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CTRI Number  CTRI/2025/11/097951 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study If The Muscle Pains Caused By the Use of Succinylcholine which is used during general anaesthesia for surgical procedures Can Be Reduced By Giving Dexmedetomidine And To Study If Dexmedetomidine Causes Any Change In The Creatine Phosphokinase Levels in the blood 
Scientific Title of Study   Effects Of Dexmedetomidine On Succinylcholine-Induced Myalgia And Creatine Phosphokinase Levels In The Early Postoperative Period. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rachel B Singh 
Designation  PG Resident 
Affiliation  Christian Medical College and Hospital Ludhiana 
Address  Department of Anesthesia, Christian Medical College and Hospital Ludhiana 141008 Punjab

Ludhiana
PUNJAB
141008
India 
Phone  9465427281  
Fax    
Email  rachel.phillip@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dootika Liddle 
Designation  Professor and Head 
Affiliation  Christian Medical College and Hospital Ludhiana 
Address  Department of Anesthesia, Christian Medical College and Hospital Ludhiana 141008 Punjab

Ludhiana
PUNJAB
141008
India 
Phone  9815484085  
Fax    
Email  dootika.liddle@cmcludhiana.in  
 
Details of Contact Person
Public Query  
Name  Rachel B Singh 
Designation  PG Resident 
Affiliation  Christian Medical College and Hospital Ludhiana 
Address  Department of Anesthesia, Christian Medical College and Hospital Ludhiana 141008 Punjab


PUNJAB
141008
India 
Phone  9465427281  
Fax    
Email  rachel.phillip@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Christian Medical College and Hospital Brown Road Ludhiana 141008 
 
Primary Sponsor  
Name  Rachel B Singh 
Address  Christian Medical College and Hospital Brown Road Ludhiana 141008 Punjab 
Type of Sponsor  Private medical college 
 
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 
Rachel B Singh  Christian Medical College and Hospital   Department of Anaesthesia First Floor
Ludhiana
PUNJAB 		 9465427281

rachel.phillip@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% Normal Saline  0.9% Normal Saline 100 ml will be given over 10 minutes before induction of anaesthesia 
Intervention  Dexmedetomidine  1 microgram per kg of dexmedetomidine in 100 ml of normal saline over 10 minutes before induction of general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgery (defined as a procedure that is not an emergency and can be scheduled in advance) under general anaesthesia.
American Society of Anesthesiologists (ASA) I & II.

 
 
ExclusionCriteria 
Details  Any contraindications to general anesthesia.
Sensitivity or allergy to any of the study drugs.
Pregnancy.
Patients with elevated CPK levels pre-operatively – polytrauma, Crush injuries.
Morbid obesity.
Patients on anti-psychotic medication.
History of masseter spasm (Malignant Hyperthermia).
 
 
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 
Dexmedetomidine helps reduce the myalgia caused by succinylcholine administered during induction of general anesthesia.  Immediate post operatively and 24 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Succinylcholine causes mylagia which can be correlated with rise in creatine phospokinase levels in the serum  Immediate Pre-operative and 24 hours post-operative. 
 
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)   05/12/2025 
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="0"
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
    Response -  Analytic Code

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

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

  5. By what mechanism will data be made available?
    Response (Others) -  Publisher link under open access license

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 01-12-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Succinylcholine chloride is a short acting depolarizing neuromuscular blocking agent. It is used to expedite rapid sequence endotracheal intubation and facilitate surgical procedures. However, it has a few reported adverse effects including fasciculations, postoperative myalgia, and an increase in serum Creatine phosphokinase. Dexmedetomidine is an alpha 2 receptor agonist with a notable anti-inflammatory response, which may diminish the succinylcholine-induced myalgia and the rise in Creatine phosphokinase. 
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