| CTRI Number |
CTRI/2025/07/091708 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NON-INVASIVE INTRA CRANIAL PRESSURE assessment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Change in brain pressure during gallbladder resection- A study |
|
Scientific Title of Study
|
Comparison of non-invasive intracranial assessment during laproscopic cholecystectomy using the Budohoski equation versus
Xing Wang equation
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Sharma |
| Designation |
Resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Surgery, Indira Gandhi Medical College
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018388348 |
| Fax |
|
| Email |
neurocrticalcareneuroanesthes@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kunal Kumar Sharma |
| Designation |
Assistant Professor |
| Affiliation |
INDIRA GANDHI MEDICAL COLLEGE |
| Address |
Neuroanesthesia cell, Department of Anesthesia
Indira Gandhi Medical College
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9945602747 |
| Fax |
|
| Email |
kunaal_kumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunil Sharma |
| Designation |
Resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Surgery, Indira Gandhi Medical College
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018388348 |
| Fax |
|
| Email |
neurocrticalcareneuroanesthes@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Indira Gandhi Medical College,
Ridge-Sanjauli Road,
Shimla
Himachal Pradesh, India |
| 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 Sunil Sharma |
Indira Gandhi Medical College |
Operation theater 1 and 2, B- Block, Second floor, Department of Anesthesia, Indira Gandhi Medical College,
Ridge-Sanjauli road, Shimla
Shimla
HIMACHAL PRADESH |
7018388348
neurocrticalcareneuroanesthes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Medical College, Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K811||Chronic cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Budhoski equation |
Intracranial pressure assessment in one study group will be done using Budhoski equation for which the data obtained from intraoperative transcranial color coded duplex sonography will be used at the specified time points in protocol |
| Comparator Agent |
Xing Wang equation |
Intracranial pressure assessment in other study group will be done using Xing & Wang equation for which the data obtained from intraoperative optic nerve sheath diameter assessment will be used at the specified time points in protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
Body mass index less than 30
|
|
| ExclusionCriteria |
| Details |
Known intracranial pathology or raised ICP
Ophthalmic disease affecting optic nerve
Carotid artery stenosis or vascular malformations
Poor acoustic windows for TCCD
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of mean estimated ICP between the two groups at each time point |
Timepoint 1- After securing the airway, but prior to pneumoperitoneum
Timepoint 2- At 15 minutes after insufflation
Timepoint 3- 2 minutes after release of pneumoperitoneum
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between TCCD-derived ICP and ONSD at each time point
|
Timepoint 1- After securing the airway, but prior to pneumoperitoneum
Timepoint 2- At 15 minutes after insufflation
Timepoint 3- 2 minutes after release of pneumoperitoneum
|
| Time of emergence from anesthesia |
After discontinuation of volatile agent uptil eye opening to verbal command |
| Incidence of delayed emergence between the two groups |
Will start from 15 minutes after stopping the anesthetics and administering the reversal agent from muscle relaxation |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
05/08/2025 |
| 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="0"
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
|
Primary objective
To compare intracranial pressure derived from Budohoski equation to that derived from Xing & Wang equation in patients undergoing laproscopic cholecystectomy
Secondary Objectives:
(i)
To observe and compare the effect of
different intra-peritoneal insufflation pressures on cerebral blood flow
velocity and ICP
(ii)
To observe and compare the effect
of different intra-peritoneal insufflation pressures on ONSD and ICP
(iii)
To observe and compare the effect
of ICP elevation during pneumoperitoneum with post-operative emergence from
anesthesia
|