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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
Intervention / Comparator Agent
|
|
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. |