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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  
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 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  
Status 
Not Applicable 
 
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)

 

 
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