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
|
|
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
|
|
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 procedurePatient 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 managementPre-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 collectionThe 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 |