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Intramuscular Dexmedetomidine as Premedication

Sponsor
Guangzhou First People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01937611
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Dexmedetomidine and Midazolam as Intramuscular Premedication for Suspension Laryngoscopy
Study Start Date :
Mar 1, 2013
Anticipated Primary Completion Date :
Oct 1, 2013
Anticipated Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexmedetomidine

dexmedetomidine 1μg•kg-1

Drug: Dexmedetomidine
Dexmedetomidine
Other Names:
  • Treatment

    		•
    Active Comparator: midazolam

    midazolam 0.03 mg•kg-1

    Drug: Midazolam
    Midazolam
    Other Names:
  • control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Perioperative heart rate response [Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.]

    Secondary Outcome Measures

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

    2. Adjuvant anesthesia effect [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.

    3. Patient's over-all satisfaction [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.

    Other Outcome Measures

    1. Mean arterial blood pressure [Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University Guangzhou Guangdong China 510180

    Sponsors and Collaborators

    • Guangzhou First People's Hospital

    Investigators

    • Principal Investigator: Xiangcai Ruan, MD, PhD., Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiangcai Ruan, Professor, Deputy Director, Guangzhou First People's Hospital
    ClinicalTrials.gov Identifier:
    NCT01937611
    Other Study ID Numbers:
    • 20121A021007
    First Posted:
    Sep 9, 2013
    Last Update Posted:
    Sep 9, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by Xiangcai Ruan, Professor, Deputy Director, Guangzhou First People's Hospital
    dexmedetomidine
    intramuscular premedication
    bradycardiac
    Additional relevant MeSH terms:
    Midazolam
    Dexmedetomidine

    Study Results

    No Results Posted as of Sep 9, 2013