| CTRI Number |
CTRI/2017/10/010068 [Registered on: 12/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of two different anaesthesia drugs on the increase in diameter of the optic nerve in robotic pelvic surgery
|
|
Scientific Title of Study
|
To compare the increase in optic nerve sheath diameter during propofol versus sevoflurane-maintained anaesthesia in robotic-assisted laparoscopic pelvic
surgery
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nambiath Sujata |
| Designation |
Senior Consultant |
| Affiliation |
Max Superspeciality Hospital |
| Address |
A 325, FF Shivalik
Department of Anesthesia and Pain management, No. 1 Press Enclave road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9999109402 |
| Fax |
|
| Email |
drnambiath@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nambiath Sujata |
| Designation |
Senior Consultant |
| Affiliation |
Max Superspeciality Hospital |
| Address |
A 325, FF, Shivalik
Department of Anesthesia and Pain management,
Max Hospital, No. 1 Press Enclave road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9999109402 |
| Fax |
|
| Email |
drnambiath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nambiath Sujata |
| Designation |
Senior Consultant |
| Affiliation |
Max Superspeciality Hospital |
| Address |
A 325, FF, Shivalik
Department of Anesthesia and Pain management,
Max Hospital, No. 1 Press Enclave road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9999109402 |
| Fax |
|
| Email |
drnambiath@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Max Superspeciality Hospital |
| Address |
No. 1 Press Enclave road, Saket, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nambiath Sujata |
Max Super Speciality Hospital |
First floor, West block, Department of Anesthesia and pain management
South
DELHI |
9999109402
drnambiath@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
| Max Healthcare Ethics Committee |
Approved |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Scheduled for robotic assisted pelvic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol |
Given intravenously, dose titrated to maintain BIS 40 to 60 |
| Comparator Agent |
Sevoflurane |
Given by inhalational route. Inspired concentration titrated to maintain BIS 40 to 60 |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled for robotic - assisted pelvic surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal, history of raised intracranial or intraocular pressure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change from baseline of the sonographically measured ONSD during propofol versus sevoflurane maintained anesthesia in patients undergoing robotic-assisted laparoscopic pelvic surgery. |
Preoperative, 10 minutes postinduction of anaesthesia, post docking (30min, 1 hour, 2 hours, 3 hours, 4 hours and 5 hours), 30 min after undocking and 30 min after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To find out any intragroup correlation in the propofol group between the total dose of propofol used and the change in ONSD from the baseline.
2) To find out the correlation between the change in ONSD from the baseline and the duration of surgery.
|
End of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/10/2015 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. BACKGROUND OF TRIAL Robotic-assisted laparoscopic pelvic surgery requires a much steeper Trendelenburg position and a higher pressure of CO2 pneumoperitoneum than in other conventional or laparoscopic surgeries. Retroperitoneal dissection also increases the absorption of CO2 . This causes several physiological changes like raised airway, abdominal, intraocular and intracranial pressures (ICP) . Raised ICP can severely compromise the cerebral perfusion pressure leading to ischemia of the brain parenchyma. Ultrasonography of ONSD shows a good level of diagnostic accuracy for detecting intracranial hypertension . Hence ONSD can be used as a surrogate for direct measurement of ICP. Both propofol and volatile anesthetics are commonly used for maintenance of anesthesia in patients undergoing robotic surgery in steep trendelenburg position. However, it has been shown in neurosurgical patients that mean ICP values are lower and cerebral perfusion pressures values higher with propofol-maintained anesthesia . PURPOSE OF TRIAL In our study, we aim to compare the increase in optic nerve sheath diameter from the baseline during propofol versus sevoflurane-maintained anesthesia in robotic-assisted laparoscopic pelvic surgery. The purpose of the study is to find out whether propofol or sevoflurane based anaesthesia maintains the intracranial pressure more optimally in robotic assisted pelvic surgeries. AIMS AND OBJECTIVES Primary Objective: To compare the change from baseline of the sonographically measured ONSD during propofol versus sevoflurane maintained anesthesia in patients undergoing robotic-assisted laparoscopic pelvic surgery. Secondary Objectives: 1) To find out any intragroup correlation in the propofol group between the total dose of propofol used and the change in ONSD from the baseline. 2) To find out the correlation between the change in ONSD from the baseline and the duration of surgery.
|