Using Midazolam to Improve Postoperative Pain Relief for Colorectal Cancer Patients with Anxiety or Sleep Issues
Effects of Preoperative Oral Mmidazolam on Postoperative Pain in Sleep Disturbance or Anxiety Patients Undergoing Laparoscopic Colorectal Cancer Resection- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Study
This study is testing if giving midazolam before surgery can help colorectal cancer patients with anxiety or sleep issues feel less pain and recover faster afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06407518 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of preoperative oral midazolam on postoperative pain relief in patients with colorectal cancer who experience sleep disturbances or anxiety. A total of 280 participants will be randomly assigned to receive either midazolam or a placebo before undergoing laparoscopic colorectal cancer surgery. The study aims to evaluate whether midazolam can enhance sleep quality, reduce postoperative pain, and expedite recovery. Additionally, it will explore the relationship between midazolam administration and stress reduction in these patients.
Who should consider this trial
Good fit: Ideal candidates are Chinese-speaking adults aged 18-60 with a BMI of 18-30 who are scheduled for non-emergency laparoscopic colorectal cancer surgery and exhibit sleep disturbances or anxiety.
Not a fit: Patients with contraindications for midazolam, severe depressive symptoms, or high risk of obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve postoperative pain management and recovery for colorectal cancer patients suffering from anxiety or sleep disturbances.
How similar studies have performed: Previous studies have indicated potential benefits of improving sleep quality on postoperative pain, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Signed of informed consent voluntarily; 2. Native Chinese speaker; 3. Age 18-60 years old, male or female; 4. BMI 18-30 kg/m2; 5. American Society of Anesthesiologists (ASA) grade 1 or 2, New York Heart Association (NYHA) gradeⅠor Ⅱ; 6. Non-emergency laparoscopic colorectal cancer resection; 7. General anesthesia with tracheal intubation; 8. Sleep disturbance (the Insomnia Severity Index,ISI≥15 ) or Anxiety (Generalized Anxiety Disorder scale-7,GAD-7≥10 ) from admission to surgery. Exclusion Criteria: * 1\. Contraindications for Midazolam Oral Solution (According to the Instruction for Midazolam Oral Solution); 2. High risk of Obstructive Sleep Apnea Symptoms (Total score of STOP-Bang scale ≥3 points); 3. Suspected dementia (Total score of Mini-Mental State Examination (MMSE) according to years of education: 0 year≤19 points; 1\~6 years≤22 points; above of 6 years≤26 points); 4. Severe depressive symptom within two weeks (Total score of Patient Health Questionnaire-9 (PHQ-9)≥15); 5. History of Neurological and Psychiatric diseases (According to the electronic medical record system); 6. History of Chronic Obstructive Pulmonary Disease (According to the electronic medical record system); 7. History of Heart Failure (According to the electronic medical record system); 8. Intestinal obstruction(The electronic medical record system records those who currently have any type of intestinal obstruction); 9. Liver and renal insufficiency; 10. Have taken opioids or drugs that act on the central nervous system within one week; 11. Take CYP3A4 isoenzyme inhibitors or inducers within one week (According to the Instruction for Midazolam Oral Solution); 12. Consume any alcoholic beverage within 24 hours; 13. Substance abusers (including alcohol, drugs or addictive substances); 14. Pregnant or lactating women.
Where this trial is running
Guangzhou, Guangdong
- the Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: sanqing Jin, MD — The Sixth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Sanqing Jin, MD
- Email: jinsq@mail.sysu.edu.cn
- Phone: 0086-13719366863
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.