Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06407518

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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Postoperative Follow-up

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

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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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