| CTRI Number |
CTRI/2023/12/060833 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to assess time taken for recovery from anesthetic drugs when it is either purely intravenous or purely inhalational or both inhalational and intravenous in fibroadenoma surgery |
|
Scientific Title of Study
|
Comparison of Recovery Profile of Sevoflurane and Target Controlled Infusion of Propofol in Fibroadenoma Surgeries - A Randomised Controlled Trial |
| 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 Nanditha Padikkasu |
| Designation |
Postgraduate (MD Anaesthesiology) |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
B-21, B. C. Roy Ladies Hostel, SRM Nagar, SRM University, Potheri, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
09087284520 |
| Fax |
|
| Email |
nandithapadi96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Karthik |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no.: 209, B-Block, 2nd Floor, Department of Anaesthesiology, SRM Medical College and Research Institute, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Karthik |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no.: 209, B-Block, 2nd Floor, Department of Anaesthesiology, SRM Medical College and Research Institute, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
SRM |
| Address |
Room No.: 209, B-Block, 2nd Floor, Department of Anaesthesiology, SRM Medical College and Research Centre, Kattankulathur |
| Type of Sponsor |
Private 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 Nanditha Padikkasu |
SRM Institute of Science and Technology |
Room No.: 209, B-Block, 2nd Floor, Department of Anaesthesiology, SRM Medical College Hospital and Research Centre, Kattankulathur, Kancheepuram, Tamil Nadu
Kancheepuram
TAMIL NADU |
9087284520
nandithapadi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee- Students |
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 |
General Anaesthesia |
Conventional General Anaesthesia with both inhalational and intravenous agents for 1 hour |
| Intervention |
General Anaesthesia (TIVA) |
Intravenous induction and maintenance of General Anaesthesia for 1 hour |
| Intervention |
General Anaesthesia (VIMA) |
Inhalational induction and maintenance of General Anaesthesia for 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients scheduled to undergo elective excision and biopsy of fibroadenoma
2. ASA I and II patients
3. Females aged 18-45 years
4. Patients with BMI less than 24.9
5. Patients assessed to have MPC I & II
5. Anticipated surgery duration of less than 1 hour |
|
| ExclusionCriteria |
| Details |
1. Patients refusal
2. Anticipated difficult airway
3. Patients with history of GERD
4. Patients with history of achalasia
5. Patients with history of oropharyngeal abscess or mass |
|
|
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 compare the recovery profile of patients between Target Controlled Infusion group, Sevoflurane group and Conventional Anaesthesia group using Clinical Recovery Score |
1hr, 6hr, 12hr, 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor duration of hospital stay using PADSS Score |
24hr |
|
|
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)
|
01/01/2024 |
| 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="6"
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
|
A total of 90 patients belonging to the age group of 18-45 years, assessed under ASA I and ASA II, scheduled for fibroadenoma excision surgeries will be prospectively studied. In this double-blinded randomised controlled trial, a total of 90 participants will be allocated into three groups- Group A(TIVA), Group B(VIMA) and Group C(Conventional General Anaesthesia). All three groups will receive premedication with Inj. Glycopyrrolate 0.2mg IV, Inj. Ondansetron 4mg IV, Inj. Midazolam 0.04mg/kg IV. All patients will receive Inj. Fentanyl 2mcg/kg as analgesic and 100% O2 via face mask prior to LMA insertion. Patients will be induced according to the group that they have been allocated into. Standardised Proseal LMA is inserted with their size depending on the weight of the patients. All patients will be assessed for their recovery profile using Clinical Recovery Score postoperatively. After 24 hours, in the post operative period, PADSS Score will be assessed. Data collection will be done by observation and measurement of various parameters. |