Trial · NCT07603596
Opioid-free Anesthesia and Postoperative Delirium
NCT07603596, Phase 1, Not yet recruiting, Qianfoshan Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Opioid-free Anesthesia and Postoperative Delirium. Trials, record NCT07603596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07603596
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Opioid-free Anesthesia and Postoperative Delirium
- NCT number
- NCT07603596
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 174 participants, estimated
- Lead sponsor
- Qianfoshan Hospital
- Conditions
- Postoperative Delirium, Gastrointestinal Tumors
- Interventions
- OFA group, OBA group
- First posted
- 2026-05-22
- Last updated
- 2026-05-22
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07603596
GET https://conductscience.org/api/trials/v1/NCT07603596/registered