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Stellate Block Versus Nimodipine Infusion for Traumatic Brain Injury

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05182619
Collaborator
(none)
60
Enrollment
2
Arms
14.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

the study is designed to perform an intervention for enhancement of cerebral blood flow in patients with traumatic brain injury showing vasospasm through transcranial doppler

Condition or Disease Intervention/Treatment Phase
  • Procedure: ultrasound-guided stellate ganglion block
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Ultrasound-guided Stellate Ganglion Block Versus Nimodipine Infusion for Enhancement of Cerebral Blood Flow in Traumatic Brain Injury
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ultrasoung guided stellate block

stellate ganglion will have ultrasound-guided block via bupivacaine for sympathectomy and enhancement of cerebral blood flow

Procedure: ultrasound-guided stellate ganglion block
under aseptic conditions, using the ultrasound guidance, bilateral stellate ganglion block will be done using bupivacaine and betamethasone mixture, 8 ml volume will be given for each side
Active Comparator: nimodipine infusion

intravenous nimodipine will be given for enhancement of cerebral blood flow

Procedure: ultrasound-guided stellate ganglion block
under aseptic conditions, using the ultrasound guidance, bilateral stellate ganglion block will be done using bupivacaine and betamethasone mixture, 8 ml volume will be given for each side

Outcome Measures

Primary Outcome Measures

  1. enhancement of cerebral blood flow [one week]

    increased blood flow through middle cerebral artery and basilar artery measured by transcranial doppler ultraound

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients more than 18 ys old with isolated head trauma and traumatic brain injury
Exclusion Criteria:

  • • Hemodynamic instability (mean ABP less than 70 mmHg)

  • History of severe systemic disease including cardiopulmonary failure or hepatorenal failure

  • Allergy to local anesthetics

  • Coagulation disorders

  • Abnormal neck structures disturbing normal anatomy as neck tumors

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khaled Mohamed Abdelaal, assistant lecturer os anesthesia and intensive care, Sohag University
ClinicalTrials.gov Identifier:
NCT05182619
Other Study ID Numbers:
  • soh-Med-21-12-19
First Posted:
Jan 10, 2022
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries

Study Results

No Results Posted as of Jan 10, 2022