Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety

Tianjin Medical University

Status: Completed

Conditions: Sleep Disturbance

Treatments: Drug: Esketamine; Drug: Remimazolam; Drug: normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06284668

GWang027

Details and patient eligibility

About

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

Full 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.

Enrollment: 315 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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315 participants in 3 patient groups, including a placebo group

Placebo Group of patients undergoing oocyte retrieval with normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: normal Saline

Group of patients undergoing oocyte retrieval with esketamine

Active Comparator group

Description:

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

Treatment:

Drug: Esketamine

Group of patients undergoing oocyte retrieval with remimazolam

Active Comparator group

Description:

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

Treatment:

Drug: Remimazolam