Opioid Use, UnspecifiedNCT04749069
Anesthesia for Vascular Access Devices
A study testing Comparison of pain intensity rating scale in people with Opioid Use, Unspecified and Remifentanil, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Our aim was to investigate whether remifentanil use in both infusion and bolus techniques could provide sufficient sedation and analgesia without serious adverse effects for central venous access device procedures under monitored anesthesia care. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Opioid Use, Unspecified, Remifentanil, Sedation Complication
- What is being tested?
- Comparison of pain intensity rating scale
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2012to 30 Jun 2020
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-80 years old,
- American Society of Anesthesiologists Physical Status I to III,
- Referred for an venous access device implantation or removal procedure.
Who cannot join
- morbid obesity (body mass index > 40),
- severe asthma, chronic obstructive lung disease, diabetes mellitus, hepatorenal disease,
- a history of opioid allergy,
- long-term opioid use or chronic pain,
- ASA PS ≥ 4,
- presence of epilepsy,
Show all 9Show fewer
- acute cerebrovascular event,
- presence of hemodynamical instability such as peripheral oxygen saturation < 90%, systolic blood pressure < 60 mmHg and heart rate ≤ 40 bpm,
- patients complaining about intense pain before the procedure.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Trakya University Faculty of Medicine Department of Anesthesiology
Edirne, 22030
Kartal Kosuyolu High Speciality Training and Research Hospital
Istanbul, 34846
About this study
Official title: The Comparison of Two Different Techniques of Remifentanil Consumption During Implantable Vascular Access Device Procedures
Our aim was to investigate whether remifentanil use in both infusion and bolus techniques could provide sufficient sedation and analgesia without serious adverse effects for central venous access device procedures under monitored anesthesia care.
Read the detailed description
The insertion and removal of implantable venous access devices (port-a-cath type) requires moderate level of sedation and monitored anesthesia care to prevent pain and anxiety of patients during the procedure. According to the American Society of Anesthesiologist Physical Status Score, monitored anesthesia care is a planned procedure where a patient undergoes local anesthetic infiltration together with sedation and analgesia. Remifentanil is a potent synthetic opioid with novel pharmacokinetic properties, including very rapid onset and an ultra short duration of action, making it effective for pain relief in short procedures. Remifentanil can be administered as either one of the techniques of intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA).In previous studies, the insertion or removal of venous access procedures required either local anesthesia or low doses of orally administered anxiolytic medication. The infusion of remifentanil may cause respiratory depression and analgesic efficacy and safety of administration of remifentanil infusion and/or bolus doses of remifentanil during the administration of one of the techniques of either CI or PCSA in short term procedures has not been well studied. The prospective trials that compare analgesic efficacy and adverse events related to intravenous remifentanil consumption in sedation and analgesia of short procedures are very limited.
This study aims to compare level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, patient and surgeon satisfaction, hemodynamic data and adverse events of two different techniques of intravenous remifentanil use such as; intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA) in patients under moderate level of sedation for vascular access procedures.
- Conditions
- Opioid Use, Unspecified, Remifentanil, Sedation Complication, Analgesia, Satisfaction, Patient, Vascular Access Complication
- Being tested
- Comparison of pain intensity rating scale
- Medical subject headings
- Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of pain intensity rating scaleDiagnostic test
Also called Sedation-Numerical pain intensity rating scale, Faces pain rating scale, Analgesia-Ramsey sedation scale, Drug-Remifentanil consumption of total amount of remifentanil
Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion of remifentanil | Experimental | In continuous infusion group of patients, remifentanil was infused at a dose of 0.1 µg/kg/min and the additional bolus dose of 0.1 µg/kg was given if required. Before start of the operation, in both groups of patients, intravenous remifentanil at a bolus dose of 0.1 µg/kg was administered slowly in a duration of 60 seconds. Receives: Diagnostic Test: Comparison of pain intensity rating scale |
| Patient-controlled sedoanalgesia (PCSA) of remifentanil | Experimental | In PCSA group of patients, remifentanil was given by bolus PCSA using a pump (Pain Management Provider, Abbott Laboratories and Eczacibasi-Baxter, Ireland). In PCSA group of patients, remifentanil infusion was at a dose of 0.05 µg/kg, a bolus dose of 0.1 μg/kg with a lock-out time of three minutes. Receives: Diagnostic Test: Comparison of pain intensity rating scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numeric Pain Intensity Rating Scale (NPRS)
During NPRS pain evaluation, a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain comparison and this includes 0 as no pain and 10 as the worst pain imaginable. There is a comparison of pain scale scores as a decrease of pain relief in an amount of 30% from the pain at start between the two groups.
Measured: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
The faces pain rating scale
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
Measured: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
Measurement of sedation and analgesia
The comparison of the use of Ramsay Sedation Scale for measurement of sedation and analgesia between the two groups.The Ramsay Sedation Scale involves 6 levels and these include; 1- Patient is anxious and agitated or restless, or both, 2- Patient is co-operative, oriented, and tranquil, 3-Patient responds to commands only, 4- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5-Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6- Patient exhibits no response.
Measured: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
Secondary outcomes (11)
Total Remifentanil Consumption
The comparison of the use of total remifentanil consumption between the two groups.
Measured: At the end of operation, through the operative time period up to two hours of time.
Modified Aldrete Score
The comparison of the use of Modified Aldrete scores in the recovery room before discharge between the two groups.
Measured: Through the recovery room time period before discharge up to one hour time.
Duration of operation
The comparison of the duration of operations between the two groups.
Measured: At the end of operation, through the operative time period up to two hours of time.
Incidence of adverse events and side effects.
The comparison of the incidence of adverse events and side effects between the two groups.
Measured: After operation in the recovery room through the recovery room time period before discharge up to one hour time and 24 hour after surgery.
Patient and surgeon satisfaction
The comparison of satisfaction of patient and surgeon by a questionnaire at the end of operation between two groups.
Measured: The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time.
Recovery time
The comparison of recovery time between two groups.
Measured: Through the recovery room time period before discharge up to one hour time.
Systolic blood pressure values during operation and in the recovery room.
The comparison of systolic blood pressure values during operation and in the recovery room between two groups.
Measured: The collection of systolic blood pressure in mmHg unit values every 15 minutes 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
Diastolic blood pressure values during operation and in the recovery room.
The comparison of diastolic blood pressure values during operation and in the recovery room between two groups.
Measured: The collection of diastolic blood pressure in mmHg unit values every 15 minutes 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 during operation and in the recovery room between 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 during operation and in the recovery room between two groups.
Measured: hrough the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time
Hospital Stay
The comparison of hospital stay between two groups.
Measured: Through the duration of stay in hospital before discharge up to seventy two hours time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Aug 2012
- Primary completion30 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Opioid Use, UnspecifiedStudies 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, single-blinded randomized clinical study. The patients were divided into two groups with the method of one to one allocation and with the use of sealed envelope randomization.The first group was continuous infusion group (Group CI) and intravenous continuous remifentanil was infused after starting at a dosage of 0.1 µg/kg/min and the dose was raised incrementally up to 1µg/kg/min if required. The second group was intravenous bolus patient-controlled sedation analgesia (PCSA) and remifentanil infusion at a dose of 0.05 µg/kg, bolus of 0.1 μg/kg with lock-out time of three minutes was used. In both groups, a bolus dose of 0.1 µg/kg remifentanil was administered. The data evaluated include; level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, use of a rescue medication, patient and surgeon satisfaction, hemodynamic data and adverse events.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 107 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749069
- Sponsor's protocol ID
- 2012.3.35(#)
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Purpose: The aim was to compare analgesic efficacy and adverse effects of two different techniques of intravenous remifentanil consumption in patients undergoing vascular access device procedures with monitored anesthesia care. The data evaluated include; level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, patient and surgeon satisfaction, hemodynamic data and adverse events.
Publications
Honarmand A, Safavi M, Nemati K, Oghab P. The efficacy of different doses of Midazolam added to Lidocaine for upper extremity Bier block on the sensory and motor block characteristics and postoperative pain. J Res Pharm Pract. 2015 Jul-Sep;4(3):160-6. doi: 10.4103/2279-042X.162359.
PubMed 26312256Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
PubMed 28877145Ryu JH, So YM, Hwang JW, Do SH. Optimal target concentration of remifentanil during cataract surgery with monitored anesthesia care. J Clin Anesth. 2010 Nov;22(7):533-7. doi: 10.1016/j.jclinane.2010.02.007.
PubMed 21056810Sun 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 28422846Chang DH, Hiss S, Herich L, Becker I, Mammadov K, Franke M, Mpotsaris A, Kleinert R, Persigehl T, Maintz D, Bangard C. Implantation of venous access devices under local anesthesia: patients' satisfaction with oral lorazepam. Patient Prefer Adherence. 2015 Jul 7;9:943-9. doi: 10.2147/PPA.S80330. eCollection 2015.
PubMed 26185424Zanvettor A, Lederer W, Glodny B, Chemelli AP, Wiedermann FJ. Procedural sedation and analgesia for percutaneous trans-hepatic biliary drainage: Randomized clinical trial for comparison of two different concepts. Open Med (Wars). 2020 Aug 28;15(1):815-821. doi: 10.1515/med-2020-0220. eCollection 2020.
PubMed 33336039Fanti L, Agostoni M, Gemma M, Gambino G, Facciorusso A, Guslandi M, Torri G, Testoni PA. Remifentanil vs. meperidine for patient-controlled analgesia during colonoscopy: a randomized double-blind trial. Am J Gastroenterol. 2009 May;104(5):1119-24. doi: 10.1038/ajg.2009.53. Epub 2009 Mar 31.
PubMed 19337241Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8):691-695. doi: 10.1097/AJP.0000000000000725.
PubMed 31094935
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Two Different Techniques of Remifentanil Consumption During Implantable Vascular Access Device Procedures
- ClinicalTrials.gov ID
- NCT04749069
- Acronym / sponsor ID
- 2012.3.35(#)
- Conditions
- Opioid Use, Unspecified, Remifentanil, Sedation Complication, Analgesia, Satisfaction, Patient, Vascular Access Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Collaborators
- Trakya University
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Feb 2021 (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.
Our aim was to investigate whether remifentanil use in both infusion and bolus techniques could provide sufficient sedation and analgesia without serious adverse effects for central venous access device procedures under monitored anesthesia care.
Detailed description
The insertion and removal of implantable venous access devices (port-a-cath type) requires moderate level of sedation and monitored anesthesia care to prevent pain and anxiety of patients during the procedure. According to the American Society of Anesthesiologist Physical Status Score, monitored anesthesia care is a planned procedure where a patient undergoes local anesthetic infiltration together with sedation and analgesia. Remifentanil is a potent synthetic opioid with novel pharmacokinetic properties, including very rapid onset and an ultra short duration of action, making it effective for pain relief in short procedures. Remifentanil can be administered as either one of the techniques of intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA).In previous studies, the insertion or removal of venous access procedures required either local anesthesia or low doses of orally administered anxiolytic medication. The infusion of remifentanil may cause respiratory depression and analgesic efficacy and safety of administration of remifentanil infusion and/or bolus doses of remifentanil during the administration of one of the techniques of either CI or PCSA in short term procedures has not been well studied. The prospective trials that compare analgesic efficacy and adverse events related to intravenous remifentanil consumption in sedation and analgesia of short procedures are very limited.
This study aims to compare level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, patient and surgeon satisfaction, hemodynamic data and adverse events of two different techniques of intravenous remifentanil use such as; intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA) in patients under moderate level of sedation for vascular access procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-blinded randomized clinical study. The patients were divided into two groups with the method of one to one allocation and with the use of sealed envelope randomization.The first group was continuous infusion group (Group CI) and intravenous continuous remifentanil was infused after starting at a dosage of 0.1 µg/kg/min and the dose was raised incrementally up to 1µg/kg/min if required. The second group was intravenous bolus patient-controlled sedation analgesia (PCSA) and remifentanil infusion at a dose of 0.05 µg/kg, bolus of 0.1 μg/kg with lock-out time of three minutes was used. In both groups, a bolus dose of 0.1 µg/kg remifentanil was administered. The data evaluated include; level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, use of a rescue medication, patient and surgeon satisfaction, hemodynamic data and adverse events.
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion of remifentanil | Experimental | Diagnostic Test: Comparison of pain intensity rating scaleIn continuous infusion group of patients, remifentanil was infused at a dose of 0.1 µg/kg/min and the additional bolus dose of 0.1 µg/kg was given if required. Before start of the operation, in both groups of patients, intravenous remifentanil at a bolus dose of 0.1 µg/kg was administered slowly in a duration of 60 seconds. |
| Patient-controlled sedoanalgesia (PCSA) of remifentanil | Experimental | Diagnostic Test: Comparison of pain intensity rating scaleIn PCSA group of patients, remifentanil was given by bolus PCSA using a pump (Pain Management Provider, Abbott Laboratories and Eczacibasi-Baxter, Ireland). In PCSA group of patients, remifentanil infusion was at a dose of 0.05 µg/kg, a bolus dose of 0.1 μg/kg with a lock-out time of three minutes. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 30-80 years old,
- American Society of Anesthesiologists Physical Status I to III,
- Referred for an venous access device implantation or removal procedure.
Key exclusion criteria (9 listed)
- morbid obesity (body mass index > 40),
- severe asthma, chronic obstructive lung disease, diabetes mellitus, hepatorenal disease,
- a history of opioid allergy,
- long-term opioid use or chronic pain,
- ASA PS ≥ 4,
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 |
|---|---|---|
| Comparison of pain intensity rating scaleAlso: Sedation-Numerical pain intensity rating scale, Faces pain rating scale, Analgesia-Ramsey sedation scale, Drug-Remifentanil consumption of total amount of remifentanilComparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil | Diagnostic test | Continuous infusion of remifentanil, Patient-controlled sedoanalgesia (PCSA) of remifentanil |
Primary outcome
The Numeric Pain Intensity Rating Scale (NPRS)
Time frame: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
During NPRS pain evaluation, a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain comparison and this includes 0 as no pain and 10 as the worst pain imaginable. There is a comparison of pain scale scores as a decrease of pain relief in an amount of 30% from the pain at start between the two groups.
The faces pain rating scale
Time frame: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
Measurement of sedation and analgesia
Time frame: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
The comparison of the use of Ramsay Sedation Scale for measurement of sedation and analgesia between the two groups.The Ramsay Sedation Scale involves 6 levels and these include; 1- Patient is anxious and agitated or restless, or both, 2- Patient is co-operative, oriented, and tranquil, 3-Patient responds to commands only, 4- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5-Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6- Patient exhibits no response.
11 secondary outcomes
Total Remifentanil Consumption
Time frame: At the end of operation, through the operative time period up to two hours of time.
Modified Aldrete Score
Time frame: Through the recovery room time period before discharge up to one hour time.
Duration of operation
Time frame: At the end of operation, through the operative time period up to two hours of time.
Incidence of adverse events and side effects.
Time frame: After operation in the recovery room through the recovery room time period before discharge up to one hour time and 24 hour after surgery.
Patient and surgeon satisfaction
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.
Recovery time
Time frame: Through the recovery room time period before discharge up to one hour time.
Systolic blood pressure values during operation and in the recovery room.
Time frame: The collection of systolic blood pressure in mmHg unit values every 15 minutes 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
Diastolic blood pressure values during operation and in the recovery room.
Time frame: The collection of diastolic blood pressure in mmHg unit values every 15 minutes 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.
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.
Pulse oximetry values during operation and in the recovery room.
Time frame: hrough the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time
Hospital Stay
Time frame: Through the duration of stay in hospital before discharge up to seventy two hours time.
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 10 Feb 2021.
- Background: PubMed 26312256Honarmand A, Safavi M, Nemati K, Oghab P. The efficacy of different doses of Midazolam added to Lidocaine for upper extremity Bier block on the sensory and motor block characteristics and postoperative pain. J Res Pharm Pract. 2015 Jul-Sep;4(3):160-6. doi: 10.4103/2279-042X.162359.
- Background: PubMed 28877145Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
- Background: PubMed 21056810Ryu JH, So YM, Hwang JW, Do SH. Optimal target concentration of remifentanil during cataract surgery with monitored anesthesia care. J Clin Anesth. 2010 Nov;22(7):533-7. doi: 10.1016/j.jclinane.2010.02.007.
- Results publication: 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.
- Results publication: PubMed 26185424Chang DH, Hiss S, Herich L, Becker I, Mammadov K, Franke M, Mpotsaris A, Kleinert R, Persigehl T, Maintz D, Bangard C. Implantation of venous access devices under local anesthesia: patients' satisfaction with oral lorazepam. Patient Prefer Adherence. 2015 Jul 7;9:943-9. doi: 10.2147/PPA.S80330. eCollection 2015.
- Results publication: PubMed 33336039Zanvettor A, Lederer W, Glodny B, Chemelli AP, Wiedermann FJ. Procedural sedation and analgesia for percutaneous trans-hepatic biliary drainage: Randomized clinical trial for comparison of two different concepts. Open Med (Wars). 2020 Aug 28;15(1):815-821. doi: 10.1515/med-2020-0220. eCollection 2020.
- Results publication: PubMed 19337241Fanti L, Agostoni M, Gemma M, Gambino G, Facciorusso A, Guslandi M, Torri G, Testoni PA. Remifentanil vs. meperidine for patient-controlled analgesia during colonoscopy: a randomized double-blind trial. Am J Gastroenterol. 2009 May;104(5):1119-24. doi: 10.1038/ajg.2009.53. Epub 2009 Mar 31.
- Results publication: PubMed 31094935Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8):691-695. doi: 10.1097/AJP.0000000000000725.
- Individual participant dataSharing planned: Yes. Purpose: The aim was to compare analgesic efficacy and adverse effects of two different techniques of intravenous remifentanil consumption in patients undergoing vascular access device procedures with monitored anesthesia care. The data evaluated include; level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, patient and surgeon satisfaction, hemodynamic data and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of pain intensity rating scale in people with Opioid Use, Unspecified and Remifentanil, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 2 sites in Turkey (Türkiye).
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 3 inclusion and 9 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Numeric Pain Intensity Rating Scale (NPRS) (time frame: After incision and during operative time every five minutes, through the operative time period up to two hours of time.). The study lists 3 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 NCT04749069, which also lists 8 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 10 Feb 2021.