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CTRI Number  CTRI/2024/02/063076 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of gaseous anaesthesia agents on the delivery of oxygen and the oxygen content at various interval and on the heart rate, blood pressure and oxygen content of the blood during the process of oxygenating a patient before putting a tube for assisting breathing during surgery. 
Scientific Title of Study   Effect of inhalational agents on pre-intubation oxygenation and hemodynamic parameters:A randomized, single blind, pilot 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  Dr Sandra Merin Thomas 
Designation  Post-Graduate Junior Resident 
Affiliation  AIIMS, Raipur 
Address  Department of Anaesthesiology, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8921077911  
Fax    
Email  sannu4796@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandkishore Agrawal 
Designation  Professor and head of the department 
Affiliation  AIIMS, Raipur 
Address  Department of Anaesthesiology, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9373103294  
Fax    
Email  nkagrawal1963@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nandkishore Agrawal 
Designation  Professor and head of the department 
Affiliation  AIIMS, Raipur 
Address  Department of Anaesthesiology, AIIMS Raipur


CHHATTISGARH
492099
India 
Phone  9373103294  
Fax    
Email  nkagrawal1963@gmail.com  
 
Source of Monetary or Material Support  
AIIMS,Raipur 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Sandra Merin Thomas  All India Institute Of Medical Sciences, Raipur  All India Institute Of Medical Sciences, A Block OT 4th Floor, Great Eastern Rd, opposite Gurudwara,AIIMS Campus, Tatibandh, Raipur,Chhattisgarh
Raipur
CHHATTISGARH 
08921077911

sannu4796@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Raipur  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 
Intervention  Use of inhalational agents during pre-intubation oxygenation.  Group A: Patients who will receive inhalational anaesthetic isoflurane set at a dial concentration of 1% during pre-intubation oxygenation with fresh gas flow set at 8l/min through anaesthetic facemask for 5 minutes. Group B: Patients who will receive inhalational anaesthetic sevoflurane set at a dial concentration of 1% during pre-intubation oxygenation with fresh gas flow set at 8l/min through anaesthetic face mask for 5 minutes.  
Comparator Agent  Use of only 100% oxygen during pre-intubation oxygenation with the fresh gas flow set at 8l/min  Group C: Patients who will not be receiving any inhalational anaesthetic agents during pre-intubation oxygenation with a fresh gas flow set at 8l/min through anaesthetic face mask for 5 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age: adults aged between 18 – 60 years
2.Gender: Male and female
3.Volatile anaesthesia with the use of Muscle relaxants
4.Elective Surgery
5.ASA-PS I-III
6. BMI 18.5-29.9 Kg/m2 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Pregnant women
3.Improper fit of oronasal mask, anticipated and unanticipated difficult mask ventilation
4.Undergoing Rapid Sequence Intubation
5.Patients with significant cardio-respiratory disease like Coronary artery disease,
Stroke, Peripheral vascular disease, Aortic disease, Deep vein thrombosis, Heart
failure, COPD, Pneumonia, Asthma, Cystic fibrosis etc 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
the addition of inhalational anaesthetic will affect pre intubation oxygenation negatively, but hemodynamic parameters like heart rate,blood pressure, oxygen saturation will not be affected much.  5 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   03/03/2024 
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  
Pre-intubation oxygenation is a recommended procedure general anaesthesia where 100% oxygen is delivered with a goal to increase the safe apneoa time( the delay until oxygen saturation falls to 90%). Achieving this target is dependent on the efficacy of pre oxygenation which can further vary based on the fio2, duration of pre oxygenation and alveolar ventilation. as fio2 is the fraction of o2 among the total gas, any other gas administered with 100% fio2 in the alveolar content will likely impact pre oxygenation. the study aims to quantify this.
also addition of inhalational agents during pre intubation oxygenation and ventilation in everyday practice helps in maintaining the depth of anaesthesia. further, undesirable hemodynamic effects associated with pre oxygenation like a decrease in heart rate and increase in blood pressure and systemic vascular resistance with hyperoxia which are countered by use of inhalational agents. the weightage of such advantages against possible impact on oxygenation target has to be evaluated.
All eligible patients will be told about the study. base line vitals like hr,bp,rr,spo2 are noted down. patients are induced with fentanyl 2 mcg/kg and propofol 2 mg/kg and pre intubation oxygenation is done with fresh gas flow fixed at 8l/min.group A will recieve 1% sevoflurane, group B will recieve 1% isoflurane and group C will get no inhalational agents. Parameters like fio2,feo2,spo2, etco2,hr,bp, minute ventilation, airway pressures and time to reach feo2 of 85% and 90% are noted down and compared. we expect that the addition of inhalational anaesthetic will affect pre intubation oxygenation negatively, but the hemodynamics will not be affected much.
 
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