| CTRI Number |
CTRI/2024/06/069009 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of smell after effect of inhalational agents and total intravenous anaesthesia |
|
Scientific Title of Study
|
Comparison of anosmic effect of inhalational agents and total intravenous anaesthesia - a 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 |
M Aarthi |
| Designation |
Post Graduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
MahatmaGandhi Medical College and Research Institute
Department of Anaesthesiology,room no:1,
MGMCRI
Pondicherry PONDICHERRY -607402 India |
| Phone |
9488889299 |
| Fax |
|
| Email |
aarthim.20oct@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Antony John Charles |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
MahatmaGandhi Medical College and Research Institute
Department of Anaesthesiology,MGMCRI
Pondicherry PONDICHERRY 607402 India |
| Phone |
9600931102 |
| Fax |
|
| Email |
antonyjcs@mgmcri.ac.in |
|
Details of Contact Person Public Query
|
| Name |
M Aarthi |
| Designation |
Post Graduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
MahatmaGandhi Medical College and Research Institute,
Department of Anaesthesiology,room no:1,
MGMCRI
Pondicherry PONDICHERRY -607402 India |
| Phone |
9488889299 |
| Fax |
|
| Email |
aarthim.20oct@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute,Pilliarkuppam,Pondicherry-607402,INDIA |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute Pondicherry |
| Address |
MahatmaGandhi Medical College and Research Institute,Pilliarkuppam,Pondicherry-607402,INDIA |
| Type of Sponsor |
Private 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 M Aarthi |
Mahatma Gandhi Medical College and Research Institute |
Department of Anaesthesiology,Mahatma Gandhi Medical College and Research Institute,pondicherry -cuddalore ECR road, pillaiyarkuppam, Pondicherry Pondicherry PONDICHERRY |
9488889299
aarthim.20oct@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 COMMITTE |
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 |
PROPOFOL |
IV-2mg per kg
duration 1-1.5hrs |
| Comparator Agent |
Sevoflurane |
inhalational agent
1-2%
duration 1-1.5hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient should be in the age of 18-60 years
2. Patient to go fit under ASA1 and ASA2
3. Patient should undergo elective surgery under inhalation agent and total intravenous anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient with history of anosmia
Patient who are potential for difficult airway management
Patient with the history of URI and LRI
Patient allergic to egg
Patient who has refused to give consent
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sense of smell of patients undergoing surgery under general anaesthesia and total intravenous anaesthesia |
1st, 3rd, 5th, 7th and 9th hours of postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for recovery of smell sensation |
1st, 3rd, 5th, 7th and 9th hours of postoperatively |
|
|
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)
|
26/06/2024 |
| 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
|
COMPARISON OF ANOSMIC EFFECT OF INHALATIONAL AGENTS AND TOTAL INTRAVENOUS ANAESTHESIA -A PROSPECTIVE COMPARATIVE STUDY
Study population: All patients who will be undergoing elective surgery under general anaesthesia(GROUP-G)and Total Intravenous Anaesthesia (TIVA)(GROUP-T). Study setting: Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute. Study period: After obtaining ethical clearance from the IHEC. Inclusion and exclusion criteria: Inclusion criteria: 1. Patient should be in the age of 18-60years 2. Patient to get fit under ASA 1andASA2 3. Patient should undergo elective surgery under general anaesthesia and Total Intravenous Anaesthesia (TIVA). Exclusion criteria: 1. Patient with history of anosmia. 2. Patients who are potential for difficult airway management. 3. Patient with history of preoperative URI or LRI within 14 days of recovery. 4. Patients with severe hepatic or renal failure , allergy to medications of the study, BMI>30. 5. Pregnant female 6. Patient allergic to egg. 7. Patient who refused to give consent. After satisfying the inclusive and exclusive criteria , written informed consent will be taken from the study participants. After informed consent the participants would made comfortable and made self test the odorants. Check both nostrils of the patient. Patient will be asked to close both their eyes and one nostril and now the patient will be asked to sniff one of the Indian spices like clove oil & asafetida and identify. After one min patient will be asked to sniff coffee been seed in order to neutralize the previous odor of Indian spice and after another one min patient Will be asked to sniff another Indian spice. Repeat the procedure on other nostril. This will be done preoperatively and postoperatively after elective surgeries under general anaesthesia(GROUP-G)and total intravenous anaesthesia(GROUP-T) |