| CTRI Number |
CTRI/2024/05/067116 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study where patients undergoing surgeries of liver and gallbladder will be exposed to different gases of anesthetic agents during the operation |
|
Scientific Title of Study
|
A Randomized Controlled Trial of Recovery Profile when Switching From Isoflurane to Sevoflurane or Desflurane in Patients Undergoing Elective Non-Malignant Hepatobiliary Surgeries under General Anaesthesia |
| 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 Sagnik Datta |
| Designation |
Senior Resident |
| Affiliation |
Midnapore Medical College & hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore Town, Pin- 721101
Medinipur
WEST BENGAL
721101
India |
| Phone |
9830819502 |
| Fax |
|
| Email |
datta.sagnik1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Chattopadhyay |
| Designation |
Professor & Head |
| Affiliation |
Midnapore Medical College & hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore Town, Pin- 721101
Medinipur
WEST BENGAL
721101
India |
| Phone |
983024881 |
| Fax |
|
| Email |
sumanc24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusree Paul |
| Designation |
Junior Resident |
| Affiliation |
Midnapore Medical College & hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore Town, Pin- 721101
Medinipur
WEST BENGAL
721101
India |
| Phone |
8609653139 |
| Fax |
|
| Email |
anu.2021.exams@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of the Principal, Midnapore Medical College |
| Self Sponsored |
|
|
Primary Sponsor
|
| Name |
Office of the Principal, Midnapore medical college |
| Address |
Office of the Principal, Midnapore Medical College, Vidyasagar Road, Midnapore Town, Pin- 721101 |
| 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 |
| Dr Sagnik Datta |
Midnapore Medical College |
Rooms: Surgery OT complex, PACU and Post operative ward,
Department of Anaesthesiology, Midnapore Medical College & Hospital, Vidysagar Road, Midnapore Town, Pin- 721101
Medinipur
WEST BENGAL |
9830819502
datta.sagnik1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Midnapore Medical College |
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 |
| Comparator Agent |
Continuing isoflurane throughout the surgery |
This group of people will have oxygen (33%), nitrous oxide (67%) and 0.5 MAC isoflurane till the end of surgery
Dose: Isoflurane at 0.5% MAC throughout surgery
Frequency: Continuous administration throughout surgery
Route: Inhalational route |
| Intervention |
Switching from isoflurane to desflurane before closure is started. |
This group of people will have oxygen (33%), nitrous oxide (67%) and isoflurane 0.5MAC till closure of muscular layer is started. After that isoflurane will be turned off and desflurane will be started at 0.5MAC which will be continued till the end of surgery.
Dose: Isoflurane at 0.5% MAC followed by desflurane 0.5% MAC at time of skin closure
Frequency: Continuous administration throughout surgery
Route: Inhalational route |
| Intervention |
Switching from isoflurane to sevoflurane before closure is started. |
This group of people will have oxygen (33%), nitrous oxide (67%) and isoflurane 0.5MAC till closure of muscular layer is started. After that isoflurane will be turned off and sevoflurane will be started at 0.5MAC which will be continued till the end of surgery.
Dose: Isoflurane at 0.5% MAC followed by sevoflurane 0.5% MAC at time of skin closure
Frequency: Continuous administration throughout surgery
Route: Inhalational route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients undergoing elective non-malignant hepatobiliary surgeries
2. ASA I, II patients
|
|
| ExclusionCriteria |
| Details |
Severe ischemic heart disease, coagulopathy, chronic obstructive pulmonary disease, neuromuscular disorders
Pregnant and lactating mothers
Body mass index more than 30kg/m2
Allergy to drugs used in study or history of malignant hyperthermia in the family
Any event other than switching inhalational drugs which cause their stoppage during study
Surgery duration less than 90minutes or more than 3 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recovery profile after recovery from general anaesthesia based on CAM score (Confusion assessment score) where 0-2 means no delirium, 3-5 means mild to moderate delirium and 6-7 means severe delirium
|
Outcome will be assessed at: After surgery at extubation, 1,2,4,6,8,10,15,20,25,30,45,60,75,90 and 120 minutes post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitoring hemodynamic parameters and recovery parameters in the intraoperative and post-operative period like mean arterial pressure, heart rate, SpO2, respiratory rate, tidal volume, MAC, PEEP and ETCO2 in the intra operative period and Mean arterial pressure, heart rate, SPO2, Respiratory rate, VAS score and Ramsay sedation score, GCS and Post operative nausea and vomiting in the post operative period |
1. Intraoperative time points are: 0,3,6,9,12,15,18,21,24, 27,30,35,40,45,50,55,60,65,70,75,80,85,90,95,100,105,110,115,120,125,130,135,140,145,150,155,160,165,170,175,180 minutes
2. Post operative time points are:
1,2,4,8,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Proposed Topic of
Research: A
RANDOMIZED CONTROLLED TRIAL OF RECOVERY PROFILE WHEN SWITCHING FROM ISOFLURANE
TO SEVOFLURANE OR DESFLURANE IN PATIENTS UNDERGOING ELECTIVE NON-MALGNANT
HEPATOBILIARY SURGERIES UNDER GENERAL ANAESTHESIA
Objective of
Proposed Research:
To identify
whether switching from Isoflurane to Desflurane or Sevoflurane towards the end
of surgery can combine the advantages of Desflurane or Sevoflurane with the low
cost of isoflurane
Background of
Present Study:
The lower
solubility of sevoflurane and desflurane allows for more rapid emergence from
anaesthesia than with anaesthesia with the highly soluble but much cheaper
isoflurane. Cost control is a necessary condition particularly in low resource
setups that are highly prevalent in India. Hence in this study, we aim to
determine whether changing from isoflurane to these more soluble compounds towards
the end of surgery will provide the advantage of a cheaper overall cost along
with the advantages of rapid emergence compared to using a single agent alone.
Methodology:
This is a single
centre, prospective, randomized study on patients undergoing elective non-malignant
hepatobiliary surgeries under general anaesthesia in the surgery OT of
Midnapore Medical College & Hospital. A total of 90 patients will be
equally divided into 3 groups where 1 group will receive only one inhalational
agent, i.e., isoflurane (Group I). One group will be switched from isoflurane
to sevoflurane (Group IS) and another from isoflurane to desflurane (Group ID).
Anaesthetic and surgical management will be standardized in each group.
Switching will be done when closure of abdominal muscle layer is started. The
required parameters will be monitored in the intraoperative period and in the
post operative period till complete recovery occurs.
Expected Outcome:
It is expected
that one or both cross-over groups will have both good emergence and recovery
as well as low cost when compared to the non-crossover group. However, our null
hypothesis is that there will not be any statistically significant difference
between all the groups. The outcome will be evident after proper statistical
analysis.
|