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CTRI Number  CTRI/2024/09/074363 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to compare supine vs trendelenburg position on optic nerve sheath diameter in laparoscopic surgery patients 
Scientific Title of Study   Comparison of supine vs trendelenburg position on optic nerve sheath diameter in laparoscopic surgery 
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 Mirley Rupinder Singh 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9814046459  
Fax    
Email  dr_mirley_rupinder_kaur@dmch.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhupen 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  8283861410  
Fax    
Email  bhupenbharti7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhupen 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  8283861410  
Fax    
Email  bhupenbharti7@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India 
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 Mirley Rupinder Singh  Dayanand Medical College and Hospital  Department of Anaesthesia, Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana 141001
Ludhiana
PUNJAB 
9814046459

dr_mirley_rupinder_kaur@dmch.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical committee, Dayanand medical college and hospital  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 
Comparator Agent  Ultrasonographic optic nerve sheath diameter measurements in supine position in laparoscopic surgery patients.  To quantitatively measure the intracranial pressure changes in supine position using optic nerve sheath diameter in patients undergoing laparoscopic surgery 
Comparator Agent  Ultrasonographic optic nerve sheath diameter measurements in trendelenberg position in laparoscopic surgery patients.  To quantitatively measure the intracranial pressure changes in trendelenburg position using optic nerve sheath diameter in patients undergoing laparoscopic surgery 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  65.00 Day(s)
Gender  Both 
Details  Adult either sex patients aged between 18 to 65 yrs of ASA grade 1to 4 planned for elective laparoscopic surgeries in trendelenburg position 
 
ExclusionCriteria 
Details  1. Patient refusal
2. History of pre-existing ophthalmic diseases (e.g. cataract, glaucoma, retinal detachment) and ophthalmic surgeries.
3. History of neurologic disease i.e. brain injury, epilepsy, parkinsonism, intracranial lesion, stroke.
4. Change of surgical plan from laparoscopic to open surgery.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is to measure the change in optic nerve sheath diameter on changing position from supine to trendelenburg position in elective laparoscopic surgeries as a surrogate marker for increased intracranial pressure.  The patients will be observed firstly in supine position at 5 mins after induction of general anaesthesia and secondly, in trendelenburg position after achieving pneumoperitoneum and third, 5 mins after turning back to supine post-surgery after desufflation of pneumoperitoneum. 
 
Secondary Outcome  
Outcome  TimePoints 
The impact of duration of trendelenburg position in surgery on optic nerve sheath diameter patients undergoing elective laparoscopic surgeries.  The patients will be observed firstly, in supine position at 5 mins after induction of general anaesthesia & secondly, in trendelenburg position after achieving pneumoperitoneum & third, 5 mins after turning back to supine postsurgery after desufflation. 
The impact of angle of trendelenburg position in surgery on optic nerve sheath diameter patients undergoing elective laparoscopic surgeries.  The patients will be observed firstly, in supine position at 5 mins after induction of general anaesthesia & secondly, in trendelenburg position after achieving pneumoperitoneum & third, 5 mins after turning back to supine postsurgery after desufflation. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   06/10/2024 
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="6"
Days="29" 
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 surgeries are widely used nowadays as an alternative over open surgeries for various procedures due to its minimal invasiveness, reduced hemorrhage risk, lower post operative pain and early discharge. However, in abdominal and laparoscopic surgeries, Trendelenburg position is often used for better surgical field exposure but postoperatively there are common incidences of delirium, cognitive dysfunction, conjunctival edema which can be attributed to increased intracranial pressure (ICP). This can result in acute rise in ICP which decreases cerebral perfusion pressure and can be deleterious increasing chances of morbidity and mortality. Thus, monitoring ICP during laparoscopic surgery might prevent such complications and enhance recovery. Thus, Optic nerve sheath diameter (ONSD) measurement with ultrasound has emerged as a simple, non-invasive and reliable surrogate of invasive ICP measurement. A prospective, randomized observational study will be conducted on a total of 40 adult patients planned for laparoscopic surgeries in trendelenburg position under general anaesthesia. The technique for general anaesthesia will be standardized in all patients. The ultrasonographic optic nerve sheath diameter measurements will be taken after 5 mins of induction in supine position and then in trendelenburg position after achieving adequate pneumoperitoneum and later after 5 mins of turning back to supine position post-surgery. Our aim of the study will be to quantitatively measure the ICP changes in supine and trendelenburg position using optic nerve sheath diameter changes in patients undergoing laparoscopic surgery and to assess effect of changing position from supine to trendelenburg position changes optic nerve sheath diameter. The primary outcome will be to measure the change in onsd on changing position from supine to trendelenburg position in elective laparoscopic surgeries as a surrogate marker for increased intracranial pressure. The secondary outcome will be the impact of duration of trendelenburg position in surgery on onsd patients undergoing elective laparoscopic surgeries and the impact of angle of trendelenburg position in surgery on onsd on changing position from supine to trendelenburg position undergoing elective laparoscopic surgeries.

 
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