Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

Tang-Du Hospital132 enrolled

Overview

By observing the difference of plasma homovanillic acid concentrations and brain electrical consciousness monitoring Narcotrend index, study the possible mechanism of influencing Etomidate induced myoclonus with Dexmedetomidine pretreatment during general anesthesia induction period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Myoclonus

Interventions

Low-dose DexmedetomidineDRUG

Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.

High-dose dexmedetomidineDRUG

Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.

normal salineDRUG

Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sign the informed consent * American Society of Anesthesiologists (ASA)classification:class I\~II;undergoing elective surgery patients * Aged between 18 and 55, 49-67 kg weight * Body Mass Index（BMI）： 20-30 kg/m2 * Did not use any analgesic or sedatives drugs within 24 h pre-operation Exclusion Criteria: * Recently patients undergoing sedative drugs and antidepressant treatment * Serious vision, hearing impairment or other reasons can not communicate * Serious neurological disease, pregnancy, diseases of the cardiovascular system； * BMI is Less than the standard 80% or higher than the standard 120%

Outcomes

Primary Outcomes

myoclonus level

* Level 0 ：no myoclonus happened; * Level 1 ：mild, tiny movement, one part of the body such as a finger or shoulder movement; * Level 2 ：moderate ,2 pieces of different muscle or slight movement of the muscle groups, such as face or legs; * Level 3 ：severely, 2 pieces or more muscle contracture intensity, such as fast outreach of limbs

Time frame: when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes

Plasma homovanillic acid concentration（PHVA）

Time frame: Measured when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes; if myoclonus does not appear,measured at 5 minutes after emulsion injection is completed.

Secondary Outcomes

Ramsay sedation score

Time frame: 1 min after entering the operating room; 1 min after dexmedetomidine injection is completed; 1 min after emulsion injection is completed;5 minutes after emulsion injection is completed；

Narcotrend index

Time frame: 1 min after entering the operating room; 1 min after dexmedetomidine injection is completed; 1 min after emulsion injection is completed;5 minutes after emulsion injection is completed；

Data from ClinicalTrials.gov

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