Intramuscular Dexmedetomidine as Premedication

NCT01937611 | Unknown Phase 4 DMC

• 1 other identifier: 20121A021007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laryngoscopy; Preanesthetic Medication

Keywords

dexmedetomidine; intramuscular premedication; bradycardiac

Outcome Measures

Primary Outcomes (1)

• Perioperative heart rate response

  Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.

Secondary Outcomes (3)

• Sedation

  Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.

• Adjuvant anesthesia effect

  Participants will be monitored for the duration of anesthesia, an expected average of half an hour.

• Patient's over-all satisfaction

  On leaving the post-care unite, an expected average of 2 min.

Other Outcomes (1)

• Mean arterial blood pressure

  Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

dexmedetomidine 1μg•kg-1

Drug: Dexmedetomidine

midazolam

ACTIVE COMPARATOR

midazolam 0.03 mg•kg-1

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Dexmedetomidine

Also known as: Treatment

Dexmedetomidine

Midazolam DRUG

Midazolam

Also known as: control

midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University

Guangzhou, Guangdong, 510180, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 23878437 RESULT

• 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.

  PMID: 23162393 RESULT

• 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.

  PMID: 18285392 RESULT

• 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.

  PMID: 11350323 RESULT

• 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.

  PMID: 9135361 RESULT

• 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.

  PMID: 7943770 RESULT

• 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.

  PMID: 7802178 RESULT

• 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.

  PMID: 25529851 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Therapeutics; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xiangcai Ruan, MD, PhD.

  Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangcai Ruan, MD, PhD.

CONTACT

+8620-81048306; xc_ruan@hotmail.com

Huan Yang, MD.

CONTACT

+8620-81048310; yanghuan0401@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy Director

Study Record Dates

• First Submitted: September 1, 2013
• First Posted: September 9, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 9, 2013

Record last verified: 2013-09

Locations

CN (1)