| CTRI Number |
CTRI/2024/03/063503 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing how Sevoflurane differs from Isoflurane on affecting post operative cognitive dysfunction after a laparoscopic cholecystectomy surgery done under general anesthesia. |
|
Scientific Title of Study
|
Comparison of Sevoflurane and Isoflurane on post operative cognitive dysfunction following laparoscopic cholecystectomy. |
| 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 Supratik Ganguly |
| Designation |
Junior resident |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Rajendra Institute of Medical Sciences , Department of Anesthesiology .
Ranchi
JHARKHAND
834009
India |
| Phone |
7003244409 |
| Fax |
|
| Email |
itisthegunners@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Assistant Professor, |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Rajendra Institute of Medical Science, Department of Anesthesiology ,Bariatu , Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
7004993204 |
| Fax |
|
| Email |
mukeshgmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Barun Ram |
| Designation |
Assistant Professor, Critical Care Medicine |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Rajendra Institute of Medical Science campus, New Trauma centre , Critical Care Unit,Bariatu , Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
7903679896 |
| Fax |
|
| Email |
barunrims2004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences, Bariatu, Ranchi,PIN-834009,Jharkhand. |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Bariatu , Ranchi , Jharkhand 834009 |
| 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 Barun Ram |
Rajendra Institute of Medical Sciences |
Department of Anesthesiology RIMS ,Bariatu , Ranchi , Jharkhand 834009
Ranchi
JHARKHAND |
07903679896
barunrims2004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Rajendra Institute of Medical Sciences, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Isoflurane |
After induction patients will be maintained with inhaled Isoflurane in the 1-1.5 MAC range for the duration of surgery. |
| Intervention |
Sevoflurane |
After induction patient will be maintained with inhaled Sevoflurane in 1-1.5 MAC range for the duration of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Those willing to give written - informed consent.
2.ASA physical status I and II patients. |
|
| ExclusionCriteria |
| Details |
1. Refusal of the patient.
2. Age less than 18 years and more than 60 years.
3. Patients above ASA III grade.
4.Patients who do not speak hindi or english.
5. Patients who do not have an elementary school education. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out how Sevoflurane differs from Isoflurane on affecting postoperative cognitive dysfunction following a laparoscopic cholecystectomy surgery. |
until 24 hours post-extubation after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the incidence and severity of post operative shivering between sevoflurane and isoflurane.
2.To find out the incidence of post operative nausea and vomiting between sevoflurane and isoflurane. |
until 24 hours post-extubation after the procedure. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
14/03/2024 |
| 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 Applicable |
| 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
|
Laparoscopic cholecystectomy has been traditionally performed under general anesthesia. Sevoflurane is a halogenated inhalational agent containing fluorine.It is an excellent choice for smooth and rapid inhalational induction in pediatric and adult patients.The minimum alveolar concentration of Sevoflurane is 2.0%. Isoflurane is a non-flammable volatile anaesthetic with a pungent etheral odor.The minimum alveolar concentration of Isoflurane is 1.2%. Postoperative cognitive dysfunction is defined as a new cognitive impairment arising after a surgical or anaesthetic procedure.Its diagnosis requires both pre and postoperative psychometric testing. The Montreal Cognitive Assessment was designed as a rapid screening instrument for mild cognitive dysfunction.It assesses different cognitive domains attention and concentration , executive functions , memory, language visuoconstructional skills , conceptual thinking, calculations and orientation. The total possible score is 30 points. A score of 26 or above is considered normal.The Montreal Cognitive Assessment has a sensitivity of more than 90 percent for detecting even mild cognitive dysfunction. In our study we aim to compare the effect of Sevoflurane and Isoflurane on post-operative cognitive dysfunction following laparoscopic cholecystectomy. |