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

Loss of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783846
• Other study ID #: MHX00123
• Status: Completed
• Phase: N/A
• First received: May 16, 2016
• Last updated: November 6, 2016
• Start date: June 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Loss of Consciousness
• Unconsciousness

Intervention

Other:
• normal saline
receive equal volume of normal saline

Drug:
• dexmedetomidine 0.5 µg/kg
receive dexmedetomidine 0.5 µg/kg
• dexmedetomidine 1.0 µg/kg
receive dexmedetomidine 1.0 µg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness		To infuse dexmedetomidine and saline completely ten minutes after	Yes
Secondary	The bispectral index values when patients loss of consciousness		To infuse dexmedetomidine and saline completely ten minutes after	Yes