Remimazolam Versus Propofol for Early Recovery After Cytoreductive Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tsinghua Chang Gung Hospital
About this trial
The REPAIR Trial is a single-center, prospective, randomized, parallel-group superiority trial enrolling 320 adults scheduled for elective cytoreductive surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC). Participants will be assigned 1:1 to bispectral index-guided remimazolam- or propofol-based general anesthesia under standardized perioperative care. The primary objective is to determine whether remimazolam improves patient-reported recovery 48 ± 4 hours after surgery, measured by the Chinese 15-item Quality of Recovery score (QoR-15; range, 0 to 150; higher scores indicate better recovery). The investigators hypothesize that remimazolam will produce a higher 48-hour QoR-15 score than propofol. Secondary outcomes will characterize recovery at 24 and 72 hours, intraoperative hypotension burden and vasopressor use, acute kidney injury, infection, delirium, respiratory complications, other safety events, and 30-day mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Emergency surgery.
Uncontrolled bacterial, fungal, or viral infection requiring systemic anti-infective treatment within 14 days before surgery, or temperature of 38.0 °C or higher at post-consent eligibility confirmation with corresponding clinical, imaging, microbiological, or laboratory evidence. Perioperative antimicrobial prophylaxis is not an exclusion.
Child-Pugh class C, total bilirubin greater than 3 times the upper limit of normal, or alanine or aspartate aminotransferase greater than 5 times the upper limit of normal.
Estimated glomerular filtration rate below 30 mL/min/1.73 m² or maintenance renal replacement therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugRemimazolam is infused intravenously at 6 mg/kg/hour for induction. If a Modified Observer's Assessment of Alertness/Sedation score of 1 or lower is not reached after 3 minutes, the rate is increased to 12 mg/kg/hour. After loss of consciousness, maintenance starts at 1.0 mg/kg/hour and is adjusted in steps of 0.2 mg/kg/hour at intervals of at least 5 minutes within an allowed range of 0.5 to 2.0 mg/kg/hour to maintain BIS 40 to 60. Infusion stops at completion of skin closure. Dosing weight is actual body weight for BMI below 30 kg/m² and adjusted body weight for BMI of 30 kg/m² or higher. Flumazenil is not used routinely and is reserved for clinically indicated rescue.
Propofol
DrugPropofol 1.5 to 2.5 mg/kg is administered intravenously over 60 to 90 seconds for induction. After loss of consciousness, maintenance starts at 6 mg/kg/hour and is adjusted in steps of 1 mg/kg/hour at intervals of at least 5 minutes. The usual range is 4 to 10 mg/kg/hour and the allowed range is 3 to 12 mg/kg/hour to maintain BIS 40 to 60. Infusion stops at completion of skin closure. Dosing weight is actual body weight for BMI below 30 kg/m² and adjusted body weight for BMI of 30 kg/m² or higher.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: RemimazolamExperimental treatment 1 intervention
Group B: PropofolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Recovery-15 total score at 48 hours
The validated Chinese QoR-15 contains 15 items scored from 0 to 10. The total score ranges from 0 to 150, with higher scores indicating better recovery. The first valid assessment within the prespecified window is used. If any item cannot be completed, the total score is missing rather than prorated. Participants who die before the assessment window are not assigned a score of zero; mortality is reported separately and addressed in prespecified sensitivity analyses.
Time frame
48 ± 4 hours after the end of surgery, defined as completion of skin closure (allowable window, 44 to 52 hours)Secondary outcomes
1
Quality of Recovery-15 total score at 24 hours
Chinese QoR-15 total score, ranging from 0 to 150, with higher scores indicating better recovery. The first valid assessment in the prespecified window is used.
Time frame
24 ± 2 hours after completion of skin closure (allowable window, 22 to 26 hours)2
Cumulative duration of mean arterial pressure below 65 mmHg
Total number of valid monitored minutes with mean arterial pressure below 65 mmHg.
Time frame
From initiation of the assigned study hypnotic until completion of skin closure during the index surgery3
Time-weighted average of mean arterial pressure below 65 mmHg
TWA-MAP65 is calculated as the area under the threshold of 65 mmHg divided by valid arterial-pressure monitoring time. It reflects both depth and duration of hypotension and is reported in mmHg. Invasive arterial pressure data are summarized as one-minute medians after prespecified artifact handling.
Time frame
From initiation of the assigned study hypnotic until completion of skin closure during the index surgery4
Quality of Recovery-15 total score at 72 hours
Chinese QoR-15 total score, ranging from 0 to 150, with higher scores indicating better recovery. Participants discharged before the visit may complete the assessment by a masked telephone interview.
Time frame
72 ± 6 hours after completion of skin closure (allowable window, 66 to 78 hours)Sponsors and contacts
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Source ClinicalTrials.gov
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