Remimazolam for Postoperative Sleep in Elderly Patients
ConditionPostoperative Sleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorGeneral Hospital of Ningxia Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugIn the remimazolam group, anesthesia was induced with remimazolam 0.2 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium 0.6-0.8 mg/kg. After 3 minutes of preoxygenation, tracheal intubation was performed, and mechanical ventilation was initiated to maintain PETCO₂ at 30-40 mmHg. Anesthesia was maintained with continuous infusions of remimazolam and remifentanil, guided by anesthetic depth monitoring. Rocuronium was supplemented intermittently and discontinued 30 minutes before the end of surgery.Polysomnography (PSG) was performed both preoperatively and postoperatively to measure total sleep time and sleep architecture. Subjective sleep quality was assessed using validated questionnaires during postoperative follow-up.
propofol
DrugIn the propofol group, anesthesia was induced with propofol 1.0-1.5 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium 0.6-0.8 mg/kg. Anesthesia was maintained with continuous infusions of propofol and remifentanil. All other procedural details were identical to those in the remimazolam group.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Remimazolam (Group R)Experimental treatment 1 intervention
Group B: Propofol (Group P)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total sleep time (TST) on the first postoperative night
Polysomnography (PSG) was used to assess total sleep time on the first postoperative night in both groups.
Time frame
On the first postoperative nightSecondary outcomes
1
Richards-Campbell Sleep Questionnaire (RCSQ) Score
Subjective sleep quality assessed via the Richards-Campbell Sleep Questionnaire (RCSQ), ranging from 0 to 100 points, with a higher score indicating better sleep quality. Result interpretation: A total score \< 50 indicates poor sleep quality; 50 - 69 points indicate average sleep quality; ≥ 70 points indicate good sleep quality.
Time frame
Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 72
Pittsburgh Sleep Quality Index (PSQI) Score
Subjective sleep quality assessed via the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21; higher scores indicate worse sleep quality.
Time frame
1 month postoperatively3
Resting Visual Analogue Scale (VAS) Pain Score
Pain at rest was measured in both groups preoperatively and at 1, 2, and 3 days postoperatively using the Visual Analogue Scale (VAS). Scores range from 0 to 10; higher scores indicate greater pain intensity.
Time frame
at 1, 2, and 3 days postoperatively4
The incidence of postoperative delirium
The incidence of postoperative delirium was evaluated in both groups at 1, 2, and 3 days postoperatively using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM).
Time frame
at 1, 2, and 3 days postoperativelySponsors and contacts
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Source ClinicalTrials.gov