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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02174120
Other study ID # 20140623
Secondary ID
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


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
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