| 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
|
|
|
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
|
|
|
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. |