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Study of Oral Midazolam Before Laparoscopic Colorectal Cancer Surgery to Reduce Postoperative Pain, Improve Recovery, and Lower Chronic Pain Risk in Patients With Sleep Disturbance or Anxiety
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-04-06
280
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
Research Team
S
Sanqing Jin, MD
Y
Yan Zhou, MD
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