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Clinical Trial Details (PDF Generation Date :- Mon, 08 May 2023 13:57:47 GMT)

CTRI Number CTRI/2018/01/011484 [Registered on: 23/01/2018] - Trial Registered Retrospectively

Last Modified On 19/01/2018
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Drug
Surgical/Anesthesia
Study Design Randomized, Parallel Group Trial
Public Title of Study A Clinical trial to study the effects of three different doses of Magnesium Sulphate in decreasing
Succinylcholine induced fasciculations
Scientific Title of Efficacy of Magnesium Sulphate in attenuation of Succinylcholine induced fasciculations- A Dose
Study finding study
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Bala Bhaskar S
Trial Coordinator
(multi-center study) Designation Professor
Affiliation Vijayanagar Institute of Medical Sciences
Address Dep of Anaesthesia, VIMS Ballari Karnataka
Bellary
KARNATAKA
India
India
Phone 0839235275
Fax
Email [email protected]
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Dr Vedashree Y
Query)
Designation Post Graduate Student
Affiliation Vijayanagar Institute of Medical Sciences
Address Dep of Anaesthesia, VIMS Ballari Karnataka
Bellary
KARNATAKA
India
India
Phone 8050203933
Fax
Email [email protected]
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Bala Bhaskar S
Designation Professor
Affiliation Vijayanagar Institute of Medical Sciences
Address Dep of Anaesthesia, VIMS Ballari Karnataka
Bellary
KARNATAKA
India
India
Phone 0839235275
Fax

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Email [email protected]
Source of Monetary or Source of Monetary or Material Support
Material Support
> Vijayanagar institute of medical sciences Cantonment, Ballari, Karnataka 583104
Primary Sponsor Primary Sponsor Details
Name VIMS Ballari
Address VIMS Ballari 583104
Type of Sponsor Government medical college
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Balabhaskar S Vijayanagar institute of Dep Anaesthesia VIMS 9880012349
medical sciences Ballari
Bellary [email protected]
KARNATAKA m
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Vijayanagar Institute of Approved 20/03/2017 No
Medical Sciences VIMS
Ethics Committee
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Patients posted for surgeries under genera l
anesthesia and receiving Succinyl choline
Intervention / Type Name Details
Comparator Agent
Comparator Agent Group 1 MgSO4 at 20mg/kg IV diluted in
10ml NS administored over 10
minutes
Intervention Group 2 MgSO4 at 30mg/kg IV diluted in
10ml NS administored over 10
minutes
Intervention Group 3 MgSO4 at 40mg/kg IV diluted in
10ml NS administored over 10
minutes
Inclusion Criteria Inclusion Criteria
Age From 20.00 Year(s)
Age To 50.00 Year(s)
Gender Both
Details Patients posted to elective surgery under general anesthesia,
belonging to ASA I and II
Exclusion Criteria Exclusion Criteria
Details Patient refusal, history of signifcant systemic disordess, preexisting
musculo skeletal disorders, allergy to test drugs,already on
magnesium therapy, pregnant patients
Method of Generating Computer generated randomization
Random Sequence

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Method of Sequentially numbered, sealed, opaque envelopes

Concealment
Blinding/Masking Participant and Investigator Blinded
Primary Outcome Outcome Timepoints
To compare the efficacy of three different Observed for 1 minute after administration of
pretreatment doses of magnesium sulphate in succinylcholine
reducing incidence and severity of
succinylcholine induced fasciculations.
Secondary Outcome Outcome Timepoints
Haemodynamic responses to intubation at 1,3,5 and 10 min after intubation
Target Sample Size Total Sample Size=90
Sample Size from India=90
Final Enrollment numbers achieved (Total)=90
Final Enrollment numbers achieved (India)=90
Phase of Trial N/A
Date of First 10/04/2017
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=5
Days=10
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details No publications
Brief Summary In present study the incidence of fasciculations was found to be 90%,
53.4% and 43.4% in group 1, 2 & 3 respectively. Group 1 patients had the
most intense fasciculations with 20% patients experiencing grade 3, 40%
grade 2 and 30% had grade 1 fasciculations. In group 2, 3.4% patients
experienced grade 3, 20% grade 2 and 30% had grade 3 fasciculations
whereas in group 3 no patient experienced grade 3 fasciculations, only
3.4% patients experienced grade 2 and 40% had grade 1
fasciculations which further suggests the efficacy of magnesium sulphate
in abolishing fasciculations.

Pre-administration of intravenous magnesium sulphate in doses of

30mg/kg and 40mg/kg was more effective compared to 20mg/kg in
attenuation of succinylcholine induced fasciculations. Intravenous
magnesium sulphate 30mg/kg may be the optimal dose to reduce the
incidence and severity of succinylcholine induced fasciculations. It
also attenuates the hemodynamic responses to laryngoscopy and
intubation without any significant adverse effects.

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