Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients

Tianjin Medical University

Status: Enrolling

Conditions: Sleep Disturbance

Treatments: Drug: Esketamine; Drug: normal saline; Drug: Remimazolam; Drug: Esketamine and remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06108830

GWang024

Details and patient eligibility

About

To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies

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 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 and anxiety is worth exploring.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 20-65 years old;
2. ASA classification 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. ASA rating of IV or V;
5. Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
6. History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
7. Respiratory insufficiency, respiratory failure;
8. Patients who refused to use intravenous PCA for analgesia;
9. Pregnant or lactating women;
10. BMI<18 kg/m2 or BMI>30kg/m2;
11. Poor compliance, unable to complete the experiment according to the study plan;
12. Participants who have participated in clinical trials of other drugs within the last 4 weeks;
13. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups, including a placebo group

Group of patients undergoing gastroenteroscopies with normal saline

Placebo Comparator group

Description:

Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began

Treatment:

Drug: normal saline

Group of patients undergoing gastroenteroscopies with esketamine

Active Comparator group

Description:

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began

Treatment:

Drug: Esketamine

Group of patients undergoing gastroenteroscopies with remimazolam

Active Comparator group

Description:

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began

Treatment:

Drug: Remimazolam

Group of patients undergoing gastroenteroscopies with remimazolam and esketamine

Active Comparator group

Description:

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began

Treatment:

Drug: Esketamine and remimazolam