Actively Recruiting
Effects of Preoperative Oral Midazolam on Postoperative Pain in Sleep Disturbance or Anxiety Patients Undergoing Laparoscopic Colorectal Cancer Resection A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Study
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-04-06
280
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of preoperative oral midazolam in patients with colorectal cancer who experience sleep disturbances or anxiety before surgery. These conditions have been linked to worse postoperative pain, slower recovery, and a higher risk of developing chronic pain. The study is a prospective, randomized, double-blind, placebo-controlled clinical trial exploring whether midazolam can reduce postoperative pain and stress, as well as inflammation, in this patient group. Participants will receive either midazolam oral solution or a placebo nightly from enrollment until surgery. The midazolam dose starts at 7 mg and may be increased by 1 mg increments up to 10 mg if sleep is not achieved within 30 minutes of administration. The placebo group receives a solution identical in appearance and taste, following the same dosing pattern. This intervention is designed to promote sleep and reduce anxiety before laparoscopic colorectal cancer surgery. Throughout the study, researchers will monitor pain levels on the first three days after surgery using pain scales and record analgesic use. They will also assess recovery quality, inflammation markers, opioid consumption, hospital stay length, and incidence of complications up to 90 days after surgery. The main outcome is the occurrence of moderate to severe pain on the first postoperative day. Participants will be followed closely to evaluate both short-term recovery and longer-term chronic pain outcomes.
CONDITIONS
Brief 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 to 60 years old, male or female
- Body mass index 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 surgery
- General anesthesia with tracheal intubation planned
- Sleep disturbance with Insomnia Severity Index (ISI) 65 or anxiety with Generalized Anxiety Disorder scale-7 (GAD-7) 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 scale score 653)
- Suspected dementia based on Mini-Mental State Examination (MMSE) scores adjusted for education
- 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 kidney insufficiency
- Use of opioids or central nervous system drugs within one week
- Use of CYP3A4 enzyme 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
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until the day of surgery (variable duration)
Participants take oral midazolam solution or placebo nightly from enrollment until the day of surgery to improve sleep and reduce anxiety before laparoscopic colorectal cancer resection.
1 visit for enrollment and daily medication at home until surgery
Duration - Up to 90 days after surgery
Participants are monitored for postoperative pain, recovery, and complications up to 90 days after surgery.
Visits on postoperative days 1, 2, 3, 30, and 90
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
Y
Yan Zhou, MD
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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