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CTRI Number  CTRI/2025/07/091537 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Effects of Dexmedetomidine on Prevalence of Succinylcholine induced Fasciculations and Postoperative Myalgia A Randomized, controlled, double blinded study 
Scientific Title of Study   Effects of dexmedetomidine on prevalence of succinylcholine induced fasciculations and post operative myalgia A randomized , controlled, double blinded study 
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 Sahil Khatri 
Designation  Post Graduate Resident  
Affiliation  School of medical sciences and research sharda hospital sharda university  
Address  Department of Anaesthesia School of medical sciences and research Sharda Hospital Sharda University Knowledge park 3 GB nagar Greater noida Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9971948270  
Fax    
Email  sahilkhatri98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahendra Kumar 
Designation  Professor  
Affiliation  School of Medical Sciences and Research Sharda hospital Sharda University  
Address  Department of Anaesthesia School of medical sciences and research Sharda Hospital Sharda University Knowledge park 3 GB nagar Greater noida Uttar Pradesh


UTTAR PRADESH
201306
India 
Phone  8287188449  
Fax    
Email  mahendra.kumar@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shivika Nath 
Designation  Associate Professor  
Affiliation  School of Medical Sciences and Research Sharda hospital Sharda University  
Address  Department of Anaesthesia School of medical sciences and research Sharda Hospital Sharda University Knowledge park 3 GB nagar Greater noida Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9999096812  
Fax    
Email  shivika.nath@sharda.ac.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology School of medical sciences and research Sharda hospital Sharda University  
 
Primary Sponsor  
Name  Department of Anaesthesia School of medical sciences and research Sharda University  
Address  Knowledge park 3 Greater Noida GB nagar uttar pradesh 
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 
Dr Mahendra Kumar  Department of Anaesthesia sharda hospital  School of medical sciences and research Sharda university knowledge park 3 greater noida
Gautam Buddha Nagar
UTTAR PRADESH 
8287188449

mahendra.kumar@sharda.ac.in 
 
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 
Intervention  Dexmedetomidine  Patients of this group will receive Inj Dexmedetomidine 0.25mcg per kg body weight in 100 ml saline over a period of 15 mins intravenously before induction of anaesthesia 
Comparator Agent  Normal saline   Patients of this group will receive Inj normal saline 100 ml Normal saline over a period of 15 mins intravenously before induction of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients scheduled for any elective surgery under general
anaesthesia with endotracheal intubation
ASA class I and II
Age 18-60 years
Both genders 
 
ExclusionCriteria 
Details  Patients already taking steroids or analgesics or antiemetic and
sedatives preoperatively for any clinical condition
Patients with past history of chronic pain
Patients having history of endocrine or cardiovascular or renal or
CNS disease
Patients allergic to study drugs
Contraindication of succinylcholine for example High potassium level extensive burn renal failure or soft tissue injury
BMI more than 30 kg meter square  
 
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 
Prevalence of Succinylcholine induced
Postoperative Myalgia following intravenous administration of
Dexmedetomidine 
Perioperative  
 
Secondary Outcome  
Outcome  TimePoints 
To observe and compare the grades of fasciculations and Postoperative
Myalgia
To compare the changes in the levels of serum potassium
To find out the relationship between fasciculations and serum
potassium levels and myalgia
To compare the heart rate and systolic blood pressure in two groups 
Perioperative  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   02/08/2025 
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 - NO
Brief Summary  

This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of Dexmedetomidine on Succinylcholine-induced fasciculations and postoperative myalgia in adult patients undergoing elective surgeries under general anesthesia. Succinylcholine, though widely used for rapid sequence intubation due to its fast onset and short duration, is associated with side effects like muscle fasciculations and postoperative muscle pain, which can impact patient satisfaction and recovery. Dexmedetomidine, an alpha-2 adrenergic agonist with sedative, analgesic, and sympatholytic properties, is hypothesized to reduce these adverse effects due to its pharmacological profile. Participants are randomly allocated into two groups: one receiving intravenous Dexmedetomidine before Succinylcholine administration and the other receiving a placebo. Parameters including the incidence and severity of fasciculations, as well as the intensity and duration of postoperative myalgia, will be assessed and compared between the two groups. The primary objective is to determine whether Dexmedetomidine pre-treatment can provide a clinically significant reduction in Succinylcholine-induced complications, thereby enhancing the safety and comfort of patients undergoing surgery.

 
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