, Hagdoost M, Molkara A. Dialysis Access Surgery: Does Anesthesia Type Affect Maturation and Complication Rates? Ann Vasc Surg. 2016 May;33:116-9. doi: 10.1016/j.avsg.2015.12.005. Epub 2016 Mar 8.
- Results publication: PubMed 20041843Niscola P, Scaramucci L, Vischini G, Giovannini M, Ferrannini M, Massa P, Tatangelo P, Galletti M, Palumbo R. The use of major analgesics in patients with renal dysfunction. Curr Drug Targets. 2010 Jun;11(6):752-8. doi: 10.2174/138945010791170879.
- Results publication: PubMed 12623040Hatzidakis AA, Charonitakis E, Athanasiou A, Tsetis D, Chlouverakis G, Papamastorakis G, Roussopoulou G, Gourtsoyiannis NC. Sedations and analgesia in patients undergoing percutaneous transhepatic biliary drainage. Clin Radiol. 2003 Feb;58(2):121-7. doi: 10.1053/crad.2002.1128.
- Results publication: PubMed 15690283Coyle TT, Helfrick JF, Gonzalez ML, Andresen RV, Perrott DH. Office-based ambulatory anesthesia: Factors that influence patient satisfaction or dissatisfaction with deep sedation/general anesthesia. J Oral Maxillofac Surg. 2005 Feb;63(2):163-72. doi: 10.1016/j.joms.2004.10.003.
- Individual participant dataSharing planned: Yes. This is a prospective, randomized clinical study. Both groups of patients received intravenous midazolam in two different methods. The groups were assigned depending on the use of intravenous midazolam as a continuous infusion or intermittent bolus doses. In both groups, as a rescue medication, intravenous bolus doses of remifentanil was used. The titration of the doses of midazolam and remifentanil was done according to the use of pain intensity level and the sedation level evaluations. The primary outcome was the comparison of the total amount of doses of the use of midazolam and remifentanil in milligrams in both groups of patients and the comparison of the satisfaction of patients and surgeons using an appropriate questionnaire. The pain intensity and sedation level, hemodynamical effects, as well as adverse events, were compared in both groups of patients. The recovery time and hospital stay duration were compared between the two groups of patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonul Sagiroglu, MD study director
Trakya University
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam intravenous injection and Remifentanil intravenous bolus dose in people with Sedative Adverse Reaction and Analgesic Adverse Reaction, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period. (time frame: Through the operative time period up to two hours of time.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04226443, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.