CTRI Number |
CTRI/2022/10/046194 [Registered on: 06/10/2022] Trial Registered Prospectively |
Last Modified On: |
04/10/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
to study the effect of different pressures of air in the abdomen during laparoscopic surgery on the diameter of covering around the nerve that connects eye to brain |
Scientific Title of Study
|
The effect of different pressures of pneumoperitoneum on the optic nerve sheath diameter (ONSD) - prospective study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
SUPRAJA PONDURU |
Designation |
senior resident |
Affiliation |
Esic medical college and hospital |
Address |
Department of anaesthesiology, esic medical college and hospital, sanath Nagar Sanath Nagar Hyderabad TELANGANA 500038 India |
Phone |
08500974476 |
Fax |
|
Email |
supraja.suneel16@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Ananya nanda |
Designation |
Assistant professor |
Affiliation |
Esic medical college and hospital |
Address |
Department of anaesthesiology, esic medical college and hospital, sanath Nagar Sanath Nagar Hyderabad TELANGANA 500038 India |
Phone |
8179654082 |
Fax |
|
Email |
nanda.ananya@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Ananya nanda |
Designation |
Assistant professor |
Affiliation |
Esic medical college and hospital |
Address |
Department of anaesthesiology, esic medical college and hospital, sanath Nagar Sanath Nagar Hyderabad TELANGANA 500038 India |
Phone |
8179654082 |
Fax |
|
Email |
nanda.ananya@gmail.com |
|
Source of Monetary or Material Support
|
Esic medical college and hospital, sanathnagar, Hyderabad, Telangana, pincode 500038. |
|
Primary Sponsor
|
Name |
Esic medical college and hospital |
Address |
Department of anaesthesiology, esic medical college and hospital,
sanathnagar, hyderabad, pincode 500038 |
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 |
supraja ponduru |
Esic medical college and hospital |
Department of anaesthesiology, esic medical college and hospital, sanathnagar Hyderabad TELANGANA |
8500974476
supraja.suneel16@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: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
low pressure pneumoperitoneum of 6-8mmHg |
we plan to study effect of low pressure pneumoperitoneum of 6-8mmHg on the intracranial pressure by measuring optic nerve sheath diameter using ultrasound as a non invasive approach |
Intervention |
standard pressure pneumoperitoneum of 13-15mmHg |
we plan to study the effect standard pressure pneumoperitoneum of 13-15mmHg on intracranial pressure by measuring optic nerve sheath diameter using ultrasound as a non invasive approach |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. ASA physical status I and II.
2. Age between 18 –60 years.
3. The patients scheduled for elective laparoscopic surgery under general anesthesia.
4. Informed written consent
|
|
ExclusionCriteria |
Details |
1. Patient refusal.
2. ASA group 3 and 4, Emergencies
3. Pregnancy
4. Patients with head injury, space occupying lesions of brain
5. Cases converted to open laparotomy
• Patients with any significant systemic illness
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
measurement of optic nerve sheath diameter (ONSD) as a noninvasive alternative to intracranial pressure (ICP) |
intraoperatively |
|
Secondary Outcome
|
Outcome |
TimePoints |
hemodynamics |
intraoperatively |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
10/10/2022 |
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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Laparoscopic surgery is a unique, minimally invasive technique and a key tool in various therapeutic and diagnostic procedures. In performing this minimal access procedure carbon dioxide (CO2) pneumoperitoneum is created for visualization and to allow surgical manipulation. Increased intra-abdominal pressure (IAP) and CO2 gas during pneumoperitoneum leads to various systemic changes involving cardiovascular, respiratory and cerebral physiology. Though these physiological changes well tolerated by healthy individuals, may have adverse consequences in elderly with borderline organ function and critically ill patients. Conventional method of gas insufflation during laparoscopic surgeries leads to IAP of 12-16 mmHg (standard IAP). It was emphasized that with low pressure pneumoperitoneum (IAP <10mmHg) there is less postoperative pain, better hemodynamics, reduced surgical events and also has neuro-protective effect. Several studies documented the effect of raised IAP on intra cranial pressure (ICP). The mechanisms of increase of ICP during laparoscopy may be due to increase IAP impeding drainage of the lumbar venous plexus, impairment of cerebrospinal fluid (CSF) absorption and cerebral vasodilation due to hypercarbia. Raised ICP may cause significant neurological complications. Various methods are used in measuring ICP, which are invasive and time consuming. The optic nerve sheath is in continuity with the dura mater, surrounded by subarachnoid space which is continuous with intracranial subarachnoid space. So any change in ICP is transmitted to optic nerve sheath. Optic nerve sheath diameter (ONSD) measured by ultrasonography a non-invasive imaging technique, is a safe and accurate method in diagnosing increased ICP. In our study we plan to investigate the effect of standard (13-15mmHg) and low (6-8mmHg) pressure pneumoperitoneum on intracranial pressure (ICP) using ultrasound measurements of optic nerve sheath diameter (ONSD). |