THe Comparison of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients

NCT02111265 | Unknown Phase 4

• 1 other identifier: SAHXJTUA01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients

Conditions

Adrenal Suppression; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Effect Compartment Concentration

  The effect compartment concentration of etomidate or propofol are recorded at three time points,including time that patient's loss of eyelash reflex,after 30 minutes of loss of eyelash reflex and when the patient is awake （call then open their eyes).

  From the beginning of induction to paitens'left of PACU, up to 4 hours

Secondary Outcomes (3)

• vital signs

  From the beginning of induction to skin closure, up to 3 hours

• The amount of drugs

  From the beginning of induction to skin closure, up to 3 hours

• Adrenal function

  From entering the operating room to 48 h after induction of anesthesia.

Study Arms (2)

Propofol

EXPERIMENTAL

Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.

Drug: Remifentanil; Drug: Cisatracurium; Drug: Sufentanil; Device: Bispectral index(BIS) monitor

Etomidate

EXPERIMENTAL

Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.

Drug: Remifentanil; Drug: Cisatracurium; Drug: Sufentanil; Device: Bispectral index(BIS) monitor

Interventions

Remifentanil DRUG

1. Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia. 2. Remifentanil is stopped before skin closure

Also known as: Ruijie

Etomidate; Propofol

Cisatracurium DRUG

1. Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia. 2. Cisatracurium is stopped before skin closure.

Etomidate; Propofol

Sufentanil DRUG

Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.

Etomidate; Propofol

Bispectral index(BIS) monitor DEVICE

BiS is maintained at 40-60 during anesthesia.

Etomidate; Propofol

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Scheduled for Endotracheal intubated and general anesthesia for general surgery patients.
• Age 60-75 yrs.
• American Society of Anesthesia (ASA) classification I-II.
• Expected time of surgery is less than 3 hours. -

You may not qualify if:

• Body mass index is more than 36kg/m2.
• Systolic blood pressure≥180 mm Hg or \<90 mm Hg，diastolic blood pressure≥110 mm Hg or \< 60 mm Hg.
• Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis.
• Long term used hormone or adrenal suppression.
• Allergy to trial drug or other contraindication.
• Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation.
• Abuse of narcotic analgesia or suspected.
• Neuromuscular diseases.
• Mentally unstable or has a mental illness.
• Malignant Hyperthermia.
• Pregnant or breast-feeding women.
• Attended other trial past 30 days. -

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead
• Chinese Medical Association: collaborator

MeSH Terms

Interventions

Remifentanil; cisatracurium; Sufentanil; Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• He Jiaxuan

  Department of Anesthesia, Second Affiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 14, 2014

Record last verified: 2014-04