An interventional study of Remimazolam and Propofol in Peritoneal Neoplasms and Postoperative Recovery, sponsored by Beijing Tsinghua Chang Gung Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Supportive care
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.
Cytoreductive surgery for peritoneal surface malignancies often involves extensive peritoneal stripping, multivisceral resection, major fluid shifts, and prolonged anesthesia. Some patients also receive HIPEC. Propofol may cause vasodilation and cardiovascular depression, whereas remimazolam may provide greater hemodynamic stability. Whether this difference translates into clinically meaningful improvement in overall postoperative recovery remains uncertain.
After written informed consent and completion of baseline assessments, eligible participants will be randomized 1:1 using variable block sizes of 4, 6, or 8, stratified by whether HIPEC is planned. Allocation will be obtained from a permission-controlled electronic randomization system after eligibility is reconfirmed in the operating room and immediately before the first assigned study hypnotic. Participants, postoperative QoR-15 assessors, complication adjudicators, and the primary statistician will remain masked. Anesthesia clinicians cannot be masked because they must titrate the assigned drug.
Both groups will receive bispectral index-guided total intravenous anesthesia with a target BIS of 40 to 60 and standardized principles for analgesia, hemodynamic rescue, temperature management, neuromuscular monitoring, extubation, and intensive care. Surgery end is defined as completion of skin closure, and all postoperative assessment windows are anchored to that time.
The primary outcome is the Chinese QoR-15 total score 48 ± 4 hours after surgery. The primary analysis will use analysis of covariance or an equivalent general linear model with treatment group, baseline QoR-15 score, and planned HIPEC stratum as covariates. The adjusted between-group mean difference, 95% confidence interval, and two-sided P value will be reported. The sample size of 320 provides 90% power to detect a 6-point difference assuming a common standard deviation of 15 and allowing 15% for an unavailable primary outcome or loss to follow-up.
249 studies on the registry are indexed under Peritoneal Neoplasms; 55 are open to participants now.
This study's planned enrollment of 320 is above the median of 46 across 202 interventional studies indexed under Peritoneal Neoplasms.
Browse Peritoneal Neoplasms studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
1.Age 18 to 75 years. 2. physical status class II or III. 3. confirmed primary peritoneal surface or peritoneal from colorectal, gastric, ovarian, or appendiceal malignancy.
4.Scheduled for elective cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy under general anesthesia.
5.Expected surgical duration of at least 2 hours and planned postoperative admission to the intensive care unit.
6.Able to understand and independently complete the Chinese Quality of Recovery-15 questionnaire.
7.Willing to participate and able to provide written . Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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)
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)
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 surgery
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 surgery
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)
Proportion of valid monitoring time with mean arterial pressure below 65 mmHg
Percentage of valid invasive arterial-pressure monitoring time during which mean arterial pressure is below 65 mmHg.
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery
Lowest intraoperative mean arterial pressure
Lowest valid one-minute median mean arterial pressure, reported in mmHg, after application of prespecified artifact rules.
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Time to first vasopressor administration
Elapsed time from initiation of the assigned study hypnotic to the first vasopressor dose, reported in minutes. Participants who do not receive a vasopressor are described separately.
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Cumulative dose of vasopressors
Cumulative dose of each vasopressor is reported using the original drug units. A norepinephrine-equivalent dose may also be reported using a conversion rule finalized in the data dictionary before enrollment begins.
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Maximum vasopressor infusion rate
Maximum recorded continuous infusion rate for each vasopressor, using drug-specific units.
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Number of hypotension rescue episodes
Count of prespecified hypotension rescue episodes triggered by mean arterial pressure below 65 mmHg for at least 1 minute or any mean arterial pressure below 55 mmHg, after verification of the arterial waveform and clinical context.
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Number of study-hypnotic dose reductions due to hypotension
Count of dose reductions of the assigned study hypnotic documented as being prompted by hypotension.
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery
Incidence of acute kidney injury
Acute kidney injury is defined by any KDIGO criterion: serum creatinine increase of at least 0.3 mg/dL (26.5 µmol/L) within 48 hours, increase to at least 1.5 times baseline within the observation window, or urine output below 0.5 mL/kg/hour for 6 hours. KDIGO stage is also recorded.
Time frame: From completion of skin closure through postoperative day 7 or hospital discharge, whichever occurs first.
Incidence of postoperative infection
Occurrence of surgical-site, intra-abdominal, pulmonary, urinary-tract, catheter-related, or bloodstream infection adjudicated by masked assessors using applicable CDC/NHSN definitions and clinical, imaging, microbiological, and treatment data.
Time frame: Within 30 days after completion of skin closure
Incidence of postoperative delirium
Delirium is assessed twice daily. CAM-ICU is administered when the Richmond Agitation-Sedation Scale score is -3 or higher. Any positive CAM-ICU assessment counts as delirium for that day; reasons for inability to assess are recorded.
Time frame: Postoperative days 1 to 3 or until transfer out of the ICU, whichever occurs first.
Incidence of postoperative hypoxemia
Oxygen saturation below 90% or arterial oxygen tension below 60 mmHg lasting at least 10 minutes and requiring escalation of oxygen therapy.
Time frame: Within 7 days after completion of skin closure
Use of noninvasive ventilation
Any postoperative use of noninvasive positive-pressure ventilation for a clinical indication.
Time frame: Within 7 days after completion of skin closure.
Use of high-flow nasal cannula oxygen
Any postoperative use of high-flow nasal cannula oxygen for a clinical indication.
Time frame: Within 7 days after completion of skin closure
Incidence of respiratory failure
Postoperative respiratory failure adjudicated according to the prespecified perioperative respiratory outcome definitions.
Time frame: Within 7 days after completion of skin closure
Incidence of reintubation
Reinsertion of an endotracheal tube for a clinical indication after the first planned extubation.
Time frame: Within 7 days after the first planned extubation
Incidence of pneumonia
Postoperative pneumonia adjudicated using the prespecified clinical, imaging, microbiological, and treatment criteria. Pneumonia may also satisfy the postoperative infection definition and will be reported in both relevant outcome domains without summing event counts into a new composite outcome.
Time frame: Within 7 days after completion of skin closure
Incidence of bradycardia
Heart rate below 45 beats per minute for at least 1 minute or bradycardia requiring pharmacologic treatment.
Time frame: From the first dose of assigned study hypnotic through postoperative day 30
Incidence of study-drug allergic reactions
Any clinically diagnosed allergic or hypersensitivity reaction attributed as possibly, probably, or definitely related to a study hypnotic.
Time frame: From the first dose of assigned study hypnotic through postoperative day 30
Incidence of serious adverse events
Number and proportion of participants with at least one serious adverse event, classified and reported according to the approved protocol and ethics requirements.
Time frame: From the first dose of assigned study hypnotic through postoperative day 30
All-cause mortality
Death from any cause.
Time frame: Within 30 days after completion of skin closure
Plan to share: Undecided — The final individual participant data sharing plan has not yet been determined. Any future sharing of de-identified participant-level data and supporting materials will require applicable institutional and ethics approvals and must remain within the scope of the informed consent.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Mar 2028, 19 months later.
Of 34 interventional studies with no phase under Peritoneal Neoplasms, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 80. This study's planned 19 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remimazolam
Beijing Tsinghua Chang Gung Hospital →