| CTRI Number |
CTRI/2025/02/080039 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of anesthetic drugs propofol and sevoflurane on the nerve of the eye in patients undergoing surgeries that use a small incisions and camera to examine and treat organs in abdomen and pelvis |
|
Scientific Title of Study
|
Comparison of effect of propofol and sevoflurane optic nerve sheath diameter in patients undergoing laproscopic procedures |
| 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 T Shalini |
| Designation |
Postgraduate ( MD Anaesthesiology) |
| Affiliation |
SRM Medical College and Research Institute |
| Address |
BBLOCK
2nd floor
Department of anesthesiology SRM Medical college and ResearchInstitute
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
621216
India |
| Phone |
9600826518 |
| Fax |
|
| Email |
shalinithiyagarajan99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Karthik |
| Designation |
Professor of Department of Anaesthesiology |
| Affiliation |
SRM Institute Of Science and Technology |
| Address |
Room no:209, B-BLOCK, 2nd floor, Department of anesthesiology,
SRM Medical college and Research Institute
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 Department of Anaesthesiology |
| Affiliation |
SRM Institute Of Science and Technology |
| Address |
Room no:209, B-BLOCK, 2nd floor, Department of anesthesiology,
SRM Medical college and Research Institute
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college and Research Institute
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
|
|
Primary Sponsor
|
| Name |
SRM MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
B BLOCK
2nd floor
Department of anesthesiology
SRM Medical college and Research Institute Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| 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 K Karthik |
SRM MEDICAL COLLEGE AND RESEARCH INSTITUTE |
B BLOCK
2nd floor
Department of anesthesiology SRM Medical college and Research Institute
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India
Tiruchirappalli
TAMIL NADU |
9600826518
shalinithiyagarajan99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMInstitutionalEthicsCommittee-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 |
sevoflurane |
here,after routine general anesthesia induction sevoflurane(MAC 1.5-2) is used for maintenance from induction and every 15mins during surgery till 24hours post operative period |
| Intervention |
propofol infusion
|
Here after routine general anesthesia induction propofol infusion through TCI pump is used for maintenance from induction and every 15mins during surgery till 24hours post operative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65
ASA PS 1-2
Both sexes.
Elective laproscopic surgeries for more than 1 hour
|
|
| ExclusionCriteria |
| Details |
Ophthalmological diseases
Pituitary adenoma
Brain Tumour
CVA
Meningitis
Patient refusal
|
|
|
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 |
Measurement of optic nerve sheath diameter using ultrasound
|
0MIN,5MINS,15MIN , 45MIN,60MIN,90MIN,120MIN,
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters like heart rate , blood pressure.
Correlation with the maximum intra abdominal pressure during surgery
|
0MIN ,5MINS , 15MIN,30MIN,45MIN,60MIN,90MIN,120MIN |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
15/02/2025 |
| 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 Yet Recruiting |
| 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 132 patients belonging to age group of18 to 65years , ASA class I and II scheduled for elective laproscopic procedures will be prospectively studied. In this double-blinded randomized control trial,
a total of 132 participants will be allocated into two groups - GROUP A – Patients will be administered after standardised GA induction with Inj. Propofol titrated in TCI @ 2.5mg/kg for Propofol infusion for maintanence ) and GROUP B- Patients will be administered after standardised GA induction with Inh. Sevoflurane titrated such that end tidal Sevoflurane is maintained at 1.0-1.5 MAC ). ONSD will be measured at various time intervals before induction, after intubation, t15min, t 30mins,t 45mins,t 60mins,t90mins,t120mins,t150mins…,post extubation ,postopervatively . Data collection will be done by observation and measurement of various parameters. |