| CTRI Number |
CTRI/2022/10/046418 [Registered on: 12/10/2022] Trial Registered Prospectively |
| Last Modified On: |
11/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the onset and recovery time of minimal flow sevoflurane and desflurane anaesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of onset and recovery characteristics of minimal flow Sevoflurane and Desflurane anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MEGHA RANJAN |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Anaesthesiology and Intensive care, B.L Taneja block, Maulana Azad medical college,Bahadur shah Zafar Marg ,Central Delhi,110002,INDIA
Central
DELHI
110002
India |
| Phone |
9315937836 |
| Fax |
|
| Email |
meghakmr5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUNISHA AGARWAL |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical college |
| Address |
Department of Anaesthesiology and Intensive care,B. L Taneja block, Maulana Azad medical college,Bahadur shah Zafar Marg,central Delhi 110002, INDIA
Central
DELHI
110002
India |
| Phone |
9968604216 |
| Fax |
|
| Email |
munisha.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MEGHA RANJAN |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaethesiology and Intensive care, B L Taneja block,Maulana Azad Medical College, Bahadur Shah Zafar Marg, Central Delhi 110002
Central
DELHI
110002
India |
| Phone |
9315937836 |
| Fax |
|
| Email |
meghakmr5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur shah Zafar Marg Central Delhi 110002 India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Megha Ranjan |
Maulana Azad Medical College and associated hospitals |
OT block Department of Anaesthesiology MAMC and lok nayak hospital bahadur shah zafar mard Central Delhi 110002 India
Central
DELHI |
9315937836
meghakmr5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,MAMC |
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 |
Desflurane |
Minimal flow anaesthesia at 0.5l/min using desflurane after acheiveing MAC of 0.9 |
| Comparator Agent |
Sevoflurane |
Minimal flow anaesthesia using sevoflurane at flow rate of 0.5L/min after acheiveing MAC of 0.9 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65 years
2. ASA physical status 1 and 2
3. Duration of surgery >1 hour |
|
| ExclusionCriteria |
| Details |
1. History of hepatic,renal,or cardiovascular disease
2.Patient with chronic obstructive pulmonary disease
3. Pregnant patient
4.Obesity (BMI >30kg/m2) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Onset time
2.Recovery time |
1.time in seconds after intubation to acheive MAC of 0.9
2.time in seconds after vaporizer closure to eye opening |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.systolic blood pressure, diastolic blood pressure, heart rate and Spo2
2.Bispectral index
3.end tidal carbon dioxide concentration
4.Anaesthetic agent consumption
5.carbon dioxide equivalents
|
1.Baseline reading and after 5,10,15,30 minutes of induction and after 30 minutes thereafter |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
15/10/2022 |
| 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
|
Sevoflurane and Desflurane are the two most common gases used in minimal flow anaesthesia. The aim of this study is to evaluate and compare the onset and recovery characteristics in minimal flow sevoflurane and desflurane anaesthesia. Patients will be divided into two groups Group D and Group S receiving Desflurane and sevoflurane respectively by computer generated sequence. Standard anaesthesia induction protocol will be followed,and airway will be secured using endotracheal tube or supraglottic device, following which inhalation agent will be started according to the allotted group. Primary objective is to see time to achieve MAC of 0.9 and eye opening following vaporizer closure whereas secondary objective is to see the hemodyamic effects, BIS value along with carbon footprints of minimal flow sevoflurane and Desflurane anaesthesia. |