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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  
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 
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  
Status 
Not Applicable 
 
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

 
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