Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety

NCT ID: NCT06284668

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-05-20

Brief Summary

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

Detailed Description

Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.

Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration. Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance is worth exploring.

Conditions

Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo Group of patients undergoing oocyte retrieval with normal saline

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

Group Type: PLACEBO_COMPARATOR

normal Saline

Intervention Type: DRUG

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

Group of patients undergoing oocyte retrieval with esketamine

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

Group Type: ACTIVE_COMPARATOR

Esketamine

Intervention Type: DRUG

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

Group of patients undergoing oocyte retrieval with remimazolam

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

Group Type: ACTIVE_COMPARATOR

Remimazolam

Intervention Type: DRUG

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

Interventions

normal Saline

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

Intervention Type: DRUG

Esketamine

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

Intervention Type: DRUG

Remimazolam

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

Intervention Type: DRUG

Other Intervention Names

Group of patients undergoing oocyte retrieval with normal saline; Group of patients undergoing oocyte retrieval with esketamine; Group of patients undergoing oocyte retrieval with remimazolam

Eligibility Criteria

Inclusion Criteria

1. Age 18-45 years old;

2. American society of Aneshesiologists（ASA）physical status classification system is grade I-III;

3. Elective surgery is proposed

4. BMI of 19-30 kg/m2;

5. Patients who agreed to enroll in this study voluntarily

Exclusion Criteria

1. Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;

2. Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;

3. 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

4. Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;

5. Respiratory insufficiency, respiratory failure;

6. BMI<18 kg/m2 or BMI>30kg/m2;

7. 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;

8. Preoperative Pittsburgh Sleep Quality Index (PSQI) higher than 7

9. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guolin Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guolin Wang

Role: STUDY_DIRECTOR

Tianjin Medical University General Hospital

Locations

Tianjin Medical University General Hospital

Tianjin, , China

Countries

China

Other Identifiers

GWang027

Identifier Type: -

Identifier Source: org_study_id