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NCT Number: NCT06284668

Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety

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

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University General Hospital

Tianjin, 300052, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

normal saline

Drug

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

Esketamine

Drug

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

Other names: Group of patients undergoing oocyte retrieval with esketamine

Remimazolam

Drug

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

Other names: Group of patients undergoing oocyte retrieval with remimazolam

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. The incidence of sleep disturbance one day before surgery

    Time frame: 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.

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

    Time frame: the second and third nights after surgery

    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.

  3. Postoperative anxiety

    Time frame: 1 day before surgery ,1 and 2 days after surgery

    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.

  4. Postoperative depression

    Time frame: 1 day before surgery ,1 and 2 days after surgery

    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.

  5. Pain Score (NRS)

    Time frame: 1 and 2 days after surgery

    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.

  6. Mean intraoperative blood pressure

    Time frame: Intraoperative

    The mean intraoperative blood pressure was recorded

  7. Oxygen saturation

    Time frame: Intraoperative

    The mean intraoperative oxygen saturation was recorded

  8. Somatokinetic reaction

    Time frame: Intraoperative

    The number of intraoperative body movements was recorded

  9. Operation time

    Time frame: Intraoperative

    The duration of the patient's operation was recorded(up to 24 h)

  10. Duration of anesthesia

    Time frame: Intraoperative

    The patient's duration of anesthesia was recorded(up to 24 h)

  11. Time to walking down

    Time frame: Within1 hour after surgery

    Record the time from waking up to walking down(up to 24 h)

  12. Adverse event

    Time frame: Within 3 days after surgery

    All kinds of adverse events(PONV、hypotension、hypertension,etc) occurred in patients were recorded

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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