Remimazolam for Postoperative Sleep in Elderly Patients | NCT07740343

NCT07740343

Overview

NCT ID: NCT07740343
Lead Sponsor: General Hospital of Ningxia Medical UniversityOTHER
Official Title: Remimazolam and Postoperative Sleep in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection: A Randomized, Double-Blind, PSG-Based Controlled Trial
Brief Summary: Postoperative sleep disturbance (PSD) is highly prevalent in elderly patients undergoing laparoscopic radical resection of colorectal cancer. Although remimazolam has shown favorable sedative properties and may alleviate perioperative stress, its effects on postoperative sleep architecture remain poorly understood. Polysomnography (PSG), the gold standard for objective sleep assessment, has not been widely used to evaluate these effects in this population. Therefore, this study employs a randomized controlled trial design to verify whether remimazolam is superior to propofol in preserving postoperative sleep quality, thereby offering more evidence-based options for anesthetic management in elderly patients undergoing laparoscopic colorectal cancer surgery.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Jan 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Aged between 65 and 80 years.

Scheduled for elective laparoscopic radical resection of colorectal cancer.

American Society of Anesthesiologists (ASA) physical status class II-III.

Able to understand the study protocol and provide written informed consent.

Exclusion Criteria:

Known allergy to any study medications.

Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] score > 10).

Regular use of sedatives, antipsychotics or hormonal drugs within the past month.

Preoperative cognitive impairment, screened using the education-adjusted Mini-Mental State Examination (MMSE).

Preoperative history of neurological or psychiatric disorders, including Alzheimer's disease, Parkinson's disease, depression and anxiety disorders.

Severe preoperative comorbidities involving the cardiovascular, cerebrovascular, respiratory, hepatic or renal systems, as follows:New York Heart Association (NYHA) functional class IV; current or recent (within 2 months) congestive heart failure; myocardial infarction or coronary stent implantation within the preceding 3 months; Uncontrolled frequent ventricular premature beats (>5 beats per minute), couplets, triplets, paired ventricular arrhythmias, multifocal ventricular premature beats, or R-on-T phenomenon; Second-degree atrioventricular block (Mobitz II type), third-degree atrioventricular block or sick sinus syndrome without pacemaker implantation; Stroke or transient ischemic attack within the preceding 3 months; Severe hypertension (blood pressure ≥ 180/110 mmHg); Severe respiratory tract infection (including common cold), or maximal voluntary ventilation (MMV) < 30% of the predicted value; Severe hepatic dysfunction (Child-Pugh score > 9); Acute or chronic renal failure without renal replacement therapy: Acute kidney injury was defined as an absolute increase in serum creatinine ≥ 0.3 mg/dL (≥26.5 μmol/L) or a relative increase ≥ 50% from baseline, or urine output < 0.5 mL/(kg·h) for more than 6 consecutive hours. Chronic renal failure or uremia was defined as serum creatinine > 451 μmol/L and estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².

Severe coagulation disorders.

Refusal to participate in the trial.

Anticipated postoperative admission to the intensive care unit (ICU).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 84Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Masking Description

A randomized, double-blind, controlled design was employed in this study. Patients were randomly assigned to receive either remimazolam or propofol for anesthesia induction and maintenance. Both patients and outcome assessors were fully blinded to group allocation and the type of study drug administered.

Investigators (anesthesiologists) performed anesthesia according to pre-assigned blinded codes and did not participate in any outcome assessment. Outcome assessors were independent, well-trained researchers who were not involved in anesthesia or clinical care; they solely conducted postoperative sleep monitoring, scale scoring, and data collection.

All study medications, including remimazolam and propofol, were prepared, labeled, and coded by an independent third party who did not take part in any clinical treatment or assessment procedures. This design effectively eliminated observer bias and measurement bias, ensuring the objectivity and reliability of the results.