| CTRI Number |
CTRI/2025/09/094715 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical observation with ultrasonography to study the effect in the brain circulation and their changes of positioning and insufflation of abdomen with carbon dioxide in patients scheduled for surgical procedure called laparoscopic cholecystectomy under general anaesthesia |
|
Scientific Title of Study
|
Transcranial Doppler Assessment of Cerebral Hemodynamic Changes in Adults scheduled for Elective Laparoscopic Cholecystectomy under General Anaesthesia: A Prospective Observational Study |
| 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 Mankam M Sangma |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Anaesthesia, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8787779625 |
| Fax |
|
| Email |
3mansg2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navneh Samagh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Room No 139, Department of Anaesthesiology, First Floor, OT Complex, IPD Building, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8427264480 |
| Fax |
|
| Email |
navnehsamagh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mankam M Sangma |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Anaesthesia, AIIMS Bathinda
PUNJAB
151001
India |
| Phone |
8787779625 |
| Fax |
|
| Email |
3mansg2@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bathinda, Bathinda, Punjab-151001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mankam M Sangma |
AIIMS Bathinda |
Department of Anaesthesia
Bathinda
PUNJAB |
8787779625
3mansg2@gmail.com |
|
|
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: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 - 65 years posted for elective laparoscopic cholecystectomy under general anaesthesia with supraglottic airway device.
2. American Society of Anaesthesiologists – Physical Status (ASA-PS) I & II
|
|
| ExclusionCriteria |
| Details |
1. Patients with prior head injury
2. Patients who had undergone previous cranial surgeries
3. Patients with known underlying intra-cranial pathology
4. Patients with poor temporal window
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure changes in cerebral hemodynamics during Laparoscopic Cholecystectomy with Transcranial Doppler at predetermined points using Pulsatility Index (PI). |
• Baseline (Awake)
• After securing definitive airway
• Insufflation
• Positioning
• Every 15 min thereafter, and
• Immediately within 5 minutes of extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To measure changes in other cerebral hemodynamics parameters including Mean Flow Velocity (MFV), Peak Systolic Velocity (PSV), Resistance Index (RI) and Non-invasive Intracranial Pressure (nICP) during laparoscopic cholecystectomy at predefined intervals.
• To identify the correlation of peak airway pressure and cerebral parameters during laparoscopic cholecystectomy. |
Baseline (Awake)
• After securing definitive airway
• Insufflation
• Positioning
• Every 15 min thereafter, and
• Immediately within 5 minutes of extubation |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
12/09/2025 |
| 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)
|
Other (Terminated) |
| 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
|
This study will be conducted in AIIMS Bathinda, to assess cerebral hemodynamic changes using Transcranial Doppler at various predetermined time points in adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. |