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

NCT ID: NCT02147678

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hysteroscopy Hemodynamics Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Etomidate

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

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

Anesthesia induction

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

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

Anesthesia induction

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etomidate

Intervention Type DRUG

Propofol

Intervention Type DRUG

Remifentanil

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fu Er Li

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wenying Song

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wenying Song

Role: CONTACT

+86-13609245447

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20140522

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ketamine and Closed-Loop Anesthesia System
NCT02011347 TERMINATED PHASE3