| 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
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 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
|
|
|
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.
|