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

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

Conditions
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Sedation, Hysteroscopy, Hemodynamics

Intervention / Treatment
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* Drug: Etomidate
* Drug: Propofol
* Drug: Remifentanil
* Drug: Anesthesia induction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 60 and 80 years Selective hysteroscopic operation American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Signed informed consent form Expected operation duration is within 60 minutes Exclusion Criteria: Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis Long use of hormone or history of adrenal suppression Allergy to trial drug or other contraindication History or expected difficult airway Identified, suspected abuse or long use of narcotic analgesia Neuromuscular diseases Mentally unstable or has a mental illness Dysfunction of communication Trend of malignant hyperthermia Pregnant or breast-feeding women Attended other trial past 30 days;

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group E<br>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<br> <br> * Other names: Fu Er Li;Drug: Remifentanil<br>* During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2 0.4 μg/kg/min.<br>Drug: Anesthesia induction<br>* For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.<br>|
| Experimental: Group P<br>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<br> <br> Drug: Remifentanil<br>* During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2 0.4 μg/kg/min.<br>Drug: Anesthesia induction<br>* For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.<br>|

What is the study measuring?
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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 |