RecruitingNot ApplicableNCT06407518

Preoperative Oral Midazolam to Postoperative Pain Relief in Sleep Disturbance or Anxiety Patients With Colorectal Cancer

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

280 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a calming medication (midazolam) by mouth before surgery can improve sleep and reduce pain in patients with sleep problems or anxiety who are undergoing colorectal cancer surgery. Researchers are exploring whether better pre-surgery calm leads to better post-surgery recovery. **You may be eligible if...** - You are 18 to 60 years old - You are having planned (non-emergency) laparoscopic surgery to remove colorectal cancer - You have insomnia (ISI score ≥15) or significant anxiety (GAD-7 score ≥10) around the time of surgery - Your BMI is between 18 and 30 - You are a native Chinese speaker **You may NOT be eligible if...** - You have contraindications to midazolam - You have serious heart or lung conditions - You are pregnant or have other conditions that preclude participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMidazolam oral solution

Each individual administers the midazolam oral solution nightly from enrollment to the surgry.

OTHERPlacebo

Each individual administers placebo solution nightly from enrollment to the surgry.


Locations(1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06407518


Related Trials