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

NCT06407518 | Recruiting DMC

• 1 other identifier: 2024ZSLYEC-351
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preoperative; Sleep Disturbance; Anxiety; Midazolam; Pain, Postoperative

Keywords

preoperative; oral midazolam; sleep disturbance; anxiety; postoperative pain; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of moderate to severe pain on the first postoperative day

  NRS: Numerical Rating Scale, NRS pain score 0-3 for mild, 4-6 for moderate, 7-10 for severe; Moderate to severe pain: Mean NRS pain score ≥4; Mean NRS pain score: Mean pain is defined as the mean of NRS scores of the severest, lightest, average, and present pain within 24 hours using the Brief Pain Inventory Short version (BPIsf).

  on the first postoperative day for Acute Postoperative Pain

Secondary Outcomes (40)

• Mean NRS pain score

  on the first postoperative day for Acute Postoperative Pain

• Mean NRS pain score

  on the second postoperative day for Acute Postoperative Pain

• Mean NRS pain score

  on the third postoperative day for Acute Postoperative Pain

• Incidence of moderate to severe pain

  on the second postoperative day for Acute Postoperative Pain

• Incidence of moderate to severe pain

  on the third postoperative day for Acute Postoperative Pain

Other Outcomes (3)

• Salivary cortisol

  Days from admission to the day of surgery (expected 5 days before surgery)

• Cytokine group

  on the surgery day (before general anesthesia and surgery)

• Endocannabinoids

  on the surgery day (before general anesthesia and surgery)

Study Arms (2)

Midazolam oral solution Group

EXPERIMENTAL

The intervention drug is midazolam oral solution at a dose of 7-10mg. The starting dosage is 7mg, with subsequent individual increases of 1mg up to a maximum dose of 10mg if patients do not achieve sleep within 30 minutes of administration. The individual dose wil be consistently maintained at the corresponding level every night until the surgery.

Drug: Midazolam oral solution

Control Group

PLACEBO COMPARATOR

Placebo is a solution of midazolam oral solution that looks, tastes, and appears the same as the intervention drug, similar to the experimental group increment method.

Other: Placebo

Interventions

Midazolam oral solution DRUG

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

Also known as: Midazolam oral solution, YICHANG HUMANWELL PHARMACEUTICAL

Midazolam oral solution Group

Placebo OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Signed of informed consent voluntarily; 2. Native Chinese speaker; 3. Age 18-60 years old, male or female; 4. BMI 18-30 kg/m2; 5. American Society of Anesthesiologists (ASA) grade 1 or 2, New York Heart Association (NYHA) gradeⅠor Ⅱ; 6. Non-emergency laparoscopic colorectal cancer resection; 7. General anesthesia with tracheal intubation; 8. Sleep disturbance (the Insomnia Severity Index,ISI≥15 ) or Anxiety (Generalized Anxiety Disorder scale-7,GAD-7≥10 ) from admission to surgery.

You may not qualify if:

• \. Contraindications for Midazolam Oral Solution (According to the Instruction for Midazolam Oral Solution); 2. High risk of Obstructive Sleep Apnea Symptoms (Total score of STOP-Bang scale ≥3 points); 3. Suspected dementia (Total score of Mini-Mental State Examination (MMSE) according to years of education: 0 year≤19 points; 1\~6 years≤22 points; above of 6 years≤26 points); 4. Severe depressive symptom within two weeks (Total score of Patient Health Questionnaire-9 (PHQ-9)≥15); 5. History of Neurological and Psychiatric diseases (According to the electronic medical record system); 6. History of Chronic Obstructive Pulmonary Disease (According to the electronic medical record system); 7. History of Heart Failure (According to the electronic medical record system); 8. Intestinal obstruction(The electronic medical record system records those who currently have any type of intestinal obstruction); 9. Liver and renal insufficiency; 10. Have taken opioids or drugs that act on the central nervous system within one week; 11. Take CYP3A4 isoenzyme inhibitors or inducers within one week (According to the Instruction for Midazolam Oral Solution); 12. Consume any alcoholic beverage within 24 hours; 13. Substance abusers (including alcohol, drugs or addictive substances); 14. Pregnant or lactating women.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Parasomnias; Anxiety Disorders; Pain, Postoperative; Colorectal Neoplasms

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• sanqing Jin, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanqing Jin, MD

CONTACT

0086-13719366863; jinsq@mail.sysu.edu.cn

Yan Zhou, MD

CONTACT

0086-13632404420; zhouyan8@mail3.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 9, 2024
• Study Start: July 24, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)