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

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02174120
• Other study ID #: 20140623
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 24, 2014
• Last updated: June 24, 2014
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2014
• Source: Henan Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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: ? or ? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia
• Target Controlled Infusion

Intervention

Drug:
• propofol

• etomidate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	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.	Baseline to the end of the operation, expected to be about 6 h	Yes
Primary	Blood pressure	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.	Baseline to the end of the operation, expected to be about 6 h	Yes
Primary	Concentration of cortisol	Concentration of cortisol should be recorded before induction, 30 min, 1 h, 2 h after intubation, and immediately when the operation is over.	from baseline to the end of the operation, expected to be about 6 h	No
Secondary	Use of vasoactive agent	The name and dose of the vasoactive agents used from the beginning of induction to the end of operation.	from the beginning of induction to the end of the operation, expected to be about 6 h	Yes
Secondary	The time from stop of remifentanil to awake		The time from stop of remifentanil to awake, expected to no more than 15 min	Yes
Secondary	Severity of agitation		Within 24 h after the operation	Yes
Secondary	Postoperative nausea and vomiting		Within 24 h after the operation	Yes
Secondary	Dose of etomidate and propofol		From the beginning of induction to the end of the operation, expected to be about 6 h	No
Secondary	Intraoperative awareness		From the beginning of induction to the end of the operation, expected to be about 6 h	No
Secondary	Expense of anesthetics		From the beginning of induction to the end of the operation, expected to be about 6 h	No
Secondary	Allergic reaction		From beginning of induction to 24 h after the operation	Yes