Trial · NCT06096181
Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery
NCT06096181, Phase 2, Terminated, Cedars-Sinai Medical Center; results first posted 2025-11-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery. Trials, record NCT06096181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06096181
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery
- NCT number
- NCT06096181
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Cedars-Sinai Medical Center
- Conditions
- Adolescent Idiopathic Scoliosis, Multimodal Analgesia, Opioid Induced Hyperalgesia, Remifentanil, Dexmedetomidine, Posterior Spinal Fusion
- Interventions
- Remifentanil TIVA, Dexmedetomidine TIVA, Propofol TIVA
- First posted
- 2023-10-23
- Last updated
- 2025-11-10
- Results first posted
- 2025-11-10
- Limitations and caveats
The study terminated early. Motor evoked potentials (MEP) is a monitor of spinal cord integrity, used to detect and prevent new neurological deficits in the context of spine surgery. Following anecdotally observed effects of some anesthetics interfering with MEP in patients undergoing scoliosis surgery, the surgeon involved in the study decided to pause enrollment and ultimately terminate the study early out of caution for patients.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 | Post Op Day# 0 and 1 | Measure the median total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1. |
| Primary | Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 | Post Op Day# 0 and 1 | Measure the mean total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1. |
| Secondary | Mean VAS Pain Score on POD# 0 and 1 | Post Op Day# 0 and 1 | Measure the mean pain score of the participant on a visual analog pain scale. The VAS has two end points representing 0 ("no pain") and 10 ("worst pain ever"). It is reported at our institution as a number between 0 and 10. |
| Secondary | Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins) | Intraoperative (day of surgery) | Measure the median time (mins) from completion of surgical skin closure to the participant being able to move their feet to command. |
| Secondary | Time From Skin Closure to Extubation | Intraoperative (day of surgery) | Measure the median time (mins) from completion of surgical skin closure to extubation. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 | Post Op Day# 0 and 1 | MME | MEDIAN | |
| SECONDARY | Mean VAS Pain Score on POD# 0 and 1 | Post Op Day# 0 and 1 | Visual Analog Pain Scale Score | MEAN | |
| SECONDARY | Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins) | Intraoperative (day of surgery) | Minutes | MEDIAN | |
| SECONDARY | Time From Skin Closure to Extubation | Intraoperative (day of surgery) | Minutes | MEDIAN | |
| PRIMARY | Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 | Post Op Day# 0 and 1 | MME | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 | Propofol + Remifentanil | MME POD 0 | 36.30 | Inter-Quartile Range 71.90 | MME |
| Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 | Propofol + Dexmedetomidine | MME POD 0 | 70.5 | Inter-Quartile Range 66.98 | MME |
| Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 | Propofol + Remifentanil | MME POD 1 | 57.5 | Inter-Quartile Range 32.5 to 61.7 | MME |
| Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 | Propofol + Dexmedetomidine | MME POD 1 | 48 | Inter-Quartile Range 41.9 to 54.1 | MME |
| Mean VAS Pain Score on POD# 0 and 1 | Propofol + Remifentanil | VAS POD 0 | 3.39 | Standard Deviation 2.30 | Visual Analog Pain Scale Score |
| Mean VAS Pain Score on POD# 0 and 1 | Propofol + Dexmedetomidine | VAS POD 0 | 2.23 | Standard Deviation 1.40 | Visual Analog Pain Scale Score |
| Mean VAS Pain Score on POD# 0 and 1 | Propofol + Remifentanil | VAS POD 1 | 3.32 | Standard Deviation 2.81 | Visual Analog Pain Scale Score |
| Mean VAS Pain Score on POD# 0 and 1 | Propofol + Dexmedetomidine | VAS POD 1 | 3.21 | Standard Deviation 0.98 | Visual Analog Pain Scale Score |
| Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins) | Propofol + Remifentanil | 14 | Inter-Quartile Range 9 to 18 | Minutes | |
| Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins) | Propofol + Dexmedetomidine | 21.5 | Inter-Quartile Range 10 to 30.75 | Minutes |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Propofol + Remifentanil | 7 | |
| Overall Study | STARTED | Propofol + Dexmedetomidine | 6 | |
| Overall Study | COMPLETED | Propofol + Remifentanil | 7 | |
| Overall Study | COMPLETED | Propofol + Dexmedetomidine | 6 | |
| Overall Study | NOT COMPLETED | Propofol + Remifentanil | 0 | |
| Overall Study | NOT COMPLETED | Propofol + Dexmedetomidine | 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 | Propofol + Remifentanil | 0 | 7 |
| Total, all-cause mortality | Propofol + Dexmedetomidine | 0 | 6 |
| Total, other adverse events | Propofol + Remifentanil | 0 | 7 |
| Total, other adverse events | Propofol + Dexmedetomidine | 0 | 6 |
| Total, serious adverse events | Propofol + Remifentanil | 0 | 7 |
| Total, serious adverse events | Propofol + Dexmedetomidine | 0 | 6 |
Source ClinicalTrials.gov
Papers39
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Propofol + Remifentanil vs Propofol + Dexmedetomidine: deaths from any cause | Trial comparisons |
| Propofol + Remifentanil vs Propofol + Dexmedetomidine: 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/NCT06096181
GET https://conductscience.org/api/trials/v1/NCT06096181/papers?page=2