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

General Hospital of Ningxia Medical University

Status: Completed

Conditions: Loss of Consciousness

Treatments: Drug: dexmedetomidine 1.0 µg/kg; Drug: dexmedetomidine 0.5 µg/kg; Other: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02783846

MHX00123

Details and patient eligibility

About

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

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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73 participants in 3 patient groups, including a placebo group

Group control

Placebo Comparator group

Description:

24 eligible patients are received equal volumes of saline intravenously for 10 minutes

Treatment:

Other: normal saline

Group dexmedetomidine 0.5 µg/kg

Active Comparator group

Description:

24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes

Treatment:

Drug: dexmedetomidine 0.5 µg/kg

Group dexmedetomidine 1.0 µg/kg

Active Comparator group

Description:

25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes

Treatment:

Drug: dexmedetomidine 1.0 µg/kg