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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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


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




Primary Outcome Measures :
  1. 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 :
  1. The bispectral index values when patients loss of consciousness [ Time Frame: To infuse dexmedetomidine and saline completely ten minutes after ]


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