| 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
|
|
|
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
|
|
|
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. |