| CTRI Number |
CTRI/2025/02/080632 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING THE EFFECT OF TWO MEDICATIONS DEXMEDETOMIDINE AND MAGNESIUM SULPHATE ON HOW QUICKY ATRACURIUM TAKES EFFECT,MEASURED USING A TRAIN OF FOUR NEUROMUSCULAR MONITOR |
|
Scientific Title of Study
|
Comparing the Effect of Bolus Intravenous Dexmedetomidine Vs Magnesium Sulphate On Onset of Atracurium using a TOF Monitor-A Randomised Controlled 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.Harshanaa.G |
| Designation |
Postgraduate,Department of Anaesthesiology |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai, Kelambakkam - 603 103, Chennai, Tamil Nadu, India.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9176258393 |
| Fax |
|
| Email |
harshanaa.g@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Anand.S |
| Designation |
Professor,Department of Anaesthesiology |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai, Kelambakkam - 603 103, Chennai, Tamil Nadu, India.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9444486183 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Harshanaa.G |
| Designation |
Postgraduate,Department of Anaesthesiology |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai, Kelambakkam - 603 103, Chennai, Tamil Nadu, India.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9176258393 |
| Fax |
|
| Email |
harshanaa.g@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Academy of Research and Education,Rajiv Gandhi Salai, Kelambakkam - 603 103, Chennai, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
DR ANAND S |
| Address |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam |
| Type of Sponsor |
Other [Self] |
|
|
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 Harshanaa G |
Chettinad Academy of Research and Education |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam
Kancheepuram
TAMIL NADU |
9176258393
harshanaa.g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMITTEE FOR STUDENT RESEARCH (CARE-IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (3) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, (4) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, (5) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (6) ICD-10 Condition: K40-K46||Hernia, (7) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine
Magnesium sulphate
Atracurium
TOF monitor |
Dexmedetomidine/MagnesiumSulphate through intravenous route
Dexmedetomidine 0.5mcg/kg i.v
Magnesium sulphate 50mg/kg i.v
Connect to train of four monitor and check time taken for value to change from from 4 to 0 |
| Comparator Agent |
Dexmedetomidine
Magnesium sulphate
Normal saline |
1.Inj Dexmedetomidine 0.5mcg/kg i.v in 100ML Normal saline for 10mins.
2.Inj.Magnesium sulphate 50mg/kg i.v in 100ml normal saline for 10 mins
3. 100ml normal saline for 10 mins
Connect train of four monitor. Check the time taken for reading to change from 4 to 0 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. ASA Grade I and Grade II patients
b. Age 18 yrs-60yrs.
c. Elective surgeries |
|
| ExclusionCriteria |
|
|
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 |
| Time required for TOF value to change from 4 to 0 |
Baseline
After drug changes
Pre intubation
Post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time required for TOF value to change from 0 to 1 |
30 mins,45 mins,60 mins |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
05/03/2025 |
| 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="0"
Months="4"
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 - NO
|
|
Brief Summary
|
•Muscle
relaxation is an important component in delivering of anesthesia.
Non-depolarizing neuromuscular blocking agents are widely used in maintenance
of the neuromuscular relaxation.
•MgSO4, which acts as an antagonist at
N-methyl-D-aspartate receptors, has an
effect on neuromuscular transmission. •It potentiates the
neuromuscular block produced by nondepolarizing neuromuscular blocking agents. •Alpha2-
adrenergic agonists like Dexmedetomidine potentiate NMBA action by increasing
NMBA plasma concentration •Our
goal is to compare the onset of action of Atracurium using a TOF monitor after
a bolus of Dexmedetomidine or Magnesium Sulphate during induction and compare with a control group.
|