Clinical Trials Directory

Trials / Unknown

UnknownNCT01937611

Intramuscular Dexmedetomidine as Premedication

Comparison of Dexmedetomidine and Midazolam as Intramuscular Premedication for Suspension Laryngoscopy

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Guangzhou First People's Hospital · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGDexmedetomidineDexmedetomidine
DRUGMidazolamMidazolam

Timeline

Start date
2013-03-01
Primary completion
2013-10-01
Completion
2013-10-01
First posted
2013-09-09
Last updated
2013-09-09

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01937611. Inclusion in this directory is not an endorsement.