| CTRI Number |
CTRI/2023/12/060792 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess benefit of propranolol in severely head injured patients when on ventilator. |
|
Scientific Title of Study
|
Use of beta blocker in severely head injured patients receiving mechanical ventilation in trauma intensive care: A prospective randomized double-blind study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANKITA GOYAL |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Sciences and Research, Chandigarh |
| Address |
Department of Anesthesia and Intensive Care, Nehru Building, Level 4, Sector 12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09878893034 |
| Fax |
|
| Email |
ankita25goyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nidhi Bhatia |
| Designation |
PROFESSOR |
| Affiliation |
Post Graduate Institute of Medical Sciences and Research, Chandigarh |
| Address |
Department of Anesthesia and Intensive Care, Nehru Building, Level 4, Sector 12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914207483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANKITA GOYAL |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Sciences and Research, Chandigarh |
| Address |
Department of Anesthesia and Intensive Care, Nehru Building, Level 4, Sector 12, PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
09878893034 |
| Fax |
|
| Email |
ankita25goyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departmental Thesis Funding, Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Goyal |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Trauma Intensive Care Unit, Advanced Trauma Centre, Level 3, Sector 12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
09878893034
ankita25goyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S060||Concussion, (2) ICD-10 Condition: S062||Diffuse traumatic brain injury, (3) ICD-10 Condition: S064||Epidural hemorrhage, (4) ICD-10 Condition: S063||Focal traumatic brain injury, (5) ICD-10 Condition: S068||Other specified intracranial injuries, (6) ICD-10 Condition: S061||Traumatic cerebral edema, (7) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, (8) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (9) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
20 mg of oral propranolol every 12 hourly for 3 days following ICU admission |
| Comparator Agent |
Group 2 |
placebo every 12 hourly for 3 days following ICU admission |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
â— Adult patients 18-65 years of age, with severe TBI (Glasgow Coma Scale < 8) admitted to Intensive Care Unit within 48 hours of injury
â— Admitted to Trauma Intensive Care Unit (ICU) for mechanical ventilatory support and conservative management
|
|
| ExclusionCriteria |
| Details |
Age <18 and >65years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Transcranial doppler assessed cerebral perfusion pressure changes |
Day 1 to 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in cerebral hemodynamics evaluated using Transcranial Doppler at pre-specified time intervals
2. Serum catecholamine levels at baseline and 72 hours of admission to ICU
3. Bedside Optic Nerve Sheath Diameter at pre-specified time intervals
4. Length of ICU and hospital stay
5. Incidence of neurological worsening
6. 30-day mortality outcome
7. Functional status at 3 months following discharge using the Glasgow Outcome Scale-Extended (GOS-E) |
Day 1, 2, 3, 30 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/12/2023 |
| Date of Study Completion (India) |
28/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Traumatic
brain injury (TBI) is defined as functional brain disturbance or pathological
sign of blunt or severe head injury. Neurological
dysfunction following TBI depends on the extent and volume of tissue injury.
This depends on the primary brain injury, which results from mechanical trauma
at the time of initial insult, and secondary brain injury, which refers to the
further tissue and cellular damage evolving over a period of time (from hours
to days) following the initial primary insult. Catecholamine surge that occurs following TBI is one of the reasons of secondary brain injury as its levels increase in proportion to the severity
of TBI. This increase in catecholamines has a significant impact on long-term
outcomes, both on morbidity and mortality. The systemic consequences of
elevated catecholamine levels following both generalized trauma and traumatic/non-traumatic
brain injury have been documented concerning the cardiac, pulmonary, endocrine,
and immune systems, though their effects on the brain remain less
well-understood. Propranolol
is among the frequently employed beta blockers in this context as it is
hypothesized that the neuroprotective benefits of propranolol results from
enhanced cerebral perfusion pressures, reduced cerebral hypoxia, and the decreased
catabolism and oxygen consumption during adrenergic crisis. We
have thus planned this study with the aim of evaluating the effect of beta
blocker therapy on cerebral hemodynamics following TBI using transcranial doppler. We hypothesize that
improved function outcome seen following beta-blockers in patients with severe
TBI is due to improved cerebral perfusion pressure by reduced action of
catecholamine. |