Comparing esketamine and remimazolam for sleep issues after surgery
Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Oocyte Retrieval
This study is testing whether esketamine or remimazolam can help improve sleep for patients after surgery to retrieve eggs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Tianjin Medical University General Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06284668 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effects of esketamine and remimazolam on postoperative sleep disturbances in patients undergoing oocyte retrieval. Postoperative sleep disturbances can lead to complications such as delirium and delayed recovery. Esketamine, known for its analgesic and sedative properties, and remimazolam, a new benzodiazepine, will be evaluated for their effectiveness in improving sleep quality after surgery. The study will involve administering these medications during surgery and assessing their impact on postoperative sleep.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 undergoing elective surgery with a BMI between 19-30.
Not a fit: Patients with a history of neurological diseases, chronic pain, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of postoperative sleep disturbances, enhancing recovery for surgical patients.
How similar studies have performed: While the specific combination of esketamine and remimazolam is novel, studies on postoperative sleep disturbances have shown varying degrees of success with different sedative approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tianjin
- Tianjin Medical University General Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Guolin Wang
- Email: wangguolinghad@hotmail.com
- Phone: +8615822855556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.