Health TrialsbyHealthPanel

Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Presenting with symptoms of acute ischemic stroke

CTA or MRA confirmed occlusion of the anterior circulation (intracranial carotid artery or M1, M2 segment of the middle cerebral artery)

Randomization finished within 24 hours of symptom onset or time last know well

Disqualifiers

Pregnant or lactating women

Known allergy to contrast agents or nitinol devices

Known allergy to midazolam or other benzodiazepines

Known allergy to dexmedetomidine or its components

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Patients receive perioperative sedation with dexmedetomidine

  • Midazolam

    Drug

    Patients receive perioperative sedation with midazolam

Treatment groups

810 Participants
are divided into 2 treatment groups
Group A: the dexmedetomidine groupExperimental treatment 1 intervention
Group B: the midazolam groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of mRS score 0-2 at 90 days

mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

Time frame
90 days after randomization

Secondary outcomes

1

Shift in the distribution of mRS scores at 90 days

mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

Time frame
90 days after randomization
2

The proportion of mRS score 0-1 at 90 days

mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

Time frame
90 days after randomization
3

The proportion of mRS score 0-3 at 90 days

mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

Time frame
90 days after randomization
4

Rates of successful recanalization

Successful recanalization is defined as mTICI≥2b. mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).

Time frame
Immediately after the thrombectomy procedure is completed

Other outcomes

1

Rates of symptomatic intracranial hemorrhage at 48 hours

Clinical safety endpoint. Intracranial hemorrhage within 48 hours on CT/MRI according to Heidelberg bleeding classification.

Time frame
48 hours after randomization
2

Rates of procedure-related complications

Clinical safety endpoint

Time frame
within 90 days from randomization
3

Rates of mortality at 90 days

Clinical safety endpoint

Time frame
within 90 days from randomization
4

Rates of adverse events

Clinical safety endpoint

Time frame
within 90 days from randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinling Hospital, China

Lead sponsor

Source ClinicalTrials.gov
Apply now