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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  
NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nareshkg85@gmail.com].

  6. 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.

  7. 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).

 
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