CTRI Number |
CTRI/2018/05/013877 [Registered on: 14/05/2018] Trial Registered Retrospectively |
Last Modified On: |
06/05/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Prospective Randomization |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
To study the effect of face down position during spine surgery on intracranial pressure by noninvasive method. |
Scientific Title of Study
|
Effects of different prone patient positioning on Optic nerve sheath diameter in spine surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrAmitesh Kumar Pandey |
Designation |
Senior Resident |
Affiliation |
National Institute of Mental Health and Neurosciences |
Address |
Department of Neuroanaesthesia and Neurocritical Care,
National Institute of Mental Health and NeuroSciences,
Hosur Road, Bengaluru
Bangalore KARNATAKA 560029 India |
Phone |
8889049137 |
Fax |
|
Email |
dramiteshpandey@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrRameshVJ |
Designation |
HOD and Professor |
Affiliation |
National Institute of Mental Health and Neurosciences |
Address |
Department of Neuroanaesthesia and Neurocritical Care,
National Institute of Mental Health and NeuroSciences,
Hosur Road, Bengaluru
Bangalore KARNATAKA 560029 India |
Phone |
9844432607 |
Fax |
|
Email |
drvjramesh@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrRameshVJ |
Designation |
HOD and Professor |
Affiliation |
National Institute of Mental Health and Neurosciences |
Address |
Department of Neuroanaesthesia and Neurocritical Care,
National Institute of Mental Health and NeuroSciences,
Hosur Road, Bengaluru
Bangalore KARNATAKA 560029 India |
Phone |
9844432607 |
Fax |
|
Email |
drvjramesh@gmail.com |
|
Source of Monetary or Material Support
|
Non funded. Study conducted at National Institute of Mental Health and Neurosciences, Bangalore-560029
|
|
Primary Sponsor
|
Name |
Non funded |
Address |
NA |
Type of Sponsor |
Other [Non funded] |
|
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 |
DrAmitesh Kumar Pandey |
National Institute of Mental Health and Neurosciences |
Department of Neuroanaesthesia and Neurocritical care, Neuro centre faculty block, 3rd floor,
National Institute of Mental Health and Neurosciences,
Hosur Road, Bangalore – 560029
Bangalore KARNATAKA |
8889049137
dramiteshpandey@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
NIMHANS Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients undergoing spine surgery in prone position are at increased risk for raised intracranial pressure. These changes can be measured by sonographic measurement of optic nerve sheath diameter . , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Effect of two different prone position on optic nerve sheath diameter in patients undergoing spine surgery |
Patients will be randomized to either of the two arms based on the computer generated random numbers.
Group A: Patients undergoing surgeries in prone position
Group B: Patients undergoing surgeries in prone position with 10 degree of reverse trendelenberg
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1) ASA 1 and 2 patients undergoing elective lumbar or thoracic spine surgery
|
|
ExclusionCriteria |
Details |
1) Cervical spine surgery
2) Known H/O cardiac or respiratory disease/s
3) Known H/O glaucoma or any other ocular disease/s
4) Known H/O cervical pathologies
5) Previous or present H/O CNS pathologies /tumor
6) Suspected difficult airway
7) Diabetes mellitus
8) Short neck patients (if proper window not achieved in prone position)
9) Signs of increased ICP on fundoscopy
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1) To study the effect of prone position on ONSD in patients undergoing spinal surgeries.
2) To study the effect of reverse trendelenburg of 10 degree on the changes of ONSD. |
1) Before surgery
2) During surgery
3) After surgery |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Changes in the optic nerve sheath diameter at different patient positions over the course of surgery.
2) Changes in the hemodynamic parameters at different patient positions over the course of surgery
|
1) Supine position (TB)
2) After 10 minutes of prone positioning (TP)
3) After 2 hrs after prone positioning.
4) Every 1 hr till the completion of surgery ( T2,T3,T4,T5 and so on)
5) Immediately turning the patients to supine (TES)
6)30 minutes post surgery after giving 30 degree of head elevation (TE30)
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
25/05/2016 |
Date of Study Completion (India) |
28/12/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="7" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Proposed
study procedure:
Patients will be screened for
inclusion and exclusion criteria on the preoperative day. After a thorough
preoperative examination, patients
will be randomized to either of the two arms based on the computer generated
random numbers. The informed consent will be obtained.
Patients in both the groups will be
subjected to a standardized anesthesia technique comprising of induction with
Thiopentone sodium (4-5mg/kg i.v); analgesia with fentanyl (2mg/kg i.v);
muscle relaxation with vecuronium (0.15mg/kg I.v) and positive pressure
ventilation with O2 :Nâ‚‚O (1:1) / Sevoflurane. Maintenance of
anesthesia will be titrated with sevoflurane to achieve a target value of
0.8-1.0 MAC. Intraoperative analgesia will be provided by boluses dosing of
intravenous fentanyl of 1 mcg/kg i.v. Ventilator settings will be adjusted to maintain
end tidal carbon dioxide (EtCO2) between 35-40 mm Hg. Intubation of
patients will be done by flexometallic endotracheal tube of appropriate size
and secured properly.
Patients will be placed in prone
position in such a way that there should not be any impediment of venous
drainage from the head. Head of the patients will be turned to the left and
will be kept on gel foam ring to avoid compression on eyes by using gel foam
ring. Measurements of ONSD will be done by first on the left side and then on
the right side by rotating the head at different time points. Patients randomized
to Group A will undergo surgeries in prone position; and to Group B will
undergo surgeries in prone position with 10
degree of reverse trendelenberg. Any hypotension will be treated with
fluid bolus/mephentermine boluses to maintain normotension.
ONSD measurement
Ocular ultrasounds will be performed
by using GE Healthcare LOGIQ e (portable ultrasound system machine) with a 5–10
MHz linear probe. Scans will be performed on a closed eyelid with a conductive
gel. A linear probe will be used to obtain an axial cross-sectional image of
the optic nerve entering the fundus. The probe will be placed on the superior and lateral
margin of the orbit directed slightly inferiorly and medially to help
visualize margins of the nerve. For the purpose of safety biomechanical side
effects the mechanical index and thermal index will be reduced to 0.2 and 0.0
respectively.
The ONSD will be measured 3 mm behind
the globe in both the eyes. The ONSD measurements will be obtained averaging
three readings from each eye. After
intubation ONSD will be in the following time points
Ø Supine
position
Ø After 10
minutes of prone positioning
Ø After 2 hrs
after prone positioning followed by every 1 hr till the completion of surgery
Ø Immediately
turning the patients to supine
Ø 30 minutes
post surgery after giving 30 degree of head elevation
|