| CTRI Number |
CTRI/2022/02/040259 [Registered on: 14/02/2022] Trial Registered Prospectively |
| Last Modified On: |
08/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of inhalational agent wash in wash out between two age population based on duration of exposure |
|
Scientific Title of Study
|
A parallel group randomised trial for determination of sevoflurane wash in and wash out characteristics based on the duration of inhalational agent exposure between 2 age groups. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHWAETHA R |
| Designation |
Junior resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,
6th floor,
Sri Ramachandra Institute of Higher Education and Research,
1, Mount Poonamallee road,
Ramachandra Nagar, Porur,
Chennai.
Department of Anaesthesiology,
6th floor,
Sri Ramachandra Institute of Higher Education and Research,
1, Mount Poonamallee road,
Ramachandra Nagar, Porur,
Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
8056187400 |
| Fax |
|
| Email |
shwaetha@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sree Kumar E J |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,
6th floor,
Sri Ramachandra Institute of Higher Education and Research,
1, Mount Poonamallee road,
Ramachandra Nagar, Porur,
Chennai
Department of Anaesthesiology,
6th floor,
Sri Ramachandra Institute of Higher Education and Research,
1, Mount Poonamallee road,
Ramachandra Nagar, Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sree Kumar E J |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,
6th floor,
Sri Ramachandra Institute of Higher Education and Research,
1, Mount Poonamallee road,
Ramachandra Nagar, Porur,
Chennai
Department of Anaesthesiology,
6th floor,
Sri Ramachandra Institute of Higher Education and Research,
1, Mount Poonamallee road,
Ramachandra Nagar, Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self, Department of Anaesthesiology, 6th floor,
Sri Ramachandra Insititute of Higher education ,
1, Mount Poonamallee road,
Ramachandra nagar, Porur,
Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Shwaetha R |
| Address |
Sri Ramachandra Institute of Higher education and research,
1, Mount Poonamallee road,
Ramachandra nagar, Porur,
Chennai |
| Type of Sponsor |
Other [Self] |
|
|
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 Shwaetha R |
Sri Ramachandra Institute of Higher Education and Research |
Department of Anaesthesiology,
6th floor,
1, Mount Poonamallee road , Ramachandra Nagar, Porur
Chennai
TAMIL NADU |
8056187400
shwaetha@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Wash in and wash out characteristics of sevoflurane in geriatric and young adult population. |
Wash in and wash out characteristics will be assessed between geriatric and young adult population based on the duration of exposure 15 minutes. |
| Intervention |
Wash in and wash out characteristics of sevoflurane in geriatrics and young adult population |
Wash in and wash out characteristics will be assessed between geriatric and young adult population based on the duration of exposure 45 and 90 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgery under general anaesthesia
ASA 1,2,3
Exposure: Age 65 and above
Control: age 20 - 40 years |
|
| ExclusionCriteria |
| Details |
Patient’s refusal to give consent
Change of plan intraoperatively
Use of intravenous anaesthetic agent other than propofol for induction
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the wash in and wash out characteristics of sevoflurane in elderly and young adult population for 15 ,45, 90 minutes of exposure |
elderly and young adult population for 15 ,45, 90 minutes of exposure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare wash in and wash out characteristics based on body composition based on bio impedance analysis |
Preoperative |
|
|
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)
|
09/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/03/2022 |
| 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
|
Parallel group randomised trial for determination of sevoflurane wash in and wash out characteristics in geriatric age group and young adult population based on duration of exposure 15, 45 and 90 minutes. Previous literature in geriatric age group is less, hence we decided to conduct this study. We hypothesise that wash in and wash out in geriatric age group will be delayed compared to young adult population. |