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

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

Study Contact Backup

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Affiliated First People's Hospital of Guangzhou, Guangzhou Medical University
        • Contact:

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:
  • Treatment
ACTIVE_COMPARATOR: midazolam
midazolam 0.03 mg•kg-1
Midazolam
Other Names:
  • control

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

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

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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