LaryngoscopyPhase 4NCT01937611
Intramuscular Dexmedetomidine as Premedication
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Laryngoscopy and Preanesthetic Medication, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
Many studies have been conducted for the feasibility of using dexmedetomidine as premedication. However, bradycardia and hypotension frequently occurred following the premedication with dexmedetomidine, either via intramuscular or intravenous route. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Laryngoscopy, Preanesthetic Medication
- What is being tested?
- Dexmedetomidine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Oct 2013
- Phase
- Phase 4
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-55 years old, American Society of Anaesthesiologists physical status I, scheduled for elective suspension laryngoscopic surgery of benign vocal fold lesions.
Who cannot join
- Patients with neurological deficits
- Pregnancy
- Imprisonment
- Morbid obesity (body mass index ≥ 30 kg•m-2)
- Preoperative heart rate <45 beats•min-1
- Second or third degree atrioventricular block
- Antihypertensive medication with α-methyldopa, clonidine or other α2-adrenergic agonist
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University
Guangzhou, Guangdong, 510180
Jinhong Wang, Bs, +8620-81048178, gzhosp@163.com
About this study
Official title: Comparison of Dexmedetomidine and Midazolam as Intramuscular Premedication for Suspension Laryngoscopy
Many studies have been conducted for the feasibility of using dexmedetomidine as premedication. However, bradycardia and hypotension frequently occurred following the premedication with dexmedetomidine, either via intramuscular or intravenous route. This is particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2 μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes. Most studies using high-dose dexmedetomidine were predominantly adopted with the dose-finding study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of intramuscular dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1 midazolam. However, few investigations have addressed the clinical effects of low-dose dexmedetomidine as premedication. Considering modern anaesthesia has advanced a long way towards eliminating the routine need for a deep preoperative sedation. It has, therefore, become desirable to asses dexmedetomidine as an effective premedication using a moderate sedative dose to minimize its undesired hemodynamic effects. We set a prospective study to compare the sedative, haemodynamic, adjuvant anaesthetic effects and patient's satisfaction of low-dose dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used premedication, used as an intramuscular injective administration in patients undergoing suspension laryngoscopic surgery under general anaesthesia.
- Conditions
- Laryngoscopy, Preanesthetic Medication
- Being tested
- Dexmedetomidine, Midazolam
- Keywords
- dexmedetomidine, intramuscular premedication, bradycardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Treatment
Dexmedetomidine
MidazolamDrug
Also called control
Midazolam
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | dexmedetomidine 1μg•kg-1 Receives: Drug: Dexmedetomidine |
| midazolam | Active comparator | midazolam 0.03 mg•kg-1 Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative heart rate response
Measured: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
Secondary outcomes (3)
Sedation
Measured: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
Adjuvant anesthesia effect
Target-controlled infusion concentrations of propofol and remifentanyl at intubation, start and completion of surgery.
Measured: Participants will be monitored for the duration of anesthesia, an expected average of half an hour.
Patient's over-all satisfaction
On discharge from recovery patients were asked to rate their satisfaction with the anaesthesia and the surgery that they had received as; highly satisfactory, acceptable, or unacceptable.
Measured: On leaving the post-care unite, an expected average of 2 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
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 LaryngoscopyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, Guangzhou First People's Hospital
- Investigators
- Xiangcai Ruan, MD, PhD., Principal investigator, Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937611
- Sponsor's protocol ID
- 20121A021007
- Status last verified
- Sep 2013
- First submitted
- 1 Sep 2013
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jayaraman L, Sinha A, Punhani D. A comparative study to evaluate the effect of intranasal dexmedetomidine versus oral alprazolam as a premedication agent in morbidly obese patients undergoing bariatric surgery. J Anaesthesiol Clin Pharmacol. 2013 Apr;29(2):179-82. doi: 10.4103/0970-9185.111680.
PubMed 23878437Gupta K, Jain M, Gupta PK, Rastogi B, Saxena SK, Manngo A. Dexmedetomidine premedication for fiberoptic intubation in patients of temporomandibular joint ankylosis: A randomized clinical trial. Saudi J Anaesth. 2012 Jul;6(3):219-23. doi: 10.4103/1658-354X.101211.
PubMed 23162393Mowafi HA, Aldossary N, Ismail SA, Alqahtani J. Effect of dexmedetomidine premedication on the intraocular pressure changes after succinylcholine and intubation. Br J Anaesth. 2008 Apr;100(4):485-9. doi: 10.1093/bja/aen020. Epub 2008 Feb 19.
PubMed 18285392Peden CJ, Cloote AH, Stratford N, Prys-Roberts C. The effect of intravenous dexmedetomidine premedication on the dose requirement of propofol to induce loss of consciousness in patients receiving alfentanil. Anaesthesia. 2001 May;56(5):408-13. doi: 10.1046/j.1365-2044.2001.01553.x.
PubMed 11350323Taittonen MT, Kirvela OA, Aantaa R, Kanto JH. Effect of clonidine and dexmedetomidine premedication on perioperative oxygen consumption and haemodynamic state. Br J Anaesth. 1997 Apr;78(4):400-6. doi: 10.1093/bja/78.4.400.
PubMed 9135361Erkola O, Korttila K, Aho M, Haasio J, Aantaa R, Kallio A. Comparison of intramuscular dexmedetomidine and midazolam premedication for elective abdominal hysterectomy. Anesth Analg. 1994 Oct;79(4):646-53. doi: 10.1213/00000539-199410000-00006.
PubMed 7943770Virkkila M, Ali-Melkkila T, Kanto J, Turunen J, Scheinin H. Dexmedetomidine as intramuscular premedication for day-case cataract surgery. A comparative study of dexmedetomidine, midazolam and placebo. Anaesthesia. 1994 Oct;49(10):853-8. doi: 10.1111/j.1365-2044.1994.tb04257.x.
PubMed 7802178Sun Y, Liu C, Zhang Y, Luo B, She S, Xu L, Ruan X. Low-dose intramuscular dexmedetomidine as premedication: a randomized controlled trial. Med Sci Monit. 2014 Dec 18;20:2714-9. doi: 10.12659/MSM.891051.
PubMed 25529851
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine and Midazolam as Intramuscular Premedication for Suspension Laryngoscopy
- ClinicalTrials.gov ID
- NCT01937611
- Acronym / sponsor ID
- 20121A021007
- Conditions
- Laryngoscopy, Preanesthetic Medication
- Keywords
- dexmedetomidine, intramuscular premedication, bradycardiac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 9 Sep 2013 (estimated)
- 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.
Many studies have been conducted for the feasibility of using dexmedetomidine as premedication. However, bradycardia and hypotension frequently occurred following the premedication with dexmedetomidine, either via intramuscular or intravenous route. This is particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2 μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes. Most studies using high-dose dexmedetomidine were predominantly adopted with the dose-finding study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of intramuscular dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1 midazolam. However, few investigations have addressed the clinical effects of low-dose dexmedetomidine as premedication. Considering modern anaesthesia has advanced a long way towards eliminating the routine need for a deep preoperative sedation. It has, therefore, become desirable to asses dexmedetomidine as an effective premedication using a moderate sedative dose to minimize its undesired hemodynamic effects. We set a prospective study to compare the sedative, haemodynamic, adjuvant anaesthetic effects and patient's satisfaction of low-dose dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used premedication, used as an intramuscular injective administration in patients undergoing suspension laryngoscopic surgery under general anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidinedexmedetomidine 1μg•kg-1 |
| midazolam | Active comparator | Drug: Midazolammidazolam 0.03 mg•kg-1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients aged 18-55 years old, American Society of Anaesthesiologists physical status I, scheduled for elective suspension laryngoscopic surgery of benign vocal fold lesions.
Key exclusion criteria (7 listed)
- Patients with neurological deficits
- Pregnancy
- Imprisonment
- Morbid obesity (body mass index ≥ 30 kg•m-2)
- Preoperative heart rate <45 beats•min-1
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 |
|---|---|---|
| DexmedetomidineAlso: TreatmentDexmedetomidine | Drug | Dexmedetomidine |
| MidazolamAlso: controlMidazolam | Drug | midazolam |
Primary outcome
Perioperative heart rate response
Time frame: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
3 secondary outcomes
Sedation
Time frame: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
Adjuvant anesthesia effect
Time frame: Participants will be monitored for the duration of anesthesia, an expected average of half an hour.
Patient's over-all satisfaction
Time frame: On leaving the post-care unite, an expected average of 2 min.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Results publication: PubMed 23878437Jayaraman L, Sinha A, Punhani D. A comparative study to evaluate the effect of intranasal dexmedetomidine versus oral alprazolam as a premedication agent in morbidly obese patients undergoing bariatric surgery. J Anaesthesiol Clin Pharmacol. 2013 Apr;29(2):179-82. doi: 10.4103/0970-9185.111680.
- Results publication: PubMed 23162393Gupta K, Jain M, Gupta PK, Rastogi B, Saxena SK, Manngo A. Dexmedetomidine premedication for fiberoptic intubation in patients of temporomandibular joint ankylosis: A randomized clinical trial. Saudi J Anaesth. 2012 Jul;6(3):219-23. doi: 10.4103/1658-354X.101211.
- Results publication: PubMed 18285392Mowafi HA, Aldossary N, Ismail SA, Alqahtani J. Effect of dexmedetomidine premedication on the intraocular pressure changes after succinylcholine and intubation. Br J Anaesth. 2008 Apr;100(4):485-9. doi: 10.1093/bja/aen020. Epub 2008 Feb 19.
- Results publication: PubMed 11350323Peden CJ, Cloote AH, Stratford N, Prys-Roberts C. The effect of intravenous dexmedetomidine premedication on the dose requirement of propofol to induce loss of consciousness in patients receiving alfentanil. Anaesthesia. 2001 May;56(5):408-13. doi: 10.1046/j.1365-2044.2001.01553.x.
- Results publication: PubMed 9135361Taittonen MT, Kirvela OA, Aantaa R, Kanto JH. Effect of clonidine and dexmedetomidine premedication on perioperative oxygen consumption and haemodynamic state. Br J Anaesth. 1997 Apr;78(4):400-6. doi: 10.1093/bja/78.4.400.
- Results publication: PubMed 7943770Erkola O, Korttila K, Aho M, Haasio J, Aantaa R, Kallio A. Comparison of intramuscular dexmedetomidine and midazolam premedication for elective abdominal hysterectomy. Anesth Analg. 1994 Oct;79(4):646-53. doi: 10.1213/00000539-199410000-00006.
- Results publication: PubMed 7802178Virkkila M, Ali-Melkkila T, Kanto J, Turunen J, Scheinin H. Dexmedetomidine as intramuscular premedication for day-case cataract surgery. A comparative study of dexmedetomidine, midazolam and placebo. Anaesthesia. 1994 Oct;49(10):853-8. doi: 10.1111/j.1365-2044.1994.tb04257.x.
- Derived from this study: PubMed 25529851Sun Y, Liu C, Zhang Y, Luo B, She S, Xu L, Ruan X. Low-dose intramuscular dexmedetomidine as premedication: a randomized controlled trial. Med Sci Monit. 2014 Dec 18;20:2714-9. doi: 10.12659/MSM.891051.
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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.
Xiangcai Ruan, MD, PhD. principal investigator
Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Laryngoscopy and Preanesthetic Medication, run by Guangzhou First People's Hospital at 1 site in China.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangcai Ruan, MD, PhD. (+8620-81048306, xc_ruan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative heart rate response (time frame: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.). 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 NCT01937611, 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 9 Sep 2013.