| CTRI Number |
CTRI/2025/07/091816 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Dexmedetomidine on Succinylcholine-Induced Fasciculation and Myalgia during Anaesthesia in ENT surgeries |
|
Scientific Title of Study
|
Effect of infusion of Dexmedetomidine on Succinylcholine induced fasciculation and myalagia during General Anaesthesia in ENT surgeries |
| 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 kavya praneetha |
| Designation |
PG resident (Anaesthesia) |
| Affiliation |
Jawaharlal Nehru Institute of Medical Sciences |
| Address |
Department of Anaesthesia, AVBRH, DMIHER,Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9133291675 |
| Fax |
|
| Email |
kolakavyapraneetha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drjayashree sen |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Institute of Medical Sciences |
| Address |
Department of Anaesthesia, AVBRH, DMIHER,Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09813061192 |
| Fax |
|
| Email |
Jayashree_sen@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kavya praneetha |
| Designation |
PG resident (Anaesthesia) |
| Affiliation |
Jawaharlal Nehru Institute of Medical Sciences |
| Address |
Department of Anaesthesia, AVBRH, DMIHER,Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09813061192 |
| Fax |
|
| Email |
kolakavyapraneetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research Wardha |
| Address |
Department of Anaesthesia AVBRH DMIHER Wardha |
| 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 kavya praneetha |
Jawaharlal Nehru Institute of Medical Sciences |
Department of Anaesthesia, AVBRH, DMIHER,Wardha
Wardha
MAHARASHTRA |
09133291675
kolakavyapraneetha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine Group |
The administration of intravenous dexmedetomidine (0.5 µg/kg diluted in 20 ml of saline over 10 minutes) in 30 patients was done to evaluate its effectiveness in reducing succinylcholine-induced fasciculations and postoperative myalgia during general anesthesia in ENT surgeries. |
| Comparator Agent |
Saline Group |
30 patients received 20 ml of plain normal saline infusion over 10 minutes using a syringe pump, serving as the placebo control before anesthesia premedication. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Weighing between 40- 80 kg
Without comorbidities
Scheduled for elective short duration surgeries under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Hypertension or ischemic heart disease
Increased intracranial or intraocular pressure
Anticipated difficult airways according to LEMON criteria
Pregnant or currently breastfeeding women
Diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence and severity of fasciculations after succinylcholine administration, assessed using Mingus ML grading scale.
Incidence and severity of post-operative myalgia (POM) at 30 and 45 minutes post-extubation, assessed using Harvey et al. grading scale. |
Incidence and severity of fasciculations after succinylcholine administration, assessed using Mingus ML grading scale.
Incidence and severity of post-operative myalgia (POM) at 30 and 45 minutes post-extubation, assessed using Harvey et al. grading scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic changes (Heart Rate, SBP, DBP, MAP) at baseline and various time points (T1-T6).
Quality of intubation conditions (satisfactory, fair, poor).
Incidence of adverse effects such as hypotension, bradycardia, nausea, vomiting, and need for intervention.
Requirement for additional neuromuscular blockade agents (vecuronium administration and dose adjustments).
Post-operative analgesic requirement and need for additional pain management.
Let me know if you need any modifications or additions. |
At intra op and 30 and 45 minutes post-extubation, |
|
|
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)
|
15/08/2025 |
| 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="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 - NO
|
|
Brief Summary
|
This is study protocol study has not been started |