| 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
|
|
|
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
|
|
|
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. |