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CTRI Number  CTRI/2023/11/060020 [Registered on: 20/11/2023] Trial Registered Prospectively
Last Modified On: 16/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Changes in optic nerve sheath diameter during keyhole procedures in heads-down position -A prospective observational study 
Scientific Title of Study   Changes in optic nerve sheath diameter during laparoscopic procedures in trendelenburg position-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  Mary Anne Joseph  
Designation  Post Graduate  
Affiliation  St Johns medical college and hospital  
Address  Department of Anaesthesiology St Johns medical college and hospital Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9846824659  
Fax    
Email  maryanne2195@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikram M Shivappagoudar 
Designation  Associate professor 
Affiliation  St Johns medical college and hospital  
Address  Department of Anaesthesiology St Johns medical college and hospital Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9731981665  
Fax    
Email  doc_vikram@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikram M Shivappagoudar 
Designation  Associate professor 
Affiliation  St Johns medical college and hospital  
Address  Department of Anaesthesiology St Johns medical college and hospital Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9731981665  
Fax    
Email  doc_vikram@yahoo.com  
 
Source of Monetary or Material Support  
St Johns medical college and hospital Sarjapur road Bengaluru, Karnataka, 560034  
 
Primary Sponsor  
Name  Mary Anne Joseph 
Address  Post graduate Department of Anaesthesiology St Johns medical college and hospital  
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mary Anne Joseph  St Johns medical college and hospital  Department of Anaesthesiology Sarjapur road Bengaluru 560034
Bangalore
KARNATAKA 
9846824659

maryanne2195@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: C61||Malignant neoplasm of prostate, (4) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, (5) ICD-10 Condition: N51||Disorders of male genital organs in diseases classified elsewhere, (6) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I and ASA II patients
Scheduled for elective or emergency laparoscopic surgeries in trendelenburg position
 
 
ExclusionCriteria 
Details  Patients with previous history of ocular disease, ocular surgery, glaucoma
Patients with previous history of neurologic disease, transient ischemic attack or cerebrovascular disease in the past 3 months
Patients with any intracranial pathology
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To measure the changes in optic nerve sheath diameter in patients undergoing laparoscopic surgeries in trendelenburg position  Baseline
End of surgery
Recovery
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate the changes in optic nerve sheath diameter with angulation of table in trendelenburg position
2. To correlate optic nerve sheath diameter changes with duration of pneumoperitonium & trendelenburg position
 
1. 0–15 degrees
15-30 degree
30-45 degree
greater than 45 degree
2. 0-2 hours
2-4 hours
greater than 4 hours
 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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)   26/11/2023 
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="2"
Months="0"
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  
INTRODUCTION
Laparoscopic surgeries are increasingly performed today for their perceived benefits including less trauma, reduced risk of bleeding, less pain, faster recovery, and shorter hospital stay, and favourable cosmetic outcomes As a consequence, laparoscopic surgeries have become a valid and reliable alternative to open surgery in last few decades. In order to improve the visualization of the surgical field, CO2 pneumoperitoneum (PP) and a concomitant steep head-down position Trendelenburg. (TP) are often applied to patients undergoing laparoscopic urology and gynaecology procedures. However, concomitant use of PP and TP leads to an increase in intraabdominal pressure which may further provoke many systemic physiological alterations including a decrease in venous return and increase in cerebral blood flow, intracranial pressure (ICP) and intraocular pressure. Pneumoperitoneum elevates ICP because of the increased abdominal pressure and ICP increases even further in the Trendelenburg position.
Halverson et al determined that elevation in ICP is most likely owing to impaired cerebrospinal fluid drainage at the lumbar venous plexus. Rosenthal et al. later described a two-staged mechanism of ICP elevation in laparoscopic surgery. They proposed that an increase in intraabdominal pressure due to PP compresses inferior vena cava and impairs venous drainage from the lumbar plexus. According to the authors, in addition to the compression on inferior vena cava, the increase in intraabdominal pressure elevates the diaphragm and consequently leads to an increase in intrathoracic pressure which further impairs right atrial and ventricular filling and impairs the drainage of superior vena cava. The increase in central venous pressure and the resultant decrease in drainage from lumbar plexus and central nervous system are likely to contribute to the elevation of ICP occurring during laparoscopic surgery.

NEED FOR THE STUDY
Raised intracranial pressure arising following pneumoperitoneum and Trendelenburg position is a concern and may be harmful for patients with unrecognized intracranial mass lesions. Direct ICP measurement using a small pressure-sensitive probe inserted through the skull is the gold standard for monitoring ICP. For routine surgeries, the risks of such an invasive test outweighs the benefits. Measurement of the ONSD is now emerging as a useful non-invasive surrogate marker to monitor raised ICP. This study will evaluate the effect of pneumoperitoneum and head low position on ICP by measuring the ONSD.

AIM OF THE STUDY:
To assess the effect of pneumoperitoneum and trendelenburg position on optic nerve sheath diameter in laparoscopic surgeries.

OBJECTIVES OF THE STUDY:

PRIMARY
1. To measure the changes in optic nerve sheath diameter in patients undergoing laparoscopic surgeries in trendelenburg position.

SECONDARY
1. To correlate changes in optic nerve sheath diameter with angulation of table in trendelenburg position
2.To correlate ONSD changes with duration of pneumoperitoneum and trendelenburg position.

MATERIALS AND METHODS

INCLUSION CRITERIA
1. Both males and females
2. Age 18 years and <-60 years
3. ASA I and II patients
4. Scheduled for elective emergency laparoscopic surgeries in Trendelenburg position.

EXCLUSION CRITERIA
1. Patients with previous history of ocular disease, ocular surgery, glaucoma
2. Patients with previous history of neurologic disease transient ischemic attack or cerebrovascular disease in past 3 months
3. Patients with any intracranial pathology


SOURCE OF DATA

Place of study - St John’s Medical College and Hospital, Bengaluru

Study period -24 months

METHODS

STUDY DESIGN: An observational prospective cohort study

METHODOLOGY
After obtaining IEC approval, patients who meet the inclusion criteria and consenting for the study will be enrolled. Once inside the operating room, standard monitors- electrocardiogram, pulse oximetry and non-invasive arterial pressure will be connected and baseline vitals will be recorded. Premedication will be done with glycopyrrolate, Ondansetron and midazolam Fentanyl 2 mcg per kg will be administered and 3 minutes later the first measurement of ONSD will be taken. Patient will then be induced with propofol followed by atracurium to  facilitate orotracheal intubation. Pressure control ventilation will be used and ventilator parameters will be adjusted to maintain normocapnea (35-40) Pneumoperitoneum with CO2 will be established by the surgeon within the acceptable pressure limits. Trendelenburg position will be provided when requested by the surgeon to facilitate surgical exposure and table angulation will be measured with the help of an application known as ANGLE METER. Anaesthesia will be maintained with air/oxygen/gas mixture (0.8-1 MAC of isoflurane). Morphine and paracetamol will be used for analgesia. Second measurement of optic nerve sheath diamete 
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