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CTRI Number  CTRI/2025/02/079834 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effect of low dose noradrenaline infusion on neuromonitoring in patients undergoing spine surgeries  
Scientific Title of Study   The effect of low dose noradrenaline infusion on SSEP and MEP monitoring in patients undergoing spine surgeries:A randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PITTALA SUVANI  
Designation  DNB ANAESTHESIA  
Affiliation  Yashoda hospital secunderabad  
Address  Department of Anaesthesia Third floor Room no.5 Yashoda Hospital Secunderabad

Hyderabad
TELANGANA
500003
India 
Phone  9951505509  
Fax    
Email  psuvani1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR VISHWANATH BHAIRE 
Designation  SENIOR CONSULTANT NEUROANAESTHESIA 
Affiliation  Yashoda hospital secunderabad  
Address  Department of Neuroanaesthesia Third floor Room no.1 Yashoda Hospital Secunderabad

Hyderabad
TELANGANA
500003
India 
Phone  9914015533  
Fax    
Email  vishwasb216@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR VISHWANATH BHAIRE 
Designation  SENIOR CONSULTANT NEUROANAESTHESIA 
Affiliation  Yashoda hospital secunderabad  
Address  Department of Neuroanaesthesia Third floor Room no. 1 Yashoda Hospital Secunderabad

Hyderabad
TELANGANA
500003
India 
Phone  9914015533  
Fax    
Email  vishwasb216@gmail.com  
 
Source of Monetary or Material Support  
Yashoda Hospital Secunderabad,TELANGANA 500 003, INDIA 
 
Primary Sponsor  
Name  Yashoda hospital, Secunderabad 
Address  Yashoda Hospital, Behind Harihara Kala Bhawan, S.P.Road, Secunderabad, Telangana-500003 
Type of Sponsor  Private hospital/clinic 
 
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 
DR P SUVANI  Yashoda Hospital secunderabad   Department of neuroanesthesia,3rd floor,Neuro OT
Hyderabad
TELANGANA 		 9951505509

psuvani1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Yashoda academy of medical education and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator agent here in our trial will be normal NS (Placebo)  The group S will receive normal saline upon start of anesthesia and continued throughout the surgery.Amplitude and latency of SSEP and MEP, NIBP,MAP,HR,are recorded every 15 minutes throughout the surgery.  
Intervention  Patients Undergoing spine surgery will receive lowdose noradrenaline or placebo according to their group   We divide patients into two groups N and S.Test drug infusion will be commensed upon start of anesthesia and continued throughout the surgery. Group N will receive low dose noradrenaline and Group S will receive normal saline. Amplitude and latency of SSEP and MEP, SBP,MAP,HR recorded every 15 minutes throughout the surgery.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed Spinal Pathology for surgery 
 
ExclusionCriteria 
Details  Patient refusal, history of epilepsy, existing motor weakness, patients with pacemakers, renal dysfunction, respiratory dysfunction, history of stroke 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of low dose noradrenaline on amplitude and latency of SSEP and MEP in IONM   18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess hypotensive episodes
To assess the requirement of rescue drugs in both groups  		 18 months 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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   Phase 2 
Date of First Enrollment (India)   15/02/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [psuvani1997@gmail.com].

  6. For how long will this data be available start date provided 07-12-2026 and end date provided 07-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A randomized double blinded control trial to study the effect of low dose noradrenaline infusion on neuro monitoring in patients under going spine surgeries for a period of 18 months. The primary aim is to assess the effect of low dose noradrenaline on the amplitude and latency of SSEP and MEP in IONM and secondary aim is to assess hypotensive episodes and requirement of rescue drugs in both groups. 
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