Trial · NCT07912203
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
NCT07912203, Phase 4, Not yet recruiting, National Institute of Neurology, Tunisia
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia. Trials, record NCT07912203. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912203
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
- NCT number
- NCT07912203
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 60 participants, estimated
- Lead sponsor
- National Institute of Neurology, Tunisia
- Conditions
- Chronic Subdural Hematoma
- Interventions
- Dexmedetomidine, Propofol (Astra-Zeneca)
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of time within target sedation | Intraoperative, from skin incision to end of skin closure (approximately 1 hour) | Percentage of the time between skin incision and end of skin closure spent with a Richmond Agitation-Sedation Scale (RASS) score between -2 and -3 (scale range -5 \[unarousable\] to +4 \[combative\]). RASS is scored every 5 minutes; each score is assumed valid until the next one. After a sedation failure, all remaining time is counted as outside the target. |
| Secondary | Time to target sedation | From start of sedation until target sedation is first reached (up to 1 hour) | Time from the start of the sedative to the first RASS score between -2 and -3, in minutes. |
| Secondary | Surgeon and anesthesiologist satisfaction | Immediately after the end of skin closure | Satisfaction rated by the surgeon and by the anesthesiologist on a 5-point Likert scale (from very satisfied to very dissatisfied). |
| Secondary | Recovery time | From end of surgery until recovery, assessed up to 2 hours | Time from discontinuation of the sedative to a modified Aldrete score ≥ 9 (or return to baseline neurological status in patients with hemiparesis), in minutes. |
| Secondary | Incidence of respiratory adverse events | From start of sedation until discharge from the post-anesthesia care unit (up to 4 hours) | Number of patients with apnea (\> 20 s), hypoventilation (respiratory rate \< 8/min or loss of the capnography waveform), desaturation (SpO2 \< 92% for ≥ 30 s), upper airway obstruction or need for ventilatory assistance. |
| Secondary | Incidence of hemodynamic adverse events | From start of sedation until end of surgery (approximately 1 hour) | Number of patients with bradycardia (heart rate \< 50 bpm), hypotension (mean arterial pressure \< 65 mmHg or decrease \> 25% from baseline) or hypertension (systolic pressure \> 160 mmHg or increase \> 20% from baseline), and need for corrective treatment. |
| Secondary | Sedation failure rate | Intraoperative (approximately 1 hour) | Proportion of patients with efficacy failure (dose ceiling with RASS \> -2, persistent agitation, non-protocol rescue sedative) or procedural failure (conversion to general anesthesia, persistent desaturation, major hemodynamic instability). |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07912203
GET https://conductscience.org/api/trials/v1/NCT07912203/registered