Intramuscular Dexmedetomidine as Premedication

Laryngoscopy Clinical Trial

Official title:

Comparison of Dexmedetomidine and Midazolam as Intramuscular Premedication for Suspension Laryngoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01937611
• Other study ID #: 20121A021007
• Status: Recruiting
• Phase: Phase 4
• First received: September 1, 2013
• Last updated: September 7, 2013
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: September 2013
• Source: Guangzhou First Municipal People’s Hospital
• Contact: Xiangcai Ruan, MD, PhD.
• Phone: +8620-81048306
• Email: xc_ruan[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 a-methyldopa, clonidine or other a2-adrenergic agonist

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngoscopy
• Preanesthetic Medication

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine
• Midazolam
Midazolam

Locations

Country	Name	City	State
China	Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First Municipal People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Taittonen MT, Kirvelä 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. — View Citation

Virkkilä M, Ali-Melkkilä 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean arterial blood pressure		Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.	Yes
Primary	Perioperative heart rate response		Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.	Yes
Secondary	Sedation		Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.	No
Secondary	Adjuvant anesthesia effect	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.	No
Secondary	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.	On leaving the post-care unite, an expected average of 2 min.	No