Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)

December 19, 2023 updated by: Changwei Wei, Beijing Chao Yang Hospital

Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)

Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion.

Dexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ischemic stroke.

Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury.

The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.

Study Type

Interventional

Enrollment (Estimated)

368

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 2≤NIHSS≤25
  • mRS score before stroke was less than 3
  • Acute ischemic stroke (including anterior circulation)
  • mTICI rate 2b or 3
  • According to the 2018 AHA/ASA guidelines for the management of acute ischemic stroke, patients who plan to receive mechanical thrombectomy under local anesthesia and sedation
  • Informed consent was signed by patient or legal representative

Exclusion Criteria:

  • Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks
  • Patients who had received stent treatment at the responsible vessel in the past
  • Neurological function was restored at or before angiography
  • Patients who are allergic to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, poly (n-butyl methacrylate), stainless steel, anesthetics and contrast agents or have contraindications
  • Hemoglobin was less than 70g/L, platelet count was less than 50×109/L, international normalized ratio (INR) greater than 1.5 (irreversible), there are uncorrectable bleeding factors
  • Blood glucose < 2.7 mmol/L or > 22.2 mmol/L
  • Severe liver or kidney disfunction, ALT>3 times the upper limit of normal value or AST>3 times the upper limit of normal value, creatinine>1.5 times the upper limit of normal value
  • Pregnant or lactating women
  • Previous history of mental illness
  • Stroke with other acute diseases or postoperative stroke of other operation
  • Heart rate less than 50bpm, second or third degree of atrioventricular block (except for pacemaker implantation), systolic blood pressure less than 90mmHg (two vasoactive drugs were already infused continuously )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Dexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3.
Drug: Dexmedetomidine prolonged sedation
Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.
Placebo Comparator: Control group
An equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3.
Drug: 0.9% saline
An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The favorable functional outcome of stroke-related disability rate
Time Frame: 90 ± 14 days after thrombectomy
Modified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.
90 ± 14 days after thrombectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: From the date of admission until discharged from ICU, up to 30 days
Length of ICU stay
From the date of admission until discharged from ICU, up to 30 days
Length of hospital stay
Time Frame: From the date of admission until discharged from hospital, up to 30 days
Length of hospital stay
From the date of admission until discharged from hospital, up to 30 days
Changes of National Institute of Health stroke scale
Time Frame: 24 ± 6 hours after thrombectomy
NIHSS (admission) - NIHSS (24h)
24 ± 6 hours after thrombectomy
Changes of ischemic penumbra
Time Frame: on the 7-day or discharged day whichever comes first, up to 30 days
The difference of infarct volume between preoperative and 7-day or discharged day
on the 7-day or discharged day whichever comes first, up to 30 days
adverse events at 90-day after operation
Time Frame: within 90-day after thrombectomy
hypotension (systolic blood pressure under 90mmHg), bradycardia (heart rate under 50bpm), hypoxemia (pulse oxygen saturation under 90%), and serious events such as death and life-threatening events
within 90-day after thrombectomy
mortality rate at 90-day after operation
Time Frame: within 90-day after thrombectomy
Death after thrombectomy within 90-day after operation
within 90-day after thrombectomy
Changes of National Institute of Health stroke scale
Time Frame: on the 7-day or discharged day whichever comes first, up to 30 days
NIHSS (admission) - NIHSS (7day)
on the 7-day or discharged day whichever comes first, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00375929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol and Informed Consent Form will be shared with other researchers.

IPD Sharing Time Frame

The information will become available after the publishing of this study and will be available for 1-year after publishing.

IPD Sharing Access Criteria

Please contact by E-mail at thoth_safin@sina.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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