Peritoneal NeoplasmsREPAIRNCT07785557
Remimazolam Versus Propofol for Early Recovery After Cytoreductive Surgery
A study testing Remimazolam and Propofol in people with Peritoneal Neoplasms and Postoperative Recovery, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Neoplasms, Postoperative Recovery
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.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.
- 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 informed consent. Exclusion Criteria
- Emergency surgery.
Show all 15Show fewer
- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Yi Duan, MD, +86-13810385311, dya01610@btch.edu.cn
dya01610@btch.edu.cn
About this study
Official title: Effect of Remimazolam Versus Propofol on Early Postoperative Quality of Recovery in Patients Undergoing Cytoreductive Surgery for Peritoneal Surface Malignancies: A Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Peritoneal Neoplasms, Postoperative Recovery
- Being tested
- Remimazolam, Propofol
- Keywords
- Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, Remimazolam, Propofol, Quality of Recovery-15, Postoperative quality of recovery, Intraoperative hypotension, Total intravenous anesthesia, Peritoneal surface malignancy
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
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.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 7 days after completion of skin closure
Use of noninvasive ventilation
Any postoperative use of noninvasive positive-pressure ventilation for a clinical indication.
Measured: 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.
Measured: Within 7 days after completion of skin closure
Incidence of respiratory failure
Postoperative respiratory failure adjudicated according to the prespecified perioperative respiratory outcome definitions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first dose of assigned study hypnotic through postoperative day 30
All-cause mortality
Death from any cause.
Measured: Within 30 days after completion of skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duanyi, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785557
- Sponsor's protocol ID
- 27032-0-01
- Acronym
- REPAIR
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam Versus Propofol on Early Postoperative Quality of Recovery in Patients Undergoing Cytoreductive Surgery for Peritoneal Surface Malignancies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07785557
- Acronym / sponsor ID
- REPAIR / 27032-0-01
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: RemimazolamParticipants 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. |
| Propofol | Active comparator | Drug: PropofolParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1.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.
- 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 informed consent. Exclusion Criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamRemimazolam 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. | Drug | Remimazolam |
| PropofolPropofol 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. | Drug | Propofol |
Primary outcome
Quality of Recovery-15 total score at 48 hours
Time frame: 48 ± 4 hours after the end of surgery, defined as completion of skin closure (allowable window, 44 to 52 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.
24 secondary outcomes
Quality of Recovery-15 total score at 24 hours
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
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
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
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
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery
Lowest intraoperative mean arterial pressure
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Time to first vasopressor administration
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Cumulative dose of vasopressors
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Maximum vasopressor infusion rate
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.
Number of hypotension rescue episodes
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
Time frame: From initiation of the assigned study hypnotic until completion of skin closure during the index surgery
Incidence of acute kidney injury
Time frame: From completion of skin closure through postoperative day 7 or hospital discharge, whichever occurs first.
Incidence of postoperative infection
Time frame: Within 30 days after completion of skin closure
Incidence of postoperative delirium
Time frame: Postoperative days 1 to 3 or until transfer out of the ICU, whichever occurs first.
Incidence of postoperative hypoxemia
Time frame: Within 7 days after completion of skin closure
Use of noninvasive ventilation
Time frame: Within 7 days after completion of skin closure.
Use of high-flow nasal cannula oxygen
Time frame: Within 7 days after completion of skin closure
Incidence of respiratory failure
Time frame: Within 7 days after completion of skin closure
Incidence of reintubation
Time frame: Within 7 days after the first planned extubation
Incidence of pneumonia
Time frame: Within 7 days after completion of skin closure
Incidence of bradycardia
Time frame: From the first dose of assigned study hypnotic through postoperative day 30
Incidence of study-drug allergic reactions
Time frame: From the first dose of assigned study hypnotic through postoperative day 30
Incidence of serious adverse events
Time frame: From the first dose of assigned study hypnotic through postoperative day 30
All-cause mortality
Time frame: Within 30 days after completion of skin closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for Peritoneal Neoplasms
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Propofol in people with Peritoneal Neoplasms and Postoperative Recovery, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Duan, MD (+86-13810385311, dya01610@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 total score at 48 hours (time frame: 48 ± 4 hours after the end of surgery, defined as completion of skin closure (allowable window, 44 to 52 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.