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CTRI Number  CTRI/2024/02/062834 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The Comparison of Total Intravenous Anaesthesia versus Inhalational Anaesthesia during spine surgery 
Scientific Title of Study   Comparison of Total Intravenous Anaesthesia (TIVA)versus Inhalational Anaesthesia during elective spine surgery –A randomized controlled 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  Prekshit onkar gudadhe 
Designation  PGJR(Anaesthesiolog) 
Affiliation  All India Institute Of Medical Sciences, Raipur 
Address  Department of Anaesthesiology All India Institute Of Medical Sciences, Raipur, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur

Raipur
CHHATTISGARH
492010
India 
Phone  9975714219  
Fax    
Email  prekshitgudadhe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rashmi dubey 
Designation  Additional professor 
Affiliation  All India Institute Of Medical Sciences, Raipur 
Address  Department of Anaesthesiology All India Institute Of Medical Sciences, Raipur, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur

Raipur
CHHATTISGARH
492010
India 
Phone  8839829867  
Fax    
Email  rashmidubey1993@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prekshit onkar gudadhe 
Designation  PGJR(Anaesthesiolog) 
Affiliation  All India Institute Of Medical Sciences, Raipur 
Address  Department of Anaesthesiology All India Institute Of Medical Sciences, Raipur, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur

Raipur
CHHATTISGARH
492010
India 
Phone  9975714219  
Fax    
Email  prekshitgudadhe@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science,Raipur  
 
Primary Sponsor  
Name  AIIMS raipur 
Address  All India Institute Of Medical Sciences, Raipur, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prekshit onkar gudadhe  All India Institute Of Medical Sciences, Raipur  All India Institute Of Medical Sciences,A block OT 4TH Floor Raipur, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur
Raipur
CHHATTISGARH 
9975714219

prekshitgudadhe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe Aiims raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M45-M49||Spondylopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Total Intravenous Anaesthesia (TIVA)Anaesthesia during elective spine surgery  Group I-Patients who will receive Inhalation group- sevoflurane anaesthesia Group II-Patients who will receive TIVA-propofol TCI infusion in combination with Fentanyl Infusuion. Duration of study - 18 months 
Comparator Agent  Inhalational Anaesthesia during elective spine surgery  Group II-Patients who will receive TIVA-propofol TCI infusion in combination with Fentanyl Infusuion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
Patients undergoing elective spine surgery
American Society of Anesthesiologists (ASA) physical status 1 and 2
 
 
ExclusionCriteria 
Details  Patient’s refusal
History of Drug Allergy
There was difficulty in the assessment of postoperative pain postoperative mechanical ventilation

Uncontrolled hypertension or diabetes mellitus Chronic obstructive pulmonary disease Hepatic and renal dysfunction
Pregnancy OR Lactation
When the patients required a second operation.
BMI more than 35 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare recovery from anesthesia assessed by time to response to eye opening in minutes , time to obey verbal commands, time to extubation in minutes, modified aldrete score
 
during intra op period and posto op period  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare opioid consumption .
2. To compare adverse events during emergence, such as hemodynamic changes , pain (VAS score),PONV, shivering ,agitation and convulsion.
3. To compare presence and absence of Cough.
4.To compare intra operative significant hemodynamic fluctuations in terms of blood pressure, and heart rate. 
during intra op and post op period. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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   Phase 4 
Date of First Enrollment (India)   28/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Sevoflurane,an  inhalational anesthetic agent  offer advantages such as stable intraoperative hemodynamic course and rapid emergence from anesthesia. .It has have very low blood/gas partition coefficient (0.7), which offers rapid induction and emergence from anesthesia. Hence, it was deemed  suitable for spine surgeries.

Intravenous anesthetic propofol, according to its pharmacokinetic profile, is the mainstay for total intravenous anesthesia (TIVA); it has rapid onset and offset with fewer side effects, particularly postoperative nausea and vomiting (PONV).  Propofol has long been considered a nonanalgesic intravenous hypnotic. In human volunteers, propofol at a hypnotic dose of 3.5 mcg/ml decreased pain-related regional blood flow to the thalamus and anterior cingulate cortex.   It was found to  significantly decrease pain scores by 40% and areas of hyperalgesia and allodynia in human volunteers.Propofol’s preferential binding to the HCN1 pacemaker channels further reinforces its anti-hyperalgesic effect. Moreover, the anti-inflammatory effects of propofol have been shown both in vitro[9] and in human studies[and they may be responsible for propofol role in postoperative analgesia. Propofol-based anesthesia has been shown to be associated with reduced postoperative pain compared with volatile anesthesia, whereas other studies have reported no evidence of the superiority of propofol.A recent meta-analysis comparing postoperative pain between inhalational and propofol anesthesia showed no significant differences (P value of .04) probably due to substantial heterogeneity among studies.

The aim of this prospective study is to evaluate the recovery parameters of propofol-fentanyl based TIVA compared to inhalational anesthesia in  spine surgery.

 
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