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

NCT ID: NCT02783846

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Loss of Consciousness

Keywords

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Propofol Dexmedetomidine Dose Bispectral index monitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group control

24 eligible patients are received equal volumes of saline intravenously for 10 minutes

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

receive equal volume of normal saline

Group dexmedetomidine 0.5 µg/kg

24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes

Group Type ACTIVE_COMPARATOR

dexmedetomidine 0.5 µg/kg

Intervention Type DRUG

receive dexmedetomidine 0.5 µg/kg

Group dexmedetomidine 1.0 µg/kg

25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes

Group Type ACTIVE_COMPARATOR

dexmedetomidine 1.0 µg/kg

Intervention Type DRUG

receive dexmedetomidine 1.0 µg/kg

Interventions

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normal saline

receive equal volume of normal saline

Intervention Type OTHER

dexmedetomidine 0.5 µg/kg

receive dexmedetomidine 0.5 µg/kg

Intervention Type DRUG

dexmedetomidine 1.0 µg/kg

receive dexmedetomidine 1.0 µg/kg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Gu Y, Yang F, Zhang Y, Zheng J, Wang J, Li B, Ma T, Cui X, Lu K, Ma H. The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial. BMC Anesthesiol. 2020 Apr 25;20(1):96. doi: 10.1186/s12871-020-01013-x.

Reference Type DERIVED
PMID: 32334510 (View on PubMed)

Other Identifiers

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MHX00123

Identifier Type: -

Identifier Source: org_study_id