The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial

Not Applicable

Completed

• Conditions: Loss of Consciousness
• Interventions: Other: normal saline; Drug: dexmedetomidine 1.0 µg/kg; Drug: dexmedetomidine 0.5 µg/kg

• Registration Number: NCT02783846
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.

Detailed Description

It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general anaesthesia. Administration of dexmedetomidine during the preoperative period has been demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine premedication on the propofol dose requirement and bispectral index at loss of consciousness.

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-26
• Study Start: 2016-06
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-11-06
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• ASA physical status I-II
• Aged 18-65 years
• Body Mass Index 18.0～24.5 kg/m2
• Without hearing impairment

Exclusion Criteria

• Bradycardia
• Atrioventricular block
• Neurologic disorder and recent use of psychoactive medication
• Allergic to the drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group control	normal saline	24 eligible patients are received equal volumes of saline intravenously for 10 minutes
Group dexmedetomidine 1.0 µg/kg	dexmedetomidine 1.0 µg/kg	25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes
Group dexmedetomidine 0.5 µg/kg	dexmedetomidine 0.5 µg/kg	24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes

Primary Outcome Measures

Name	Time	Method
The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness	To infuse dexmedetomidine and saline completely ten minutes after

Secondary Outcome Measures

Name	Time	Method
The bispectral index values when patients loss of consciousness	To infuse dexmedetomidine and saline completely ten minutes after