drugset / Trial / NCT06407518

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

NCT06407518

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2024-07-24
Primary completion
2025-10
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 7 mg Oral
Subject Midazolam Small molecule 8 mg Oral
Subject Midazolam Small molecule 9 mg Oral
Subject Midazolam Small molecule 10 mg Oral

Indications