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
|
|
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
|
|
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 |