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

NCT04916197 | Recruiting Phase 4

• 1 other identifier: 00375929
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Endovascular thrombectomy; Dexmedetomidine; Modified Rankin Scale

Outcome Measures

Primary Outcomes (1)

• The favorable functional outcome of stroke-related disability rate

  Modified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.

  90 ± 14 days after thrombectomy

Secondary Outcomes (7)

• Changes of National Institute of Health stroke scale

  24 ± 6 hours after thrombectomy

• Changes of National Institute of Health stroke scale

  on the 7-day or discharged day whichever comes first, up to 30 days

• Changes of ischemic penumbra

  on the 7-day or discharged day whichever comes first, 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

  From the date of admission until discharged from hospital, up to 30 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Dexmedetomidine prolonged sedation DRUG

Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.

Intervention group

0.9% saline DRUG

An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing ChaoYang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related Publications (1)

• Yang LN, Sun Y, Wang YZ, Wang J, Qi YS, Mu SS, Liu YP, Zhang ZQ, Chen ZM, Wang XJ, Xie WX, Wei CW, Wang Y, Wu AS. Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial. Trials. 2024 Mar 4;25(1):166. doi: 10.1186/s13063-024-08015-x.

  PMID: 38439027 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Lina Yang

CONTACT

18611635556; Thoth_safin@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 7, 2021
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The information will become available after the publishing of this study and will be available for 1-year after publishing.
• Access Criteria: Please contact by E-mail at thoth\ safin@sina.com

Locations

CN (1)