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CTRI Number  CTRI/2021/10/037038 [Registered on: 01/10/2021] Trial Registered Prospectively
Last Modified On: 30/09/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   To check whether low flows of Anaesthesia gases can be used during gynaecological surgery  
Scientific Title of Study   Feasibility and Efficacy of minimal flow anaesthesia in gynaecological laparoscopic surgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rakhee Goyal 
Designation  Lead Consultant 
Affiliation  Madhukar Rainbow Childrens Hospital 
Address  1st Floor, Department of Anaesthesia Madhukar Rainbow Childrens Hospital FC 29/5 Gitanjali Malviya Nagar New Delhi

South
DELHI
110017
India 
Phone  7798225637  
Fax    
Email  rakheegoyalkumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rakhee Goyal 
Designation  Lead Consultant 
Affiliation  Madhukar Rainbow Childrens Hospital 
Address  1st Floor, Department of Anaesthesia Madhukar Rainbow Childrens Hospital FC 29/5 Gitanjali Malviya Nagar New Delhi

South
DELHI
110017
India 
Phone  7798225637  
Fax    
Email  rakheegoyalkumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rakhee Goyal 
Designation  Lead Consultant 
Affiliation  Madhukar Rainbow Childrens Hospital 
Address  1st Floor, Department of Anaesthesia Madhukar Rainbow Childrens Hospital FC 29/5 Gitanjali Malviya Nagar New Delhi

South
DELHI
110017
India 
Phone  7798225637  
Fax    
Email  rakheegoyalkumar@gmail.com  
 
Source of Monetary or Material Support  
Madhukar Rainbow Childrens Hospital 
 
Primary Sponsor  
Name  Madhukar Rainbow Childrens Hospital 
Address  FC 29/5 Gitanjali Malviya Nagar New Delhi 
Type of Sponsor  Private hospital/clinic 
 
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 Rakhee Goyal  Madhukar Rainbow Childrens Hospital  1st Floor, Department of Anaesthesia FC 29/5, Gitanjali Malviya Nagar New Delhi 110017
South
DELHI 
7798225637

rakheegoyalkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Madhukar Rainbow Childrens Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  ASA I & II patients undergoing gynaecological laparoscopic surgery 
 
ExclusionCriteria 
Details  Emergency surgery
Anaesthesia duration <1 hour
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the feasibility of ventilation during anaesthesia with gas flows upto 0.5 L/min  At 1hr, 2hr, 3hr, 4hr, 5hr and SOS during surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess any adverse effects with flows upto 0.5 L/min   At 1hr, 2hr, 3hr, 4hr, 5hr and SOS during surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/10/2021 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Low-flow anesthesia (fresh gas flows less than 1 L/min) has several advantages, including preservation of heat and humidity of inspired gases, providing cost benefit and reduction of atmospheric pollution. The reduction of fresh gas flows (FGF) to 500 ml/min (known as minimal-flow anesthesia) would provide even more advantages of low-flow anaesthesia, but its conduct requires constant monitoring and vigilance. Several studies have established the safety as well as efficacy of low flow anaesthesia, however not much literature is available on the use of minimal flow anaesthesia during laparoscopic surgery. Ventilation during laparoscopic surgery poses challenges of its own, especially with more patients with higher BMI coming in for surgery. Therefore this observational study has been planned, so as to see if the benefits of minimal flow anaesthesia can be extended to laparoscopic surgery on a wider basis. This study aims to establish the feasibility of minimal gas flow anesthesia in adult females undergoing elective gynaecological laparoscopic surgery, who fall in ASA I and II classification, over a period of one year from the start of patient enrolment.

 
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