- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937611
Intramuscular Dexmedetomidine as Premedication
September 7, 2013 updated by: Xiangcai Ruan, Guangzhou First People's Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiangcai Ruan, MD, PhD.
- Phone Number: +8620-81048306
- Email: xc_ruan@hotmail.com
Study Contact Backup
- Name: Huan Yang, MD.
- Phone Number: +8620-81048310
- Email: yanghuan0401@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510180
- Recruiting
- Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University
-
Contact:
- Jinhong Wang, Bs
- Phone Number: +8620-81048178
- Email: gzhosp@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dexmedetomidine
dexmedetomidine 1μg•kg-1
|
Dexmedetomidine
Other Names:
|
ACTIVE_COMPARATOR: midazolam
midazolam 0.03 mg•kg-1
|
Midazolam
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative heart rate response
Time Frame: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
|
Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedation
Time Frame: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
|
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.
|
Target-controlled infusion concentrations of propofol and remifentanyl at intubation, start and completion of surgery.
|
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.
|
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.
|
On leaving the post-care unite, an expected average of 2 min.
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean arterial blood pressure
Time Frame: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
|
Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiangcai Ruan, MD, PhD., Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Gupta 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.
- Mowafi 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.
- Peden 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.
- Taittonen 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.
- Erkola 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.
- Virkkila 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.
- Sun 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ANTICIPATED)
October 1, 2013
Study Completion (ANTICIPATED)
October 1, 2013
Study Registration Dates
First Submitted
September 1, 2013
First Submitted That Met QC Criteria
September 7, 2013
First Posted (ESTIMATE)
September 9, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 9, 2013
Last Update Submitted That Met QC Criteria
September 7, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
- Dexmedetomidine
Other Study ID Numbers
- 20121A021007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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