Remimazolam Versus Propofol for Early Recovery After Cytoreductive Surgery

NCT07785557 | Not Yet Recruiting

• 1 other identifier: 27032-0-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peritoneal Neoplasms; Postoperative Recovery

Keywords

Cytoreductive surgery; Hyperthermic intraperitoneal chemotherapy; Remimazolam; Propofol; Quality of Recovery-15; Postoperative quality of recovery; Intraoperative hypotension; Total intravenous anesthesia; Peritoneal surface malignancy

Outcome Measures

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.

  48 ± 4 hours after the end of surgery, defined as completion of skin closure (allowable window, 44 to 52 hours)

Secondary Outcomes (24)

• Quality of Recovery-15 total score at 24 hours

  24 ± 2 hours after completion of skin closure (allowable window, 22 to 26 hours)

• Cumulative duration of mean arterial pressure below 65 mmHg

  From initiation of the assigned study hypnotic until completion of skin closure during the index surgery

• Time-weighted average of mean arterial pressure below 65 mmHg

  From initiation of the assigned study hypnotic until completion of skin closure during the index surgery

• Quality of Recovery-15 total score at 72 hours

  72 ± 6 hours after completion of skin closure (allowable window, 66 to 78 hours)

• Proportion of valid monitoring time with mean arterial pressure below 65 mmHg

  From initiation of the assigned study hypnotic until completion of skin closure during the index surgery

Study Arms (2)

Remimazolam

EXPERIMENTAL

Participants receive remimazolam for induction and maintenance of general anesthesia. Drug dosing is titrated using a common BIS target of 40 to 60 and the same prespecified perioperative management principles used in the comparator arm.

Drug: Remimazolam

Propofol

ACTIVE COMPARATOR

Participants receive propofol for induction and maintenance of general anesthesia. Drug dosing is titrated using a common BIS target of 40 to 60 and the same prespecified perioperative management principles used in the experimental arm.

Drug: Propofol

Interventions

Remimazolam DRUG

Remimazolam 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.

Remimazolam

Propofol DRUG

Propofol 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.

Propofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years. 2.American Society of Anesthesiologists physical status class II or III. 3.Pathologically confirmed primary peritoneal surface malignancy or peritoneal metastasis from colorectal, gastric, ovarian, or appendiceal malignancy.
• Scheduled for elective cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy under general anesthesia.
• Expected surgical duration of at least 2 hours and planned postoperative admission to the intensive care unit.
• Able to understand and independently complete the Chinese Quality of Recovery-15 questionnaire.

You may not qualify if:

• Emergency surgery.
• 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.
• Known allergy to remimazolam, benzodiazepines, propofol, or their excipients, or a contraindication to either study drug.
• Continuous or near-daily opioid use for at least 90 days before surgery, or benzodiazepine or Z-drug use on at least 5 days per week for at least 4 weeks.
• Severe cognitive, psychiatric, hearing, speech, or language impairment that prevents understanding and independent completion of the QoR-15 after standardized explanation.
• Pregnancy or breastfeeding.
• A preoperative plan for continuous epidural analgesia or another continuous regional analgesic technique that is incompatible with the study's standardized intravenous analgesia pathway.
• A specific clinical condition that, in the investigator's judgment, would make participation pose an unacceptable risk.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yi Duan, MD

CONTACT

+86-13810385311; dya01610@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Anesthesiologist

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

CN (1)