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

Sedation Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02147678
• Other study ID #: 20140522
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 22, 2014
• Last updated: May 27, 2014
• Start date: December 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2014
• Source: Shaanxi Provincial People's Hospital
• Contact: Wenying Song
• Phone: +86-13609245447
• Email: swysong2010[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged between 60 and 80 years

2. Selective hysteroscopic operation

3. American Society of Anesthesiology (ASA) Physical Status: ? or ?

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodynamics
• Hysteroscopy
• Sedation

Intervention

Drug:
• Etomidate

• Propofol

• Remifentanil
During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2~0.4 µg/kg/min.
• Anesthesia induction
For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 µg/kg, cisatracurium 0.15 mg/kg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaanxi Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	Length of stay		from the date of admission to the day of discharge, expected to 3 days	No
Secondary	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	No
Secondary	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	No