Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety

NCT06284668 | Completed DMC

• 1 other identifier: GWang027
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval

Conditions

Sleep Disturbance

Keywords

Esketamine; Remimazolam; oocyte retrieval

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative sleep disturbance on the first night after surgery

  Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first day after surgery.The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the first postoperative night to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.

  the first night after surgery

Secondary Outcomes (12)

• The incidence of sleep disturbance one day before surgery

  one day before surgery

• The incidence of postoperative sleep disturbance on the second and third postoperative nights

  the second and third nights after surgery

• Postoperative anxiety

  1 day before surgery ,1 and 2 days after surgery

• Postoperative depression

  1 day before surgery ,1 and 2 days after surgery

• Pain Score (NRS)

  1 and 2 days after surgery

Study Arms (3)

Placebo Group of patients undergoing oocyte retrieval with normal saline

PLACEBO COMPARATOR

Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery

Drug: normal Saline

Group of patients undergoing oocyte retrieval with esketamine

ACTIVE COMPARATOR

Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery

Drug: Esketamine

Group of patients undergoing oocyte retrieval with remimazolam

ACTIVE COMPARATOR

Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery

Drug: Remimazolam

Interventions

normal Saline DRUG

Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery

Also known as: Group of patients undergoing oocyte retrieval with normal saline

Placebo Group of patients undergoing oocyte retrieval with normal saline

Esketamine DRUG

Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery

Also known as: Group of patients undergoing oocyte retrieval with esketamine

Group of patients undergoing oocyte retrieval with esketamine

Remimazolam DRUG

Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery

Also known as: Group of patients undergoing oocyte retrieval with remimazolam

Group of patients undergoing oocyte retrieval with remimazolam

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years old;
• American society of Aneshesiologists（ASA）physical status classification system is grade I-III;
• Elective surgery is proposed
• BMI of 19-30 kg/m2;
• Patients who agreed to enroll in this study voluntarily

You may not qualify if:

• Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
• Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
• History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery
• Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
• Respiratory insufficiency, respiratory failure;
• BMI\<18 kg/m2 or BMI\>30kg/m2;
• Poor compliance, unable to complete the experiment according to the study plan; Participants who have participated in clinical trials of other drugs within the last 4 weeks;
• Preoperative Pittsburgh Sleep Quality Index (PSQI) higher than 7

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

MeSH Terms

Conditions

Parasomnias

Interventions

Saline Solution; Esketamine; remimazolam

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Guolin Wang

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 29, 2024
• Study Start: March 4, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 20, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)