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CTRI Number  CTRI/2018/07/014970 [Registered on: 19/07/2018] Trial Registered Prospectively
Last Modified On: 24/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Intravenous fluid - Ringer Lactate]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Prevention of low blood pressure in patients undergoing neck spine surgery for long-standing compression of spinal cord. 
Scientific Title of Study   Effect of fluid pre-loading on hypotension following induction of general anaesthesia in patients with chronic cervical myelopathy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anto Paul 
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, Bangalore, 560029

Bangalore
KARNATAKA
560029
India 
Phone  91-9446217922  
Fax    
Email  drantopaul@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhusudan Reddy 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bangalore, 560029

Bangalore
KARNATAKA
560029
India 
Phone  91-9880103088  
Fax    
Email  krmsr2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sriganesh K 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bangalore, 560029

Bangalore
KARNATAKA
560029
India 
Phone  91-9481445949  
Fax    
Email  drsri23@rediffmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, 560029 
 
Primary Sponsor  
Name  Anto Paul 
Address  Senior Resident, Department of Neuroanaesthesia and Neurocritical Care, NIMHANS, Bangalore, 560029 
Type of Sponsor  Other [SELF] 
 
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 
Anto Paul  National Institute of Mental Health And NeuroSciences.  Neurocentre operation theatres , Department of Neuroanaesthesia and Neurocritical Care, NIMHANS,BANGALORE, 560029
Bangalore
KARNATAKA 
91-9446217922

drantopaul@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
Modification(s)  
Health Type  Condition 
Patients  chronic cervical myelopathy, (1) ICD-10 Condition: M471||Other spondylosis with myelopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous fluid - Ringer lactate   Intravenous fluid pre-loading with 20 ml/kg of Ringer lactate over 30 minutes prior to induction of anaesthesia, followed by 2ml/kg/h maintenance 
Comparator Agent  Intravenous fluid - Ringer lactate  Intravenous infusion of Ringer lactate at 2ml/kg/h prior to induction of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Evidence of cervical myelopathy clinically or on imaging studies for more than three months and posted for surgery
2. American Society of Anaesthesiologists Class 1 - 2
 
 
ExclusionCriteria 
Details  1. AtlantoAxial Dislocation and Cervico-Medullary Junction lesion
2. Tumour pathology
3. Pre-existing systemic disease on treatment - Diabetes Mellitus, COPD, Hypertension, Ischemic heart disease, Cardiac dysfunction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
hypotension after induction of general anaesthesia for surgery in patients with chronic cervical myelopathy  Pre-intervention, Post-intervention, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 5 minutes after positioning for surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters following induction in patients with chronic cervical myelopathy  Pre-intervention, Post-intervention, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 5 minutes after positioning for surgery. 
Effect of autonomic dysfunction on post induction hypotension and autonomic function changes during and following induction using the ANS index.  Pre-intervention, Post-intervention, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 5 minutes after positioning for surgery 
Effect of hypotension on cerebral oxygen saturation (cSO2).  Pre-intervention, Post-intervention, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 5 minutes after positioning for surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/08/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Statement of Problem

During anaesthesia induction, cervical myelopathy patients have higher risk of developing hemodynamic changes due to ANS dysfunction and can result in spinal cord ischemia. Effect of fluid pre-loading on hemodynamics in patients with chronic cervical myelopathy during anaesthesia induction is unknown. Effect of post-induction hypotension on cSO2 is also unknown.

Aims and objectives

Primary objective: To assess the effect of fluid pre-loading before induction of general anaesthesia, on the incidence of post-induction hypotension in patients with chronic cervical myelopathy

Secondary objective:

1.      To assess the effect of fluid pre-loading before induction of general anaesthesia, on the hemodynamic parameters following induction in patients with chronic cervical myelopathy

2.      To evaluate the effect of autonomic dysfunction on post induction hypotension and autonomic function changes during and following induction using the ANS index.

3.      To assess effect of hypotension on cerebral oxygen saturation (cSO2).

Study procedure

Patient details like age, sex, height, weight, BMI would be collected. Preoperative data including heart rate, Blood pressure, cardiac output, total peripheral resistance, blood oxygen saturation, ANS index, cerebral oxygen saturation would be collected using noninvasively placed patient monitors including NICOM, ANSiscope, and NIRS.

Following this patients in Group F would receive 20 ml/kg of Ringer lactate over 30 minutes prior to induction of anaesthesia, followed by 2ml/kg/h maintenance. Patients in Group C would receive Ringer lactate at 2ml/kg/h prior to induction of anaesthesia.

Standardized   anaesthetic    protocol will be followed for all patients for induction and maintenance of anaesthesia. Heart rate, Blood pressure, cardiac output, total peripheral resistance, blood oxygen saturation, ANS index, cerebral oxygen saturation would be collected before induction, at 1,3 and 5 minutes after induction, and 1,3 and 5 minutes after intubation and 5 minutes after positioning. Hypotension will be treated with mephentermine 3 mg boluses (repeated every 5 min) till blood pressure returns to normal range and documented. Other  patient  data  in  the  perioperative  period  like  duration  of  surgery,  blood loss  and  blood  transfusion  details would  also  be  collected

Anaesthesia management

Pre-oxygenation will be done with a FiO2= 1.Anaesthesia will be induced with fentanyl (2mcg/kg), thiopentone (5mg/kg), preservative free lignocaine (1mg/kg).Muscle relaxation will be achieved with vecuronium (0.15mg/kg). Intubation will be done with appropriate size endotracheal tube at a minimum alveolar concentration of 1 MAC with a gaseous mixture of O2+air+Sevoflurane

Data collection

The data collected would include the following:

Demographics

Nurick’s score for severity of cervical myelopathy

Pre-intervention HR, BP, spo2, ANS Index, CO, cSO2

Post study intervention HR, BP, spo2, ANS index, CO, cSO2

Post induction - HR, BP, spo2, ANS index, CO, cSO2

Post-intubation - HR, BP, spo2, ANS index, CO, cSO2

Post- positioning- HR, BP, spo2, ANS Index, CO, cSO2

 
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