| CTRI Number |
CTRI/2024/06/068816 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Inhalational Anaesthesia and Total Intravenous Anaesthesia on incidence of Postoperative Ageusia |
|
Scientific Title of Study
|
Comparison of Inhalational Anaesthesia and Total Intravenous Anaesthesia on Occurence of Postoperative Ageusia - Prospective Randomized 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 |
Vignesh A |
| Designation |
Post-graduate student |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute,
Pillayarkuppam, Kirumampakkam, Puducherry - 607 402
Pillayarkuppam, Kirumampakkam, Puducherry - 607 402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8220107529 |
| Fax |
|
| Email |
vigneshvicky7445@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Antony John Charles S |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Mahatma Gandhi medical College, Puducherry.
Pillayarkuppam, Kirumampakkam, Puducherry - 607 402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9600931100 |
| Fax |
|
| Email |
anjocharlie@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Antony John Charles S |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Mahatma Gandhi medical College, Puducherry.
Pillayarkuppam, Kirumampakkam, Puducherry - 607 402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9600931100 |
| Fax |
|
| Email |
anjocharlie@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute, Puducherry - 607 402 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical college and Research Institute |
| Address |
Pillarkuppam, Kirumanpakkam, Puducherry - 607 402 |
| 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 |
| Vignesh |
Department of Anesthesiology |
A-2, Hospital Block, Mahatma Gandhi Medical College and Research Institute
Pondicherry
PONDICHERRY |
8220107542
vigneshvicky7445@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College & Research Institute, Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inhalational agent |
Patient will be induced with Injection Thiopentone (6mg/kg) and Injection Atracurium (0.5mg/kg) after 3 minutes, appropriate size Endotracheal tube will be secured and fixed after confirming by the appearance of Capnography (ETCO2) and also by 5 point auscultation, patient will be maintained with 3 liters of oxygen, 3 liters of Air and Sevoflurane 1.5% , After 15 minutes low flow anesthesia will be initiated, Inj. Atracurium (0.05mg/kg) as when needed, last dose will be 30mins before dressing. The Inhalational agent Sevoflurane will be discontinued prior to skin closure and after dressing Patient will be extubated by administration of reversal agent Inj. Neostigmine 60mcg/kg and Inj. Glycopyrolate 1/5 dose of Neostigmine. |
| Intervention |
Total Intravenous Anesthesia (TIVA) |
Patients will be induced with Inj. Propofol (2mg/kg) Inj. Atracurium (0.5mg/kg) after 3 minutes appropriate size Endotracheal tube will be secured and fixed after confirming by the appearance of Capnography (ETCO2) and also by 5 point auscultation, patient will be maintained with 3 liters of Oxygen, 3 liters of air and Inj. Propofol infusion. The infusion will be administered using B|BRAUN Perfusor® compact with 20ML syringe along with 100cm Pressure Monitoring Line connecting to a 3 way connector to the patients IV line infusion will be set at the rate of 6ml / hour, after 15minutes low flow anesthesia will be initiated, Injection Atracurium (0.05mg/kg) as and when needed, last dose will be 30mins before dressing . Inj. Propofol infusion will be discontinued prior to the skin closure. After dressing, patient will be extubated by administration of Reversal agent Inj. Neostigmine 60mcg/kg and Inj. Glycopyrolate 1/5 dose of Neostigmine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient should be in the age of 18-60 years
Patient to get fit under ASA 1 and ASA 2
Patient should undergo elective surgery under volatile agents and Total Intravenous Anesthesia (TIVA).
Duration of Surgery not exceeding more than 1.30 hours.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Taste sensation of patients undergoing surgery under inhalational anesthetic agents and TIVA |
Pre-operatively and 1,3, 5, 7 and 9 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the recovery of taste between two groups. |
Pre-operatively and 1,3, 5, 7 and 9 hours post-operatively |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/06/2024 |
| 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="0"
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
|
The study aims to compare the
effect of volatile anesthetic agents and Total Intravenous Anesthesia (TIVA) on
post-operative loss of taste in Indian patient population using lab preparation
solutions in different concentration for sweet, sour, bitter and salt among 52 patients who are fulfilling the selection criteria and giving consent for participating in the study. |