The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries

Phase 4

• Conditions: Target Controlled Infusion; General Anesthesia
• Interventions: Drug: etomidate; Drug: propofol

• Registration Number: NCT02174120
• Lead Sponsor: Henan Provincial People's Hospital

Brief Summary

To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Study First Posted: 2014-06-25
• Last Update Posted: 2014-06-25
• Study Start: 2014-10
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form

Exclusion Criteria

• Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	etomidate	During maintenance of anesthesia, etomidate was give by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml to keep bispectral index between 40 to 60.
Group C	propofol	During maintenance of anesthesia, etomidate will be given by target controlled infusion for 2 h first, and then propofol will be given by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml and 2 to 4 micrograms/ml, respectively. Bispectral index should be kept between 40 to 60.
Group B	propofol	During maintenance of anesthesia, Propofol was give by target controlled infusion, the effect-site concentration is 2 to 4 micrograms/ml to keep bispectral index between 40 to 60.
Group C	etomidate	During maintenance of anesthesia, etomidate will be given by target controlled infusion for 2 h first, and then propofol will be given by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml and 2 to 4 micrograms/ml, respectively. Bispectral index should be kept between 40 to 60.

Primary Outcome Measures

Name	Time	Method
Heart rate	Baseline to the end of the operation, expected to be about 6 h	Heart rate should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.
Blood pressure	Baseline to the end of the operation, expected to be about 6 h	Blood pressure should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.
Concentration of cortisol	from baseline to the end of the operation, expected to be about 6 h	Concentration of cortisol should be recorded before induction, 30 min, 1 h, 2 h after intubation, and immediately when the operation is over.

Secondary Outcome Measures

Name	Time	Method
Use of vasoactive agent	from the beginning of induction to the end of the operation, expected to be about 6 h	The name and dose of the vasoactive agents used from the beginning of induction to the end of operation.
The time from stop of remifentanil to awake	The time from stop of remifentanil to awake, expected to no more than 15 min
Severity of agitation	Within 24 h after the operation
Postoperative nausea and vomiting	Within 24 h after the operation
Dose of etomidate and propofol	From the beginning of induction to the end of the operation, expected to be about 6 h
Intraoperative awareness	From the beginning of induction to the end of the operation, expected to be about 6 h
Expense of anesthetics	From the beginning of induction to the end of the operation, expected to be about 6 h
Allergic reaction	From beginning of induction to 24 h after the operation