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CTRI Number  CTRI/2025/09/094069 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing the effects of adding dexmedetomidine to levobupivacaine versus using levobupivacaine alone for scalp nerve blocks to reduce the body stress response during skull pin placement in brain surgery 
Scientific Title of Study   COMPARISON OF EFFECTS OF DEXMEDETOMIDINE ADDED TO LEVOBUPIVACAINE VERSUS LEVOBUPIVACAINE ALONE INFILTRATION SCALP BLOCK FOR ATTENUATION OF THE HAEMODYNAMIC RESPONSE TO SKULL PIN PLACEMENT IN NEUROSURGICAL PROCEDURES A DOUBLE BLIND RANDOMISED CLINICAL 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 Maina Singh 
Designation  Professor 
Affiliation  Jawahar Lal Nehru Medical College Ajmer Rajasthan 
Address  Department of Anaesthesiology J L N Medical college Ajmer
Department of Anaesthesiology J L N Medical college Ajmer
Ajmer
RAJASTHAN
305001
India 
Phone  9414097045  
Fax    
Email  mainasingh111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maina Singh 
Designation  Professor 
Affiliation  Jawahar Lal Nehru Medical College Ajmer Rajasthan 
Address  Department of Anaesthesiology J L N Medical college Ajmer
Department of Anaesthesiology J L N Medical college Ajmer
Ajmer
RAJASTHAN
305001
India 
Phone  9414097045  
Fax    
Email  mainasingh111@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Maina Singh 
Designation  Professor 
Affiliation  Jawahar Lal Nehru Medical College Ajmer Rajasthan 
Address  Department of Anaesthesiology J L N Medical college Ajmer
Department of Anaesthesiology J L N Medical college Ajmer
Ajmer
RAJASTHAN
305001
India 
Phone  9414097045  
Fax    
Email  mainasingh111@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Jln medical College ajmer  
 
Primary Sponsor  
Name  J L N Medical college 
Address  Department of Anaesthesiology New OT 1st floor Jawaharlal nehru medical college and hospital and hospital Ajmer 305001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr SAMAY   JLN MEDICAL COLLEGE AJMER RAJASTHAN  
DR SASHI BALA   JLN MEDICAL COLLEGE AJMER RAJASTHAN  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR MAINA SINGH  Dr Komal   Department of Anaesthesiology New OT 1st floor J L N Medical college Ajmer Department of Anaesthesiology New OT 1st floor J L N Medical college Ajmer
Ajmer
RAJASTHAN 		 09414097045

mainasingh111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee Jawahar Lal Nehru Medical college and Hospital Ajmer Rajasthan   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C710||Malignant neoplasm of cerebrum, except lobes and ventricles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  all adult patients of either 18 -65 years of age belonging to American Society of Anaesthesiologist physical status (ASA PS) grading 1 and 2 schedule forelective craniotomoy requiring placement of Mayfieldskull pins under general anaesthesia  
 
ExclusionCriteria 
Details  patient refusal
patient with known allergies to study medication
patient with uncontrolled hypertension perioperative bradycardia (heart and renal disease)
patient on chronic opioid or alpha2-adrenergic agonist/antagonist therapy
pregnant or lactating 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
duration of analgesia   assessment of visual analogue score for pain in post operative period at immediately after shifting post operative unit after 1hr 2hr 3hr 4hr 6hr 8hr 10hr  
 
Secondary Outcome  
Outcome  TimePoints 
onset & duration of sensory block onset duration of motor block  assessment of sensory block using pin prick sensation assessed
assessment of motor block by modified bromage score at baseline 5mnt 10mnt 15mnt 30mnt 1hr 2hr 3hr 4hr 6hr 8hr &postoperative interval  
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [komalverma9009975490@gmail.com].

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 15-09-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Skull pin placement during brain surgery often causes significant pain and stress responses, such as increases in heart rate and blood pressure. Scalp nerve blocks with local anesthetics are commonly used to reduce this response. Levobupivacaine is a safe and effective local anesthetic, and dexmedetomidine is an adjuvant that may enhance its effect by providing better pain relief and reducing the stress response. This study aims to compare the effectiveness of levobupivacaine alone versus levobupivacaine combined with dexmedetomidine for scalp nerve blocks. The main focus is on how well each technique reduces the body’s stress response during skull pin insertion. Results may help improve patient comfort and stability during neurosurgery. 
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