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

The Comparison of Efficacy and Safety of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients --A Randomized Controlled Trial.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02111265

Enrollment

Registered

2014-04-11

Start date

2014-04-30

Completion date

2014-07-31

Last updated

2014-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Suppression, Hemodynamic Instability

Brief summary

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

Interventions

DRUGRemifentanil

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

DRUGCisatracurium

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.

DRUGSufentanil

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

DEVICEBispectral index(BIS) monitor

BiS is maintained at 40-60 during anesthesia.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

Healthy volunteers

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. -

Design outcomes

Primary

Measure	Time frame	Description
Effect Compartment Concentration	From the beginning of induction to paitens'left of PACU, up to 4 hours	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).

Secondary

Measure	Time frame	Description
vital signs	From the beginning of induction to skin closure, up to 3 hours	Systolic blood pressure, diastolic blood pressure, heart rate, respiration rate, pulse oxygen saturation recorded every 5 minutes during the operation.
The amount of drugs	From the beginning of induction to skin closure, up to 3 hours	The amount of narcotics, sedation and muscle relaxation used in general anesthesia arr recorded when the operation is finished.
Adrenal function	From entering the operating room to 48 h after induction of anesthesia.	1. 3 ml blood sample is collected at 5 time points including before induction,30 minutes,2 hours,24 hours, 48 hours after induction; 2. to examine the concentration of Cortisol, Aldosterone and ACTH in serum:

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026