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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  
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 
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  
Status 
Not Applicable 
 
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).

 
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