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

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

Study Overview

• Status: Unknown
• Conditions: Sedation; Hysteroscopy; Hemodynamics
• Intervention / Treatment: Drug: Propofol; Drug: Etomidate; Drug: Remifentanil; Drug: Anesthesia induction

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wenying Song; Phone Number: +86-13609245447; Email: swysong2010@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group E; 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.	Drug: Etomidate; Other Names: Fu Er Li; Drug: Remifentanil; During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2~0.4 μg/kg/min.; Drug: Anesthesia induction; For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.
EXPERIMENTAL: Group P; 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.	Drug: Propofol; Drug: Remifentanil; During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2~0.4 μg/kg/min.; Drug: Anesthesia induction; For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	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.	Immediately after the entrance to the operating room until until 60 minutes after the operation
Mean arterial pressure	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.	Immediately after the entrance to the operating room until until 60 minutes after the operation
Pulse oxygen saturation	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.	Immediately after the entrance to the operating room until until 60 minutes after the operation
Respiratory rate	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.	Immediately after the entrance to the operating room until until 60 minutes after the operation
Narcotrend index	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.	Immediately after the entrance to the operating room until until 60 minutes after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral injury parameters	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.	Immediately after the entrance to the operating room until until 60 minutes after the operation
Length of stay		from the date of admission to the day of discharge, expected to 3 days
Score of Minimum Mental State Examination	Score of Minimum Mental State Examination will be examined in preoperative visit, 10 minutes, 45 minutes after the operation	1 day before the operation to 45 minutes after the operation
Verbal Fluency test	Verbal Fluency test will be examined in preoperative visit and 60 minutes after the operation	1 day before the operation to 60 minutes after the operation

Collaborators and Investigators

• Sponsor: Shaanxi Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ANTICIPATED): February 1, 2015
• Study Completion (ANTICIPATED): February 1, 2015

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (ESTIMATE): May 28, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2014
• Last Update Submitted That Met QC Criteria: May 27, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol; Etomidate
• Other Study ID Numbers: 20140522