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Completed

NCT Number: NCT02783846

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

The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.

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Key information

Conditions

Loss of Consciousness Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Saline

Other

receive equal volume of normal saline

dexmedetomidine 0.5 µg/kg

Drug

receive dexmedetomidine 0.5 µg/kg

dexmedetomidine 1.0 µg/kg

Drug

receive dexmedetomidine 1.0 µg/kg

Primary outcomes

  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 outcomes

  1. The bispectral index values when patients loss of consciousness

    Time frame: To infuse dexmedetomidine and saline completely ten minutes after

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 26, 2016
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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