CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 280 target
Drug / intervention
Midazolam oral solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06407518
NCT06407518N/ARecruitingUpdate OverdueUpdated 14mo ago · Completion was 8mo ago
Enrollment Stalled
Update Overdue

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

Sixth Affiliated Hospital, Sun Yat-sen University·interventional·Posted May 9, 2024·Updated Apr 6, 2025

In Brief

A clinical study evaluating Midazolam oral solution and Placebo for Preoperative and 4 related conditions. Currently recruiting, targeting 280 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ARecruitingOverdue
20252026
First PostedMay 9, 2024
Enrollment StartJul 24, 2024
Primary CompletionOct 1, 2025
Study CompletionDec 1, 2025
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 2.1 years ago

Interventions

Midazolam oral solutiondrug

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

Placeboother

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