Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

Tang-Du Hospital

Status and phase: Unknown; Phase 4

Conditions: Myoclonus

Treatments: Drug: midazolam，fentanyl，rocuronium; Drug: High-dose dexmedetomidine; Drug: normal saline; Drug: propofol，remifentanil，cis atracurium; Drug: Etomidate; Drug: Low-dose Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02518789

Tangdu-Eto-myo

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 3 patient groups, including a placebo group

Low-dose Dexmedetomidine

Experimental group

Description:

-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.

Treatment:

Drug: Etomidate

Drug: Low-dose Dexmedetomidine

Drug: propofol，remifentanil，cis atracurium

Drug: midazolam，fentanyl，rocuronium

High-dose Dexmedetomidine

Experimental group

Description:

-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.

Treatment:

Drug: Etomidate

Drug: propofol，remifentanil，cis atracurium

Drug: High-dose dexmedetomidine

Drug: midazolam，fentanyl，rocuronium

normal saline Control group

Placebo Comparator group

Description:

-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.

Treatment:

Drug: Etomidate

Drug: propofol，remifentanil，cis atracurium

Drug: normal saline

Drug: midazolam，fentanyl，rocuronium