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

NCT ID: NCT06108830

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-10

Brief Summary

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

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 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.

Conditions

Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group of patients undergoing gastroenteroscopies with normal saline

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

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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

Group of patients undergoing gastroenteroscopies with esketamine

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

Group Type: ACTIVE_COMPARATOR

Esketamine

Intervention Type: DRUG

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

Group of patients undergoing gastroenteroscopies with remimazolam

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

Group Type: ACTIVE_COMPARATOR

Remimazolam

Intervention Type: DRUG

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

Group of patients undergoing gastroenteroscopies with remimazolam and esketamine

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

Group Type: ACTIVE_COMPARATOR

Esketamine and remimazolam

Intervention Type: DRUG

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

Interventions

Esketamine

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

Intervention Type: DRUG

Remimazolam

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

Intervention Type: DRUG

Esketamine and remimazolam

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

Intervention Type: DRUG

normal saline

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

Intervention Type: DRUG

Other Intervention Names

Group of patients undergoing gastroenteroscopies with esketamine; Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began; Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began; Group of patients undergoing gastroenteroscopies with normal saline

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guolin Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guolin Wang

Role: STUDY_DIRECTOR

Tianjin Medical University General Hospital

Locations

Tianjin Medical University General Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Guolin Wang, MD

Role: CONTACT

wangguolinghad@hotmail.com

+8615822855556

Facility Contacts

Guolin Wang

Role: primary

+8618604755166

Other Identifiers

GWang024

Identifier Type: -

Identifier Source: org_study_id