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

NCT02174120 | Unknown Phase 4 DMC

• 1 other identifier: 20140623
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Target Controlled Infusion; General Anesthesia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (8)

• Use of vasoactive agent

  from the beginning of induction to the end of the operation, expected to be about 6 h

• 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

Study Arms (3)

Group A

EXPERIMENTAL

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.

Drug: etomidate

Group B

EXPERIMENTAL

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.

Drug: propofol

Group C

EXPERIMENTAL

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.

Drug: propofol; Drug: etomidate

Interventions

propofol DRUG

Group B; Group C

etomidate DRUG

Also known as: Fu Er Li

Group A; Group C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Interventions

Propofol; Etomidate

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 25, 2014

Record last verified: 2014-06