NCT06139692 Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke
| NCT ID | NCT06139692 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Jinling Hospital, China |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 810 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2026-06-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 810 participants in total. It began in 2023-11-21 with a primary completion date of 2026-06-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy in acute ischemic stroke patients with large vessel occlusion in the anterior circulation.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years 2. Presenting with symptoms of acute ischemic stroke 3. CTA or MRA confirmed occlusion of the anterior circulation (intracranial carotid artery or M1, M2 segment of the middle cerebral artery) 4. Randomization finished within 24 hours of symptom onset or time last know well 5. Pre-stroke mRS score ≤2 6. NIHSS score ≥6 at the time of randomization 7. ASPECTS value ≥3 8. Informed consent signed Exclusion Criteria: General exclusion criteria 1. Pregnant or lactating women 2. Known allergy to contrast agents or nitinol devices 3. Known allergy to midazolam or other benzodiazepines 4. Known allergy to dexmedetomidine or its components 5. Planned to receive general anesthesia for EVT 6. Uncontrolled hypertension or hypotension (defined as systolic blood pressure \>185 mmHg or \< 90 mmHg, diastolic blood pressure \>110 mmHg or \< 60 mmHg) 7. Second-degree or third-degree heart blockage or bradyarrhythmia with a baseline heart rate lower than 50 beats/min 8
Frequently Asked Questions
Who can join the NCT06139692 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06139692 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06139692 currently recruiting?
Yes, NCT06139692 is actively recruiting participants. Visit ClinicalTrials.gov or contact Jinling Hospital, China to inquire about joining.
Where is the NCT06139692 trial being conducted?
This trial is being conducted at Nanjing, China, Chengdu, China.
Who is sponsoring the NCT06139692 clinical trial?
NCT06139692 is sponsored by Jinling Hospital, China. The trial plans to enroll 810 participants.
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