| CTRI Number |
CTRI/2024/06/068979 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using ultrasound to measure the width of nerve supplying the eye in adults posted for laparoscopic surgeries under general anesthesia |
|
Scientific Title of Study
|
Serial Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Adults Scheduled for Elective Abdominopelvic Laparoscopic Surgery under General Anaesthesia: A Prospective Observational Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| omtri |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Omna Trivedi |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesiology
1st floor A-Block
AIIMS Bathinda
Mandi Dabwali Road
151001
Department of Anaesthesiology
1st floor A-Block
AIIMS Bathinda
Mandi Dabwali Road
151001
Bathinda
PUNJAB
151001
India |
| Phone |
8830172361 |
| Fax |
|
| Email |
omnatrivedi1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Omna Trivedi |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesiology
1st floor A-Block
AIIMS Bathinda
Mandi Dabwali Road
151001
Department of Anaesthesiology
1st floor A-Block
AIIMS Bathinda
Mandi Dabwali Road
151001
Bathinda
PUNJAB
151001
India |
| Phone |
8830172361 |
| Fax |
|
| Email |
omnatrivedi1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Omna Trivedi |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesiology
1st floor A-Block
AIIMS Bathinda
Mandi Dabwali Road
151001
Department of Anaesthesiology
1st floor A-Block
AIIMS Bathinda
Mandi Dabwali Road
151001
Bathinda
PUNJAB
151001
India |
| Phone |
8830172361 |
| Fax |
|
| Email |
omnatrivedi1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
1st floor A-Block
AIIMS Bathinda
Mandi Dabwali Road
Punjab, India
151001 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bathinda |
| Address |
PG Hostel
AIIMS Bathinda
Mandi Dabwali Road
151001 |
| 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 Omna Trivedi |
AIIMS Bathinda |
Department of Anaesthesiology
1st floor A-Block
AIIMS Bathinda
Mandi Dabwali Road
151001
Bathinda
PUNJAB |
8830172361
omnatrivedi1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Adults between the age of 18-70 years posted for elective abdominopelvic laparoscopic surgery.
b) ASA physical status I, II or III.
|
|
| ExclusionCriteria |
| Details |
a) Refusal to provide informed consent.
b) Patients with a history suggestive of glaucoma, any active ocular infection or any ocular injury.
c) Patients with history suggestive of any intra-cranial pathology.
d) Conversion of laparoscopic procedure into open surgery intra-operatively due to any reason. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Optic Nerve Sheath Diameter |
T1 - before induction
T2 – after intubation
T3 – before insufflation
T4 – after insufflation
T5 – after exsufflation
T6 – after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic Parameter |
T1 - before induction of anaesthesia (baseline).
T2 – after securing the airway.
T3 – five minutes after intubation but before insufflation to create pneumoperitoneum.
T4 – after insufflation and stabilization of pneumoperitoneal pressure at IAP of 12 mm Hg.
T5 – after exsufflation of pneumoperitoneum.
T6 – after extubating the trachea of the patient. |
| ONSD changes in Patients intubated with endotracheal tube vs supraglottic airway device |
T1 - before induction of anaesthesia (baseline).
T2 – after securing the airway.
T3 – five minutes after intubation but before insufflation to create pneumoperitoneum.
T4 – after insufflation and stabilization of pneumoperitoneal pressure at IAP of 12 mm Hg.
T5 – after exsufflation of pneumoperitoneum.
T6 – after extubating the trachea of the patient. |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/06/2024 |
| Date of Study Completion (India) |
09/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Summary:
Aim: The aim of the study is to evaluate changes in optic nerve sheath diameter (ONSD) using ultrasound (USG) at specific time points during laparoscopic abdominopelvic surgeries under general anesthesia.
Primary Objectives: 1. Assess changes in ONSD with variations in intra-abdominal pressure (IAP) during laparoscopic surgeries. 2. Measure ONSD before induction of anesthesia (T1), after airway securing (T2), five minutes later (T3), after insufflation of pneumoperitoneum (T4), after exsufflation of pneumoperitoneum (T5), and after tracheal extubation (T6).
Secondary Objectives: 1. Compare ONSD measurements between patients intubated with endotracheal tube and those using a supraglottic airway device. 2. Ensure patients’ safety and monitor vital signs throughout the procedure.
Intervention Technique: Patients will follow pre-operative fasting guidelines and receive standard pre-operative preparation. ONSD measurements will be taken using USG. Anesthesia induction will be done with appropriate medications, and airway secured with an endotracheal tube or supraglottic airway device. ONSD measurements will be taken at specific time points intraoperatively. General anesthesia will be maintained, and ONSD measurements will be repeated after key surgical steps. Abnormal ONSD measurements will prompt ophthalmological evaluation postoperatively. |