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

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ClinicalTrials.gov Identifier: NCT02783846

Recruitment Status : Completed

First Posted : May 26, 2016

Last Update Posted : November 8, 2016

Sponsor:

Information provided by (Responsible Party):

General Hospital of Ningxia Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Loss of Consciousness	Other: normal saline Drug: dexmedetomidine 0.5 µg/kg Drug: dexmedetomidine 1.0 µg/kg	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	The Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index
Study Start Date :	June 2016
Actual Primary Completion Date :	August 2016
Actual Study Completion Date :	August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dexmedetomidine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Group control 24 eligible patients are received equal volumes of saline intravenously for 10 minutes	Other: normal saline receive equal volume of normal saline
Active Comparator: Group dexmedetomidine 0.5 µg/kg 24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes	Drug: dexmedetomidine 0.5 µg/kg receive dexmedetomidine 0.5 µg/kg
Active Comparator: Group dexmedetomidine 1.0 µg/kg 25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes	Drug: dexmedetomidine 1.0 µg/kg receive dexmedetomidine 1.0 µg/kg

Outcome Measures

Primary Outcome Measures :

The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness [ Time Frame: To infuse dexmedetomidine and saline completely ten minutes after ]

Secondary Outcome Measures :

The bispectral index values when patients loss of consciousness [ Time Frame: To infuse dexmedetomidine and saline completely ten minutes after ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier:	NCT02783846
Other Study ID Numbers:	MHX00123
First Posted:	May 26, 2016 Key Record Dates
Last Update Posted:	November 8, 2016
Last Verified:	August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	safety

Keywords provided by General Hospital of Ningxia Medical University:


Propofol Dexmedetomidine Dose Bispectral index monitor

Additional relevant MeSH terms:

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Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic	Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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