Trial · NCT07603596
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of postoperative delirium (POD) within 7 days after surgery or at discharge | 7 days after surgery or at discharge | |
| Secondary | All-cause mortality within 30 days after surgery | 30 days after surgery | |
| Secondary | Serum tumour necrosis factor-α (TNF-α, pg/mL) concentration | 10 minutes after anaesthesia induction; 10 minutes and 1 hour after pneumoperitoneum; and 24 hours and 48 hours after surgery | Blood samples are collected at 5 predefined perioperative time points: 10 minutes after anaesthesia induction (baseline), 10 minutes after pneumoperitoneum, 1 hour after pneumoperitoneum, 24 hours post-surgery, and 48 hours post-surgery. Serum TNF-α concentration is measured in duplicate by enzyme-linked immunosorbent assay (ELISA). Each time point yields a separate value; these values are not aggregated into a single composite measure. All five time-specific values will be analysed separately using repeated measures models to compare changes over time between the two treatment groups. |
| Secondary | Serum cortisol concentration (nmol/L) | 10 minutes after anaesthesia induction; 10 minutes and 1 hour after pneumoperitoneum; and 24 hours and 48 hours after surgery | |
| Secondary | Quality of Recovery-15 (QoR-15) score | 24 hours, 48 hours, and 72 hours after surgery | The QoR-15 is a 15-item patient-reported questionnaire that measures quality of recovery after surgery and anesthesia. Each item is scored from 0 (none of the time) to 10 (all of the time). Total scores range from 0 (worst possible recovery) to 150 (best possible recovery). Higher scores indicate a better outcome. |
| Secondary | Postoperative complications during hospitalization | During the index hospitalization, from the end of surgery until hospital discharge (assessed daily; reported for the entire hospitalization period) Alternative specific phrasing: "Up to 30 days" if discharge may occur earlier. | Postoperative complications are defined according to \[specify criteria, e.g., Clavien-Dindo classification, or list specific complications such as surgical site infection, pneumonia, deep vein thrombosis, etc.\]. The number of participants experiencing one or more complications during the specified time frame will be reported. No scale is used; this is a binary (yes/no) outcome per participant. |
| Secondary | Numeric Rating Scale (NRS) Pain Score | Day 1 (day of surgery, assessed within 6 hours after arrival to the post-anaesthesia care unit) Day 2 (postoperative day 2, assessed at 48 ± 6 hours after surgery) Day 3 (postoperative day 3, assessed at 72 ± 6 hours after surgery) | Pain intensity is assessed using the 11-point Numeric Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. The assessment is performed at rest and on movement (e.g., coughing or deep breathing) by a trained research assistant blinded to group allocation. The score at 72 hours post-surgery (with an allowable window of 72 ± 6 hours) is recorded as the primary pain outcome. If the 72-hour assessment coincides with hospital discharge before that time point, the assessment is performed at discharge (up to 72 hours). The single score at this specified time point is reported; no aggregation across multiple time points is performed. |
| Secondary | Incidence and Severity of Postoperative Nausea and Vomiting (PONV) as Assessed by a 4-Point Categorical Scale | From the end of surgery up to 72 hours postoperatively | PONV is measured using a 4-point categorical scale: 0 = no nausea or vomiting 1. = mild nausea without vomiting 2. = moderate nausea with retching or one episode of vomiting 3. = severe nausea with multiple episodes of vomiting Minimum value = 0, maximum value = 3. Higher scores indicate a worse outcome (more severe PONV). The primary metrics reported will be: Incidence = proportion of participants with any PONV (score ≥1) during the time frame Severity = mean (or median) score at each time point, plus the proportion with a score of 3 |
| Secondary | Total Postoperative Opioid Consumption in Morphine Milligram Equivalents (MME) | From the end of surgery up to 72 hours postoperatively | All opioid analgesics administered intravenously, orally, or via patient-controlled analgesia (PCA) during the specified time frame are converted to MME using standard conversion factors (e.g., CDC or equianalgesic reference). Minimum value = 0 MME (no opioid use) Maximum value = no theoretical upper limit (reported as range observed) Higher MME indicates greater opioid consumption, which is generally considered a worse outcome (e.g., more pain or greater analgesic requirement) The primary metric reported will be mean (or median) total MME per participant during the time frame, along with standard deviation or interquartile range. |
| Secondary | Duration of anaesthesia (in minutes) | during anaesthesia | Duration of anaesthesia is defined as the time from the start of anaesthesia induction (first administration of induction agent) to the withdrawal of all anaesthetic maintenance medications at the end of surgery. The duration is recorded in minutes and calculated from intraoperative anaesthesia records. A single value is reported per participant. |
| Secondary | Operation time (in minutes) | from skin incision to the last suture | |
| Secondary | Length of PACU stay (in minutes) | From PACU admission (immediately after surgery) to PACU discharge, assessed at the time of discharge. | |
| Secondary | Length of Hospital Stay (days) | From the date of hospital admission to the date of hospital discharge, assessed through hospital discharge (average expected stay of 7 days). | Length of stay is calculated as the total number of calendar days from admission (or surgery) to discharge. If discharge occurs on the same day as admission/surgery, length of stay is recorded as 0 days. This is a continuous outcome measure; shorter length of stay is generally considered a better outcome (indicating faster recovery and fewer complications). The primary metric reported will be the mean (or median) length of stay in days, with standard deviation or interquartile range. |
| Secondary | Intraoperative Systolic Blood Pressure (SBP， mmHg) | before intubation, immediately after intubation, at incision, at 30 min (±5 min) after pneumoperitoneum, at 60 min (±5 min) after pneumoperitoneum, at 120 min (±5 min) after pneumoperitoneum, at 5 min before end of surgery, and at extubation. | Systolic blood pressure (SBP) is recorded in mmHg from the anaesthesia information management system (invasive arterial line or non-invasive cuff as per clinical routine) at each of the 8 specified time points. Each time point yields a separate absolute value. No aggregation (e.g., average, area under the curve) is performed across time points. The 8 time-specific values will be analysed separately using repeated measures models to compare changes between treatment groups. |
| Secondary | Intraoperative Diastolic Blood Pressure (DBP, mmHg) | before intubation, immediately after intubation, at incision, at 30 min (±5 min) after pneumoperitoneum, at 60 min (±5 min) after pneumoperitoneum, at 120 min (±5 min) after pneumoperitoneum, at 5 min before end of surgery, and at extubation. | Diastolic blood pressure (DBP) is recorded in mmHg at each of the 8 specified time points. Each time point provides an independent absolute value. No aggregation across time points is performed. The eight values will be analysed using repeated measures methods. |
| Secondary | Intraoperative Mean Arterial Pressure (MAP, mmHg) | before intubation, immediately after intubation, at incision, at 30 min (±5 min) after pneumoperitoneum, at 60 min (±5 min) after pneumoperitoneum, at 120 min (±5 min) after pneumoperitoneum, at 5 min before end of surgery, and at extubation. | Mean arterial pressure (MAP) is recorded in mmHg at the 8 specified time points (either directly measured from an arterial line or calculated as (SBP + 2×DBP)/3 if non-invasive cuff is used). Values are reported separately for each time point; no composite summary measure is created. Repeated measures analysis will compare MAP trajectories between the two randomised groups. |
| Secondary | Intraoperative Heart Rate (HR, bpm) | before intubation, immediately after intubation, at incision, at 30 min (±5 min) after pneumoperitoneum, at 60 min (±5 min) after pneumoperitoneum, at 120 min (±5 min) after pneumoperitoneum, at 5 min before end of surgery, and at extubation. | Heart rate (HR) is recorded in beats per minute from continuous ECG monitoring at each of the 8 specified time points. Each time point yields a separate absolute value. No aggregation across time points is performed. The eight time-specific HR values will be analysed using repeated measures models to assess group differences and time-by-group interactions. |
| Secondary | Serum interleukin-6 (IL-6, pg/mL) concentration | 10 minutes after anaesthesia induction; 10 minutes and 1 hour after pneumoperitoneum; and 24 hours and 48 hours after surgery | Blood samples are collected at the same 5 perioperative time points as described for TNF-α (baseline, 10 min after pneumoperitoneum, 1 h after pneumoperitoneum, 24 h post-surgery, 48 h post-surgery). |
| Secondary | Serum epinephrine concentration (pg/mL) | 10 minutes after anaesthesia induction; 10 minutes and 1 hour after pneumoperitoneum; and 24 hours and 48 hours after surgery | |
| Secondary | Serum norepinephrine concentration (pg/mL) | 10 minutes after anaesthesia induction; 10 minutes and 1 hour after pneumoperitoneum; and 24 hours and 48 hours after surgery |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07603596/registered