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Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus During General Anesthesia Induction Period

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02518789
Enrollment
132
Registered
2015-08-10
Start date
2015-09-30
Completion date
2016-09-30
Last updated
2015-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myoclonus

Keywords

myoclonus, Etomidate, Dexmedetomidine

Brief summary

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.

Interventions

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

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

DRUGnormal saline

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

DRUGEtomidate

After 90 seconds of Pretreatment,intravenous infusion of etomidate fat emulsion 0.3mg/kg. -Does not offer any other drugs within 5 min after completion of etomidate.

DRUGmidazolam,fentanyl,rocuronium

Anesthesia induction:Intravenous injection midazolam 0.03 \ 0.05 mg/kg, fentanyl 5 \ 8 g/kg, rocuronium 0.6 mg/kg

DRUGpropofol,remifentanil,cis atracurium

Anesthesia maintenance:Intravenous infusion of propofol 4 \ 6 mg/kg/h, remifentanil 0.1 \ 0.3 μg/kg/min, intermittent intravenous injection of cis atracurium 0.05 \ 0.1mg/kg

Sponsors

Tang-Du Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frameDescription
myoclonus levelwhen myoclonus occurs after emulsion injection is completed,assessed up to 5 minutes* 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
Plasma homovanillic acid concentration(PHVA)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

MeasureTime frame
Ramsay sedation score1 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 index1 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;

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026