Esketamine and Remimazolam for Postoperative Sleep and Anxiety Relief

Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies

This study is testing whether using esketamine and remimazolam during gastroenteroscopy can help patients sleep better and feel less anxious after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: Tianjin Medical University General Hospital (other)
• Locations: 1 site (Tianjin)
• Trial ID: NCT06108830 on ClinicalTrials.gov

What this trial studies

This study investigates the combined effects of esketamine and remimazolam on postoperative sleep disturbances and anxiety in patients undergoing gastroenteroscopy. It aims to address the high incidence of postoperative sleep disorders, which can lead to complications such as delirium and delayed recovery. The study will involve administering these medications during surgery to evaluate their impact on sleep quality and anxiety levels postoperatively. Participants will be monitored for improvements in sleep patterns and overall recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20-65 years undergoing elective surgery with an ASA classification of I-III and a BMI between 19-30 kg/m2.

Not a fit: Patients with a history of neurological diseases, chronic pain, or severe comorbidities such as coronary heart disease or respiratory failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve postoperative recovery and quality of life for surgical patients by reducing sleep disturbances and anxiety.

How similar studies have performed: While the combination of esketamine and remimazolam is a novel approach, previous studies have shown promise in using these agents individually for managing postoperative symptoms.

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.

Where this trial is running

Tianjin

• Tianjin Medical University General Hospital — Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Guolin Wang, MD

Conditions: Sleep Disturbance, Esketamine, remimazolam, anxiety, gastroenteroscopy