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

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called midazolam, taken before surgery, can help reduce pain after surgery in patients with colorectal cancer who are experiencing sleep disturbances or anxiety. Previous research has shown that many people with colorectal cancer have trouble sleeping and feel anxious before their surgery, which can lead to more pain and a slower recovery afterward. In this study, 280 patients between the ages of 18 and 60 will be given an oral solution of midazolam before their laparoscopic colorectal cancer surgery to see if it helps them feel less pain after the operation and speeds up their recovery.

To participate in the trial, individuals need to be native Chinese speakers, have a body mass index (BMI) between 18 and 30, and be classified as generally healthy (ASA grade 1 or 2), among other criteria. Participants will need to sign consent to join the study. Those who qualify will receive the midazolam before their surgery and will be monitored for its effects on pain, recovery time, and overall stress levels. It’s important to note that certain health issues or medications may exclude individuals from participating. This trial aims to provide valuable information on how preoperative care, like using midazolam, can improve the surgical experience for patients with colorectal cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• Exclusion Criteria:
• • 1. 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.