Trial · NCT07337135
Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery
NCT07337135, Not applicable, Completed, Hospital dos Lusíadas; results first posted 2026-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery. Trials, record NCT07337135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07337135
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery
- NCT number
- NCT07337135
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 60 participants, actual
- Lead sponsor
- Hospital dos Lusíadas
- Conditions
- Morbid Obesity, Postoperative Pain, Opioid Free Anesthesia, Bariatric Surgery
- Interventions
- Opioid-Based Anesthesia (Remifentanil-Based Protocol), Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol)
- First posted
- 2026-01-13
- Last updated
- 2026-02-25
- Results first posted
- 2026-02-25
- Limitations and caveats
This study was conducted at a single center with a relatively small sample size, which may limit the generalizability of the findings. The trial was retrospectively registered, and some intraoperative measurements (NOL index) were available only for a subset of participants, with the number of observations varying across time points due to differences in surgical duration. Differences in antiemetic prophylaxis between groups may also have influenced postoperative nausea and vomiting outcomes.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Time Frame: - Within 30 minutes of arrival at the Post-Anesthesia Care Unit (PACU); - At PACU discharge (assessed up to 2 hours after PACU admission); - Within the first 24 postoperative hours; - 48 hours postoperatively (at hospital discharge). | Postoperative pain will be assessed using the Numerical Rating Scale for Pain (NRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate a worse outcome, reflecting greater pain intensity. Pain intensity will be compared between the opioid-free anesthesia group and the opioid-based anesthesia group at predefined postoperative time points. |
| Secondary | Intraoperative Nociception (NOL Index) | Multiple standardized time points during surgery (15 to 180 minutes) | Nociception will be assessed using the NOL (Nociception Level) Index, a multiparametric autonomic signal-based monitor. Lower values reflect better nociceptive control. Comparisons will be made between OFA and OBA groups at all recorded time points. |
| Secondary | Need for Rescue Analgesia | - During PACU stay (assessed up to 2 hours after PACU admission). | The proportion of patients requiring rescue analgesia (tramadol and/or morphine) will be compared between the opioid-free anesthesia group and the opioid-based anesthesia group. |
| Secondary | Opioid Consumption | - During PACU stay (assessed up to 2 hours after PACU admission). | Need for opioid administration as rescue analgesia will be recorded and compared between groups. |
| Secondary | Incidence of Postoperative Nausea and Vomiting (PONV) | At 6 hours and 24 hours after surgery | PONV will be assessed using the Postoperative Nausea and Vomiting Impact Scale, comparing frequency and severity between groups. The total score ranges from 0 (no nausea or vomiting) to 6 (maximum impact). Higher scores indicate a worse outcome, reflecting greater severity and clinical impact of postoperative nausea and vomiting. |
| Secondary | Need for PONV Treatment | First 24 postoperative hours | Proportion of patients requiring antiemetic treatment will be evaluated and compared. |
| Secondary | Patient Satisfaction | 48 hours postoperatively (at hospital discharge). | Patient satisfaction will be assessed using a Numerical Satisfaction Rating Scale and compared between groups. Total score ranges from 1 (minimum satisfaction) to 10 (maximum satisfaction). Higher scores indicate a better outcome, reflecting greater patient satisfaction. |
| Secondary | Postoperative Complications | Periprocedurally, up to 48 hours postoperatively. | Occurrence of perioperative complications (respiratory, cardiovascular, surgical, or anesthesia-related) will be recorded. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Time Frame: - Within 30 minutes of arrival at the Post-Anesthesia Care Unit (PACU); - At PACU discharge (assessed up to 2 hours after PACU admission); - Within the first 24 postoperative hours; - 48 hours postoperatively (at hospital discharge). | All randomized participants were included in the analysis of postoperative pain intensity. Pain assessments were available for all participants at the predefined time points, and no participants were excluded from this outcome analysis. | Score on a scale (0-10) | MEDIAN |
| SECONDARY | Intraoperative Nociception (NOL Index) | Multiple standardized time points during surgery (15 to 180 minutes) | Intraoperative NOL measurements were available only for a subset of participants. The number of participants contributing data at each time point varied due to differences in surgical duration, as later time points were reached only by longer procedures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Need for Rescue Analgesia | - During PACU stay (assessed up to 2 hours after PACU admission). | All randomized participants were included in the analysis of rescue analgesia requirements. Data on the need for rescue analgesia were available for all participants, and no participants were excluded from this outcome analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Opioid Consumption | - During PACU stay (assessed up to 2 hours after PACU admission). | The analysis of opioid use included only participants who required rescue analgesia during the PACU stay (assessed up to 2 hours after PACU admission). Among these participants, opioid administration was recorded. Participants who did not require rescue analgesia were not included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Postoperative Nausea and Vomiting (PONV) | At 6 hours and 24 hours after surgery | All randomized participants were included in the analysis of postoperative nausea and vomiting. PONV data were available for all participants at the predefined postoperative time points, and no participants were excluded from this outcome analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Need for PONV Treatment | First 24 postoperative hours | All randomized participants were included in the analysis of the need for treatment of postoperative nausea and vomiting. Data were available for all participants, and no participants were excluded from this outcome analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Satisfaction | 48 hours postoperatively (at hospital discharge). | All randomized participants were included in the analysis of patient satisfaction. Satisfaction scores were available for all participants at hospital discharge, and no participants were excluded from this outcome analysis. | Score on a scale (1-10) | MEAN |
| SECONDARY | Postoperative Complications | Periprocedurally, up to 48 hours postoperatively. | All randomized participants were included in the analysis of postoperative complications. Data were available for all participants during the hospital stay, and no participants were excluded from this outcome analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Opioid-Based Anesthesia (OBA) | Within 30 minutes of arrival at the Post-Anesthesia Care Unit (PACU) | 2.5 | Inter-Quartile Range 0 to 5.5 | Score on a scale (0-10) |
| Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Opioid-Free Anesthesia (OFA) | Within 30 minutes of arrival at the Post-Anesthesia Care Unit (PACU) | 0 | Inter-Quartile Range 0 to 2 | Score on a scale (0-10) |
| Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Opioid-Based Anesthesia (OBA) | At PACU discharge (assessed up to 2 hours after PACU admission) | 3 | Inter-Quartile Range 1 to 5 | Score on a scale (0-10) |
| Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Opioid-Free Anesthesia (OFA) | At PACU discharge (assessed up to 2 hours after PACU admission) | 1 | Inter-Quartile Range 0 to 3 | Score on a scale (0-10) |
| Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Opioid-Based Anesthesia (OBA) | Within the first 24 postoperative hours; | 3 | Inter-Quartile Range 2 to 4 | Score on a scale (0-10) |
| Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Opioid-Free Anesthesia (OFA) | Within the first 24 postoperative hours; | 1 | Inter-Quartile Range 0 to 3 | Score on a scale (0-10) |
| Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Opioid-Based Anesthesia (OBA) | 48 hours postoperatively (at hospital discharge) | 0 | Inter-Quartile Range 0 to 2 | Score on a scale (0-10) |
| Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) | Opioid-Free Anesthesia (OFA) | 48 hours postoperatively (at hospital discharge) | 0 | Inter-Quartile Range 0 to 0 | Score on a scale (0-10) |
| Intraoperative Nociception (NOL Index) | Opioid-Based Anesthesia (OBA) | NOL index at 15 minutes: <10 | 5 | Participants | |
| Intraoperative Nociception (NOL Index) | Opioid-Free Anesthesia (OFA) | NOL index at 15 minutes: <10 | 11 | Participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Opioid-Free Anesthesia (OFA) | 30 | |
| Overall Study | STARTED | Opioid-Based Anesthesia (OBA) | 30 | |
| Overall Study | COMPLETED | Opioid-Free Anesthesia (OFA) | 30 | |
| Overall Study | COMPLETED | Opioid-Based Anesthesia (OBA) | 30 | |
| Overall Study | NOT COMPLETED | Opioid-Free Anesthesia (OFA) | 0 | |
| Overall Study | NOT COMPLETED | Opioid-Based Anesthesia (OBA) | 0 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Opioid-Free Anesthesia (OFA) | 0 | 30 |
| Total, all-cause mortality | Opioid-Based Anesthesia (OBA) | 0 | 30 |
| Total, other adverse events | Opioid-Free Anesthesia (OFA) | 0 | 30 |
| Total, other adverse events | Opioid-Based Anesthesia (OBA) | 0 | 30 |
| Total, serious adverse events | Opioid-Free Anesthesia (OFA) | 0 | 30 |
| Total, serious adverse events | Opioid-Based Anesthesia (OBA) | 0 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42185786 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Opioid-Free Anesthesia (OFA) vs Opioid-Based Anesthesia (OBA): deaths from any cause | Trial comparisons |
| Opioid-Free Anesthesia (OFA) vs Opioid-Based Anesthesia (OBA): serious adverse events | Trial comparisons |
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/NCT07337135
GET https://conductscience.org/api/trials/v1/NCT07337135/results?page=2