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

NCT02147678 | Unknown Phase 4

• 1 other identifier: 20140522
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hysteroscopy; Hemodynamics; Sedation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Cerebral injury parameters

  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

  1 day before the operation to 45 minutes after the operation

• Verbal Fluency test

  1 day before the operation to 60 minutes after the operation

Study Arms (2)

Group E

EXPERIMENTAL

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; Drug: Remifentanil; Drug: Anesthesia induction

Group P

EXPERIMENTAL

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; Drug: Anesthesia induction

Interventions

Etomidate DRUG

Also known as: Fu Er Li

Group E

Propofol DRUG

Group P

Remifentanil DRUG

During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2\~0.4 μg/kg/min.

Group E; Group P

Anesthesia induction DRUG

For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.

Group E; Group P

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shaanxi Provincial People's Hospital: lead

MeSH Terms

Interventions

Etomidate; Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines

Central Study Contacts

Wenying Song

CONTACT

+86-13609245447; swysong2010@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 28, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 28, 2014

Record last verified: 2014-05