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

NCT ID: NCT02111265

Last Updated: 2014-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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Conditions

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Adrenal Suppression Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Propofol

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

Group Type EXPERIMENTAL

Remifentanil

Intervention Type 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

Cisatracurium

Intervention Type 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.

Sufentanil

Intervention Type DRUG

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

Bispectral index(BIS) monitor

Intervention Type DEVICE

BiS is maintained at 40-60 during anesthesia.

Etomidate

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

Group Type EXPERIMENTAL

Remifentanil

Intervention Type 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

Cisatracurium

Intervention Type 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.

Sufentanil

Intervention Type DRUG

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

Bispectral index(BIS) monitor

Intervention Type DEVICE

BiS is maintained at 40-60 during anesthesia.

Interventions

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Remifentanil

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

Intervention Type DRUG

Cisatracurium

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.

Intervention Type DRUG

Sufentanil

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

Intervention Type DRUG

Bispectral index(BIS) monitor

BiS is maintained at 40-60 during anesthesia.

Intervention Type DEVICE

Other Intervention Names

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Ruijie

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Medical Association

NETWORK

Sponsor Role collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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He Jiaxuan

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

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SAHXJTUA01

Identifier Type: -

Identifier Source: org_study_id

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