| CTRI Number |
CTRI/2023/03/051103 [Registered on: 28/03/2023] Trial Registered Prospectively |
| Last Modified On: |
23/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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A comparative study of two different doses of magnesium sulphate pre-treatment on the onset and duration of rocuronium induced neuromuscular blockade, A randomised controlled double blinded study.
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Scientific Title of Study
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A comparative study of two different doses of magnesium sulphate pre-treatment on the onset and duration of rocuronium induced neuromuscular blockade, A randomised controlled double blinded study.
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Ramya J |
| Designation |
PG Resident |
| Affiliation |
chettinad hospital and research institute,kelambakkam,chennai. |
| Address |
Department of anaesthesiology, chettinad hospital and research institute, kelambakkam,chennai.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7708120186 |
| Fax |
|
| Email |
ramyajawahar417@gmail.com |
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Details of Contact Person
Scientific Query
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| Name |
Dr Anand |
| Designation |
Professor |
| Affiliation |
chettinad hospital and research institute,kelambakkam,chennai. |
| Address |
Department of anaesthesiology, chettinad hospital and research institute, kelambakkam,chennai.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7708120186 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Ramya J |
| Designation |
PG Resident |
| Affiliation |
chettinad hospital and research institute,kelambakkam,chennai. |
| Address |
Department of anaesthesiology, chettinad hospital and research institute, kelambakkam,chennai.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7708120186 |
| Fax |
|
| Email |
ramyajawahar417@gmail.com |
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Source of Monetary or Material Support
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| Chettinad academy of research and education. |
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Primary Sponsor
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| Name |
Dr.Anand |
| Address |
Professor,Department of Anaesthesiology, chettinad hospital and research institute, kelambakkam, chennai. |
| Type of Sponsor |
Other [self] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ramya J |
Chettinad hospital and research institute |
Department of anaesthesia, Chettinad hospital and research institute, kelambakkam, chennai.
Kancheepuram
TAMIL NADU |
7708120186
ramyajawahar417@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CARE IHEC-I |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
GROUP 1: Infusion of 50 mg/kg of magnesium sulphate will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium. |
Infusion of magnesium sulphate(50mg/kg) will be started and given over 10 minutes.
Post infusion vitals will be monitered and noted
Patient will be induced with fentanyl(2mcg/kg), propofol(2mg/kg) and rocuronium 0.6mg/kg as neuromuscular agent. Onset and duration will be monitored with train of four monitor. |
| Comparator Agent |
GROUP 2: Infusion of 60 mg/kg of magnesium sulphate will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium.
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Infusion of magnesium sulphate(60 mg/kg) will be started and given over 10 minutes.
Post infusion vitals will be monitered and noted
Patient will be induced with fentanyl(2mcg/kg), propofol(2mg/kg) and rocuronium 0.6mg/kg as neuromuscular agent. Onset and duration will be monitored with train of four monitor. |
| Comparator Agent |
GROUP 3: Infusion of 100ml normal saline will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium. |
Infusion of 100ml Normal saline will be started and given over 10 minutes.
Post infusion vitals will be monitored and noted
Patient will be induced with fentanyl(2mcg/kg), propofol(2mg/kg) and rocuronium 0.6mg/kg as neuromuscular agent. Onset and duration will be monitored with train of four monitor. |
| Intervention |
To compare two different doses of magnesium sulphate pre-treatment on the onset and duration of rocuronium induced neuromuscular blockade. |
Infusion of magnesium sulphate will be started based on the group selected and given over 10 minutes.
Post infusion vitals will be monitered and noted
Patient will be induced with fentanyl(2mcg/kg), propofol(2mg/kg) and rocuronium 0.6mg/kg as neuromuscular agent.
The onset is determined with train of four.
Intubation will be done after the TOF becomes zero.
The duration of muscle relaxation is assessed from TOF zero till TOF becomes T1
An anaesthesiologist, blinded to the study, will perform intubation and assess the onset time, intubating conditions and clinical duration of neuromuscular block in different groups.
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and Grade II patients
Mallampatti Grade I and Grade II.
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| ExclusionCriteria |
| Details |
Refusal of consent
Known or anticipated difficult airway.
Emergency surgeries.
Pregnant patients.
Patients with a BMI of 35 or more
Patients with significant hepatic, renal, metabolic, neuro-muscular disorder
Those with allergy to Rocuronium.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To compare two different doses of magnesium sulphate pre-treatment on the onset of rocuronium induced neuromuscular blockade |
It is assessed every 30 sec with TOF monitoring.
Onset is noted when TOF becomes zero. |
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Secondary Outcome
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| Outcome |
TimePoints |
| To compare two different doses of magnesium sulphate pre-treatment on the duration of rocuronium induced neuromuscular blockade and haemodynamic changes. |
It is monitored every 2 minutes .Duration of action is determined when TOF zero becomes TOF 1 |
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Target Sample Size
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Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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01/04/2023 |
| 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 |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Not yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Rapid sequence induction usually applies when tracheal intubation must be performed in a patient who is suspected of having a full stomach and who is at risk of pulmonary aspiration of gastric contents. The goal is to secure the airway without producing any regurgitation or vomiting. The second objective involves minimization of induction–intubation interval, which means that a short-acting hypnotic agent should be administered with a rapidly acting neuromuscular-blocking agent. Rocuronium, a nondepolarizing muscle relaxant, has been shown to provide adequate intubating conditions with rapid onset, an intermediate duration and no obvious side effects. Rocuronium produces faster neuromuscular blockade compared with other nondepolarizing neuromuscular-blocking drugs. Magnesium potentiates neuromuscular blockade through the inhibition of calcium-mediated release of acetylcholine from the presynaptic nerve terminals at the neuromuscular junction and also a decrease in postsynaptic sensitivity to acetylcholine and direct effects on the membrane potential of myocytes, thus augmenting the effect of nondepolarizing neuromuscular blockers. After pre-treatment with magnesium sulphate (MgSO4), an increased speed of onset and a prolongation of the recovery period of neuromuscular blockade have been observed with atracurium and vecuronium. It may be assumed that the effect of the magnesium ion on the neuromuscular endplate is both concentration and time dependent. Magnesium infusion, rather than a bolus injection immediately before the injection of the NMBA, has an impact on neuromuscular blockade. In theory, MgSO4 pre-treatment should reduce the onset time of a rocuronium-induced block to an extent that makes it an interesting alternative to succinylcholine for rapid sequence induction. After institutional human ethical commitee approval and CTRI registration. patients with in the inclusion criteria are selected. Totally 90 patients will be participating in this study under three groups with each group containing 30 patients. GROUP 1: n=30 Infusion of 50 mg/kg of magnesium sulphate will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium. GROUP 2: n=30 Infusion of 60 mg/kg of magnesium sulphate will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium. GROUP 3: n=30 Infusion of 100ml normal saline will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium, will be considered as the control group. and the onset and duration of rocuronium induced neuromuscular blockade is noted with TOF monitor and results are noted.
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