A Comparison Between Propofol and Etomidate in Hysteroscopy on Effect of Postoperative Sedation and Cognitive Function in Elderly Patients

Phase 4

• Conditions: Hysteroscopy; Hemodynamics; Sedation
• Interventions: Drug: Etomidate; Drug: Propofol; Drug: Remifentanil; Drug: Anesthesia induction

• Registration Number: NCT02147678
• Lead Sponsor: Shaanxi Provincial People's Hospital

Brief Summary

To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly patients

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-05
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-27
• Last Update Submitted: 2014-05-27
• Study First Posted: 2014-05-28
• Last Update Posted: 2014-05-28
• Study Start: 2014-12
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Aged between 60 and 80 years
2. Selective hysteroscopic operation
3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
4. Signed informed consent form
5. Expected operation duration is within 60 minutes

Exclusion Criteria

1. Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis
2. Long use of hormone or history of adrenal suppression
3. Allergy to trial drug or other contraindication
4. History or expected difficult airway
5. Identified, suspected abuse or long use of narcotic analgesia
6. Neuromuscular diseases
7. Mentally unstable or has a mental illness
8. Dysfunction of communication
9. Trend of malignant hyperthermia
10. Pregnant or breast-feeding women
11. Attended other trial past 30 days;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	Anesthesia induction	Etomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10\~15 μg/kg/min and 0.2\~0.4 μg/kg/min, respectively.
Group P	Remifentanil	Propofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50\~75 μg/kg/min and 0.2\~0.4 μg/kg/min, respectively.
Group P	Anesthesia induction	Propofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50\~75 μg/kg/min and 0.2\~0.4 μg/kg/min, respectively.
Group E	Etomidate	Etomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10\~15 μg/kg/min and 0.2\~0.4 μg/kg/min, respectively.
Group E	Remifentanil	Etomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10\~15 μg/kg/min and 0.2\~0.4 μg/kg/min, respectively.
Group P	Propofol	Propofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50\~75 μg/kg/min and 0.2\~0.4 μg/kg/min, respectively.

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure	Immediately after the entrance to the operating room until until 60 minutes after the operation	Mean arterial pressure will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Pulse oxygen saturation	Immediately after the entrance to the operating room until until 60 minutes after the operation	Pulse oxygen saturation will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Heart rate	Immediately after the entrance to the operating room until until 60 minutes after the operation	heart rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Respiratory rate	Immediately after the entrance to the operating room until until 60 minutes after the operation	Respiratory rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Narcotrend index	Immediately after the entrance to the operating room until until 60 minutes after the operation	Narcotrend index will be recorded immediately after the entance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.

Secondary Outcome Measures

Name	Time	Method
Score of Minimum Mental State Examination	1 day before the operation to 45 minutes after the operation	Score of Minimum Mental State Examination will be examined in preoperative visit, 10 minutes, 45 minutes after the operation
Verbal Fluency test	1 day before the operation to 60 minutes after the operation	Verbal Fluency test will be examined in preoperative visit and 60 minutes after the operation
Cerebral injury parameters	Immediately after the entrance to the operating room until until 60 minutes after the operation	2 ml blood will be collected immediately after the entrance to the operating room and 60 min after the operation, then SB-100 protein and neuron-specific enolase will be tested by enzyme-linked immunosorbent assay.
Length of stay	from the date of admission to the day of discharge, expected to 3 days