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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 Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02783846
Enrollment
73
Registered
2016-05-26
Start date
2016-06-30
Completion date
2016-08-31
Last updated
2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loss of Consciousness

Keywords

Propofol, Dexmedetomidine, Dose, Bispectral index monitor

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.

Interventions

OTHERnormal saline

receive equal volume of normal saline

DRUGdexmedetomidine 0.5 µg/kg

receive dexmedetomidine 0.5 µg/kg

DRUGdexmedetomidine 1.0 µg/kg

receive dexmedetomidine 1.0 µg/kg

Sponsors

General Hospital of Ningxia Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousnessTo infuse dexmedetomidine and saline completely ten minutes after

Secondary

MeasureTime frame
The bispectral index values when patients loss of consciousnessTo infuse dexmedetomidine and saline completely ten minutes after

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026