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CTRI Number  CTRI/2024/06/068595 [Registered on: 07/06/2024] Trial Registered Prospectively
Last Modified On: 06/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Conventional versus ventilator assisted priming of Anesthesia breathing circuit using sevoflurane 
Scientific Title of Study   Conventional priming versus ventilator assisted priming of Anesthesia circuit with sevoflurane for induction of Anesthesia- prospective factorial experimental 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  Damini S 
Designation  PG student 
Affiliation  Kidwai memorial institute of oncology  
Address  Kidwai memorial institute of oncology, Department of Anesthesia, OT division, Room no 105, DR MH, Marigowda road, Hombegowda Nagar, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  7022303766  
Fax    
Email  daminishekar77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Namrata Ranganath  
Designation  Professor 
Affiliation  Kidwai memorial institute of oncology  
Address  Kidwai memorial institute of oncology, Department of Anesthesia, Ot division, Room no 105, DR MH, Marigowda road, Hombegowda Nagar, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9880642830  
Fax    
Email  namrang@gmail.com  
 
Details of Contact Person
Public Query  
Name  Damini S 
Designation  PG student 
Affiliation  Kidwai memorial institute of oncology  
Address  Kidwai memorial institute of oncology, Department of Anesthesia, OT division, Room no 105,DR MH, Marigowda road, Hombegowda Nagar, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  7022303766  
Fax    
Email  daminishekar77@gmail.com  
 
Source of Monetary or Material Support  
Kidwai Memorial institute of oncolgy, Department of Anesthesia, OT division, Room no 105, DR MH, Marigowda road, Hombegowda Nagar, Bengaluru, India , 560029 
 
Primary Sponsor  
Name  Damini S 
Address  Kidwai memorial institute of oncology, Department of Anesthesia, OT division, Room no 105, DR MH, Marigowda road, Hombegowda Nagar, Bengaluru 560029 
Type of Sponsor  Other [SELF] 
 
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 Damini S  Kidwai Memorial Institute Of Oncology   Department Of Anesthesia, OT division, Room no 105, Dr MH, Marigowda road, Hombegowda Nagar, Bengaluru 560029
Bangalore
KARNATAKA 		 7022303766

daminishekar77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kidwai Memorial institute of oncology   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  Conventional versus ventilator assisted priming of breathing circuit using SEVOFLURANE Comparator arm is conventional priming of breathing circuit using sevoflurane Interventional arm is ventilator assisted priming of breathing circuit with sevoflurane   Sevoflurane 8 percent inhalational agent is used for priming the breathing circuit and time taken to reach 6 percent sevoflurane concentration at the patient end of the circuit is noted in conventional and ventilator assisted methods. Patient is induced with 8% sevoflurane by nasal route and end point of induction of Anesthesia is noted by loss of eye lash reflex.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient consenting for study
Patient belonging to ASA garde 1 and 2 
 
ExclusionCriteria 
Details  Patient’s refusal
Patient belonging to ASA 3 and 4
Patient with any known allergy to drugs
Patient with any feature of difficult airway 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the time taken to prime the Anesthesia breathing circuit using sevoflurane  Time taken for priming has to be measured. Time taken for priming of Anesthesia breathing circuit is not prefixed.
Time take to reach 6 percent sevoflurane concentration at the patient end of the breathing circuit is noted in both conventional and ventilator assisted priming techniques.  
 
Secondary Outcome  
Outcome  TimePoints 
1. To measure the time taken for inhalational induction of Anesthesia breathing circuit primed with sevoflurane
2. Cost analysis of sevoflurane consumption in priming Anesthesia circuit & inhalational induction of Anesthesia  		 Time taken for induction of Anesthesia has to be measured. Time taken for induction of Anesthesia is not prefixed. End point of induction is noted by observing the loss of eye lash reflex 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   01/07/2024 
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 Yet Recruiting 
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  
Anaesthesia breathing systems serve as a conduit to deliver anesthetic and other gases to a patient. When rapid induction is intended, inhalational induction is a feasible alternative to intravenous induction. The purpose of inhalational induction is to achieve an adequate depth of anesthesia, minimise induction time and ensure maintenance of spontaneous breathing while minimizing operating room pollution due to inhalational anaesthetic agents. The speed of inhalational induction depends on a variety of factors, of which priming the breathing circuit with volatile anaesthetics play a vital role. Sevoflurane a sweet smelling, nonflammable, highly fluorinated methyl isopropyl ether is used as an inhalational anaesthetic for induction and maintenance of general anesthesia. The safety and efficacy of sevoflurane are well established. It is a potent vasodilator, bronchodilator and has minimal impact on airway and hemodynamic stability.

A recommended inhaled sevoflurane concentration for vital capacity induction is 6%. Priming the circuit for an application of inhalational agent depends on the fresh gas flow (FGF), type of circuit and the priming technique used. Based on the previous studies, the priming time for desirable concentration of sevoflurane varied between 30 seconds to 5 minutes. Majority of priming techniques used in literature have used a passive method of priming, that is, allowing the breathing circuit to fill unaided with FGF containing either oxygen alone or an oxygen and nitrous oxide or oxygen and air combination along with volatile anaesthetics. Mechanical ventilation with the ventilator set in volume controlled mode provides a rapid and effective method of priming the breathing circuit with desired anaesthetic concentration.

This study compares ventilator assisted priming (VAP) and a passive priming technique using different fresh gas flows. This study measures the time taken to prime the anesthesia breathing circuit in VAP and passive priming technique and time taken for inhalational induction using primed circuit. Cost analysis of sevoflurane consumption is also noted.
 
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