Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety

Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Oocyte Retrieval

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

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance
• Intervention / Treatment: Drug: normal Saline; Drug: Esketamine; Drug: Remimazolam

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.

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group of patients undergoing oocyte retrieval with normal saline; Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery	Drug: normal Saline; Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery; Other Names: Group of patients undergoing oocyte retrieval with normal saline
Active Comparator: Group of patients undergoing oocyte retrieval with esketamine; Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery	Drug: Esketamine; Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery; Other Names: Group of patients undergoing oocyte retrieval with esketamine
Active Comparator: Group of patients undergoing oocyte retrieval with remimazolam; Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery	Drug: Remimazolam; Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery; Other Names: Group of patients undergoing oocyte retrieval with remimazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean intraoperative blood pressure	The mean intraoperative blood pressure was recorded	Intraoperative
Oxygen saturation	The mean intraoperative oxygen saturation was recorded	Intraoperative
Somatokinetic reaction	The number of intraoperative body movements was recorded	Intraoperative
Operation time	The duration of the patient's operation was recorded(up to 24 h)	Intraoperative
The incidence of sleep disturbance one day before surgery	Patients completed the sleep quality scales(AIS, Athens Insomnia Scale) on the day before 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 on the day before surgery to evaluate patients' preoperative sleep quality. We recorded AIS scores as statistical indicators.	one day before surgery
The incidence of postoperative sleep disturbance on the second and third postoperative nights	Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the second and third 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 second and third postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.	the second and third nights after surgery
Postoperative anxiety	Patients completed the anxiety rating scales(HADS-A,Hospital Anxiety and Depression Scale-Anxiety subscale)on the day before surgery.HADS-A consists of 7 items,each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety.And we asked the patients to fill out this questionnaire on the 1 and 2 days after surgery again to evaluate the changes in anxiety. We recorded HADS-A scores as statistical indicators.	1 day before surgery ,1 and 2 days after surgery
Postoperative depression	Patients completed the depression rating scales(HADS-D,Hospital Anxiety and Depression Scale-Depression subscale)on the day before surgery.HADS-D consists of 7 items,each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression.And we asked the patients to fill out this questionnaire on the 1 and 2 days after surgery again to evaluate the changes in depression. We recorded HADS-D scores as statistical indicators.	1 day before surgery ,1 and 2 days after surgery
Pain Score (NRS)	The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.	1 and 2 days after surgery
Duration of anesthesia	The patient's duration of anesthesia was recorded(up to 24 h)	Intraoperative
Time to walking down	Record the time from waking up to walking down(up to 24 h)	Within1 hour after surgery
Adverse event	All kinds of adverse events(PONV、hypotension、hypertension,etc) occurred in patients were recorded	Within 3 days after surgery

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital
• Investigators: Study Director: Guolin Wang, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Actual): May 10, 2025
• Study Completion (Actual): May 20, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Esketamine; oocyte retrieval; Remimazolam
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Esketamine; Saline Solution; remimazolam
• Other Study ID Numbers: GWang027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No