FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068231 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 02/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the impact of two different anaesthetic agents on diameter of the Optic Nerve Sheath during Laparoscopic Surgeries. 
Scientific Title of Study   An Open Labelled Randomized Controlled Trial to compare the effect of Desflurane and Target Controlled Infusion of Propofol on Optic Nerve Sheath Diameter in patients undergoing Laparoscopic Procedures 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naveena H 
Designation  Junior Resident 
Affiliation  Bharati Vidyapeeth University 
Address  3rd Floor, MOT Complex, Department of Anesthesiology, Bharati Hospital, Dhankawadi, Pune- 43, Maharashtra

Pune
MAHARASHTRA
411043
India 
Phone  8589068156  
Fax    
Email  naveena.h143@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalyani Nilesh Patil 
Designation  Professor 
Affiliation  Bharati Vidyapeeth University 
Address  3rd Floor, MOT Complex, Department of Anesthesiology, Bharati Hospital, Dhankawadi, Pune- 43, Maharashtra

Pune
MAHARASHTRA
411043
India 
Phone  9673400066  
Fax    
Email  kalyanish19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalyani Nilesh Patil 
Designation  Professor 
Affiliation  Bharati Vidyapeeth University 
Address  3rd Floor, MOT Complex, Department of Anesthesiology, Bharati Hospital, Dhankawadi, Pune- 43, Maharashtra

Pune
MAHARASHTRA
411043
India 
Phone  9673400066  
Fax    
Email  kalyanish19@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Bharati Vidyapeeth (Deemed to be) University Medical College, Pune, Maharashtra- 411043, India 
 
Primary Sponsor  
Name  Bharati Vidyapeeth (Deemed to be) University Medical College, Pune 
Address  Bharati Vidyapeeth Campus, Pune - Satara Road,Dhankawadi, Pune 411043 
Type of Sponsor  Private 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 
Dr Kalyani Nilesh Patil  Bharati Hospital  Department of Anaesthesia, 3rd floor major operation Complex
Pune
MAHARASHTRA 
9673400066

kalyanish19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth (Deemed to be) University Medical College, Institute 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  Effect of Desflurane on optic nerve sheath diameter in patients undergoing laparoscopic surgeries.  After tracheal intubation, anaesthesia will be maintained with Desflurane within the rage of 4%-7%. ONSD will be measured after induction, 10 minutes after insufflation, first hour, second hour, third hour after insufflation and final reading will be taken after desufflation. 
Comparator Agent  Effect of target controlled Propofol on optic nerve sheath diameter in patients undergoing laparoscopic surgeries.  After tracheal intubation, anaesthesia will be maintained with Propofol through Target Controlled Infusion (TCI) System. The effect site concentration of Propofol will be maintained at 3- 4 microgram/ml. ONSD will be measured after induction, 10 minutes after insufflation, first hour, second hour, third hour after insufflation and final reading will be taken after desufflation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA I, II, in the group of 18-60 years, posted foe elective laparoscopic surgeries under general Anaesthesia 
 
ExclusionCriteria 
Details  Patient refusing for the study
Patients with existing neurological diseases
eye disease like glaucoma, lens opacity or trauma.
Pre- existing raised ICP
History of Craniotomy
Pregnancy, breast feeding patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Desflurane and Target Controlled Infusion of Propofol on Optic Nerve Sheath Diameter in patients undergoing Laparoscopic surgeries.  ONSD will be measured in both the groups of patients after induction, 10 min,1 hour, 2 hour, 3 hour after Co2 insufflation and final reading will be taken after desufflation. 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the change in Optic Nerve Sheath Diameter with End Tidal Carbon dioxide concentration (EtCo2)  EtCo2 will be measured along with ONSD after induction, 10 min, 1 Hour, 2 Hour, 3 Hour after CO2 insufflation and final reading will be taken after desufflation. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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   Phase 2 
Date of First Enrollment (India)   13/06/2024 
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="1"
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  

Laparoscopic surgery is rapidly growing alternative technique to conventional open surgery for many types of surgical procedures because of it’s minimum blood loss, minimal invasiveness, less post operative pain and a consequent earlier discharge.

Despite many advantages of laparoscopic procedures the disadvantages of elevated intracranial pressure (ICP) and intra ocular pressure (IOP) remains which caused by steep angle of Trendelenberg position and the induced Co2 pneumoperitoneum.

Laparoscopy involves Co2 insufflation to create pneumoperitoneum for enhancement of operative visual field and often steep head-down position (up to 45 degree Trendelenberg position).

This Co2 gets absorbed in systemic circulation and arterial levels of Co2 increased. Co2 insufflation during pneumoperitoneum creation is associated with physiological changes resulting in a typical state of increased IOP during laparoscopic surgery.

There are various methods for detection of intracranial pressure both invasive and non invasive.

•       Invasive methods are costly require special precautions and strict neurological settings associated with serious complications like brain damage, hemorrhage, infection.

•       There are non invasive methods like cranial CT, MRI, USG. Amongst non invasive methods USG guided ONSD is the best.

Ultrasonographic measurement of the optic nerve sheath diameter (ONSD) is simple, non invasive, and accurate ICP assessment technique. Ultrasound of 6-15 Hz high frequency probe is used for ONSD measurement.

 

AIM

To compare the effect of Desflurane and target controlled infusion of Propofol on optic nerve sheath diameter in patients  undergoing laproscopic surgeries

OBJECTIVES :

Primary Objective: To compare the effect of Desflurane and target controlled infusion of Propofol on optic nerve sheath diameter in patients  undergoing laproscopic surgeries.

Secondary Objective: To correlate the change in optic nerve sheath diameter with end tidal carbondioxide concentration (EtCo2)


METHODOLOGY

The patients will be informed about the study in a language they fully comprehend. The patient will be enrolled in the study after taking a written informed consent. A computer - generated table of random numbers will be used randomly to divide the patients into two groups : Patients that will receive inhalational anesthesia with Desflurane (Group I) and patients that will receive propofol- based TIVA (Group II) . After identification, On arrival into the operating room patient’s baseline parameters will be recorded. I.V Line to be secured. Glycopyrrolate (0.2mg) and midazolam (0.05mg/kg) will be administered before induction of anaesthesia in both groups.

In Group I patients, Patients  will be  oxygenated with 100% Oxygen for 3 minutes. General anaesthesia is induced with 1.5mg/kg propofol , 2mcg/kg fentanyl  and muscle relaxation will be achieved with IV atracurium 0.5mg/kg. Following tracheal intubation, anaesthesia will be maintained  with Desflurane. The end –tidal concentration of desflurane will be maintained  within the range of 4%-7%. In Group II patients, after tracheal intubation, anesthesia will be maintained with Propofol through Target Controlled Infusion (TCI) system. Patient’s ONSD will be measured in both eyes using 7.5 MHz Linear Ultrasound probe. ONSD will be measured  after induction (T0), 10 min after insufflation (Ti), 1st Hour, 2nd Hour, 3rd Hour, 4th Hour (T1, T2, T3, T4 respectively). Final reading will be taken after desufflation. Respiratory parameters (Peak airway pressure, End- tidal CO2) along with ONSD. 


 

 
Close