Actively Recruiting
Preoperative Oral Midazolam to Postoperative Pain Relief in Sleep Disturbance or Anxiety Patients With Colorectal Cancer
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-04-06
280
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Previous studies have indicated a high incidence of sleep disturbances and anxiety symptoms in individuals with colorectal cancers prior to undergoing surgery, leading to worsened postoperative pain, slower recovery, and higher risk of chronic pain. The enhancement of sleep quality is intricately linked to reducing stress. Preoperative drugs that combine hypnosis and anti-anxiety have not been studied in colorectal cancer patients. Midazolam oral solution is safe and effective for short-term hypnotic and anti-anxiety effects in clinical preoperative settings. In the current randomized controlled clinical trial, 280 patients experiencing sleep disturbance or anxiety prior to colorectal cancer surgery will receive midazolam solution to assess its potential efficacy in reducing postoperative pain, expediting recovery, and decreasing the likelihood of chronic pain. Additionally, the study aims to explore the potential connections between midazolam administration and reductions in stress and inflammation.
CONDITIONS
Official Title
Preoperative Oral Midazolam to Postoperative Pain Relief in Sleep Disturbance or Anxiety Patients With Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent voluntarily
- Native Chinese speaker
- Age 18-60 years old, male or female
- BMI between 18 and 30 kg/m2
- American Society of Anesthesiologists (ASA) grade 1 or 2
- New York Heart Association (NYHA) grade I or II
- Scheduled for non-emergency laparoscopic colorectal cancer resection
- Planned general anesthesia with tracheal intubation
- Experiencing sleep disturbance (Insomnia Severity Index score 65) or anxiety (Generalized Anxiety Disorder scale-7 score 610) from admission to surgery
You will not qualify if you...
- Contraindications for Midazolam Oral Solution
- High risk of obstructive sleep apnea symptoms (STOP-Bang score 653)
- Suspected dementia (Mini-Mental State Examination score below education-adjusted thresholds)
- Severe depressive symptoms within two weeks (Patient Health Questionnaire-9 score 6515)
- History of neurological or psychiatric diseases
- History of chronic obstructive pulmonary disease
- History of heart failure
- Current intestinal obstruction
- Liver or renal insufficiency
- Use of opioids or central nervous system drugs within one week
- Use of CYP3A4 isoenzyme inhibitors or inducers within one week
- Alcohol consumption within 24 hours
- Substance abuse including alcohol, drugs, or addictive substances
- Pregnant or lactating women
AI-Screening
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Trial Site Locations
Total: 1 location
1
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
S
Sanqing Jin, MD
CONTACT
Y
Yan Zhou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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