The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial
The Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index
1 other identifier
interventional
73
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 8, 2016
August 1, 2016
2 months
May 16, 2016
November 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness
To infuse dexmedetomidine and saline completely ten minutes after
Secondary Outcomes (1)
The bispectral index values when patients loss of consciousness
To infuse dexmedetomidine and saline completely ten minutes after
Study Arms (3)
Group control
PLACEBO COMPARATOR24 eligible patients are received equal volumes of saline intravenously for 10 minutes
Group dexmedetomidine 0.5 µg/kg
ACTIVE COMPARATOR24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes
Group dexmedetomidine 1.0 µg/kg
ACTIVE COMPARATOR25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes
Interventions
Eligibility Criteria
You may qualify if:
- ASA physical status I-II
- Aged 18-65 years
- Body Mass Index 18.0～24.5 kg/m2
- Without hearing impairment
You may not qualify if:
- Bradycardia
- Atrioventricular block
- Neurologic disorder and recent use of psychoactive medication
- Allergic to the drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32334510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2016
First Posted
May 26, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
November 8, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share
safety