Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety

Tianjin Medical University General Hospital315 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

315

Conditions

Sleep Disturbance

Interventions

normal SalineDRUG

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

EsketamineDRUG

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

RemimazolamDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tianjin Medical University General Hospital

Tianjin, China

Outcomes

Primary Outcomes

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.

Time frame: the first night after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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