| CTRI Number |
CTRI/2026/03/106011 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
“Effect of Different Anaesthesia Methods on Surgical Outcomes in Polytrauma Patients Undergoing Vascular Repair |
|
Scientific Title of Study
|
THE EFFECT OF ANAESTHESIA TECHNIQUE ON PERIOPERATIVE OUTCOME FOLLOWING VASCULAR REPAIR SURGERY ASSOCIATED WITH POLYTRAUMA |
| Trial Acronym |
IEC-INT/2026/MSc-3378 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NARESH KUMAR |
| Designation |
TECHNICIAN OT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA
Chandigarh CHANDIGARH 160012 India |
| Phone |
09814869994 |
| Fax |
|
| Email |
nareshkg85@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amar Jyoti Hazarika |
| Designation |
Additional professor |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH
Chandigarh CHANDIGARH 160012 India |
| Phone |
70870087521 |
| Fax |
|
| Email |
amarjyoti28@rediffmai.com |
|
Details of Contact Person Public Query
|
| Name |
NARESH KUMAR |
| Designation |
TECHNICIAN OT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA
Chandigarh CHANDIGARH 160012 India |
| Phone |
09814869994 |
| Fax |
|
| Email |
nareshkg85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
PGIMER CHANDIGARH SECTOR 12 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER |
PGIMER CHANDIGARH SECTOR 12 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amarjyoti hazarika |
PGIMER chandigarh |
DEPARTMENT OF ANAESTHESIA ATC PGIMER CHANDIGARH Chandigarh CHANDIGARH |
7087008752
amarjyoti28@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V899||Person injured in unspecified vehicle accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Study Setting
A) Study Area
The study will be carried out at the Advanced Trauma Centre, Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh.
B) Study Population
The study population will consist of adult polytrauma patients presenting with extremity vascular injuries requiring surgical repair, who meet the defined eligibility criteria and receive either total intravenous anaesthesia (TIVA) or titrated inhalational anaesthesia (TIA) during the procedure. All consecutive eligible patients admitted over the one-year study period will be included
Inclusion Criteria
Patients of age 18–65 years with polytrauma, requiring emergency/urgent extremity vascular repair, receiving TIVA or TIA as the primary anaesthetic technique
Patients giving consent to participate in the study
Patients who have been cleared for surgery after neurosurgery re
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Severe traumatic brain injury
Patient not cleared from neurosurgery
Preoperative cardiac arrest
Documented allergy to anaesthetic drugs
Pregnant patient
Patient refusal
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of amputation between TIVA and TIA following vascular surgery associated with orthopedic fracture |
1 base line
2 After 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the incidence of limb amputation in relation to the anatomical location of the fracture.
To evaluate the type of vascular involvement (arterial or venous) associated with cases resulting in amputation.
|
1 base line
2 After 28 days follow up |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nareshkg85@gmail.com].
- For how long will this data be available start date provided 20-02-2026 and end date provided 30-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO
|
|
Brief Summary
|
Robinson et al. investigated the vascular effects of propofol and demonstrated that its peripheral vasodilatory action is largely mediated through suppression of sympathetic vasoconstrictor nerve activity(22). This mechanism results in a reduction of vascular tone and subsequent vasodilatation. In the context of vascular injury, such pharmacological properties of propofol may be advantageous in mitigating elevated vascular tone and supporting adequate postoperative blood flow(22). Volatile anaesthetics allow rapid titration and can be advantageous during phases of physiological instability commonly encountered in polytrauma (23). Studies have also found that inhalation anaesthetics cause vascular dilatation, too, more so by sevoflurane compared to isoflurane (24). This could be again beneficial in managing vascular injury where tone is increased. This will help to enhance blood flow. However, evidence specifically analysing anaesthesia type in orthopedic vascular trauma is scarce. Evidence specific to orthopedic–vascular trauma remains limited; hence, anaesthetic strategies are typically individualized based on patient physiology, anticipated blood loss, injury severity, and the staged nature of damage-control surgery. Kampman et al. conducted a large multinational meta-analysis involving over 51,000 patients, found no significant differences in all-cause mortality, myocardial infarction, stroke, or major postoperative complications between TIVA and inhalational anaesthesia (25). Choi et al., in a randomised trial conducted in an orthopaedic arthroplasty centre, reported no significant differences between TIVA and volatile anaesthesia in postoperative pain scores or opioid requirements in patients undergoing total shoulder arthroplasty (26). Yin et al., in an arthroscopy-focused orthopaedic centre, concluded that both TIVA and sevoflurane provided acceptable operative field visibility and comparable surgical quality during shoulder arthroscopy (27). |