| CTRI Number |
CTRI/2024/03/063695 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of positive pressure on ventilator in operative period on intracranial pressure during laparoscopic gynecological surgeries. |
|
Scientific Title of Study
|
Effect of positive end-expiratory pressure on intracranial tension during
laparoscopic gynecological surgeries. A Randomised controlled trial. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Sonker Shastri |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anesthesiology
Fifth Floor OT Complex
Phulwari Sharif
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
8800620254 |
| Fax |
|
| Email |
vaibhavsonker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajnish Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anesthesiology
Room No 503B5A
Fifth Floor OT Complex
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drrajnishkumar@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rajnish Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anesthesiology
Room No 503B5A
Fifth Floor OT Complex
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drrajnishkumar@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology 5th floor, OT Complex, All India Institute Of Medical Science Patna |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Department Of Anesthesiology,Room no:- 503 b block ot complex. 5th floor ipd bulding, Phwarisharif,AIIMS Patna |
| 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 |
| Dr Vaibhav Sonker Shastri |
All India Institute Of Medical Sciences, Patna |
Department Of Anesthesiology, 5th floor OT Complex, IPD Bulding, Phulwari Sharif, Aiims Patna.
Patna
BIHAR |
8800620254
vaibhavsonker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Aiims Patna |
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 |
Effect of Positive End-Expiratory Pressure on Intracranial Tension |
Effect of 0, 5, 8 Positive End-Expiratory Pressure on Intracranial Tension via Change in Optic Nerve Sheath Diameter at T0-5 minutes after induction of general anesthesia.
T1-10 minutes after patient is placed in pneumoperitoneum and change in position (trendelenburg position of 30
degree).
T2-30 minutes after pneumoperitoneum and change in position (trendelenburg position of 30 degree).
T3-5 minutes after desufflation once patient had become supine. |
| Intervention |
Effect Of Positive End-Expiratory Pressure On Intracranial Tension |
T0-5 minutes after induction of general anesthesia:
T1-10 minutes after patient is placed in pneumoperitoneum (PP) and change in position (trendelenburg position of 30
degree):
T2-30 minutes after pneumoperitoneum (PP) and change in position (trendelenburg position of 30 degree):
T3-5 minutes after desufflation once patient had become supine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patient aged 18-60 years, ASA 1 and 2 scheduled for laparoscopic gynecological surgeries |
|
| ExclusionCriteria |
| Details |
Patient aged less than 18 and more 60 years, ASA 3 and 4, patient refusal for study, patient having previous history and ongoing ocular disease or taking medication for ocular disease, patients with neurological disease and transient ischemic attack, patient who had elevated IOP or ICP, patient who are converted to open surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of 5 cm and 8 cm of water positive end expiratory pressure (PEEP)
versus Zero PEEP (ZEEP) application on the optic nerve sheath diameter. |
Optic Nerve Sheath Diameter: T0-5 minutes after induction of general anesthesia.
T1-10 minutes after patient is placed in pneumoperitoneum and change in position.
T2-30 minutes after pneumoperitoneum
T3-5 minutes after desufflation once patient had become supine. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in optic disc elevation with PEEP of 0 cm, 5 cm and 8 cm water. |
from 5 minutes after induction of general anesthesia to 5 minutes after desufflation once patient had become supine. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
14/03/2024 |
| 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
|
In laparoscopic gynecological surgery there is prolonged pneumoperitoneum and trendelenburg position (head down) over 30 degrees for surgical exposure. In patients undergoing laparoscopic surgeries under anesthesia, there is a triple compartment involvement, increased intra-abdominal pressures due to pneumoperitoneum, increased intra thoracic pressures due to intermittent positive pressure ventilation (IPPV) results in an increased intra cranial pressure. Many studies have suggested an increased PEEP to improve lung function, however the dangers of increasing PEEP on the intra cranial pressures, have not been studied especially in gynaecological laparoscopic surgeries, where steep head down position is given. |