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CTRI Number  CTRI/2025/04/085837 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study in acheiv ing rapid onset intubation with different types of muscle relaxant(Rocuronium) with or without adjuvant(Magnesium sulphate)  
Scientific Title of Study   A comparative study of Rocuronium priming with Magnesium Sulfate pre-treatment in Achieving Rapid Onset of Intubating conditions-A Randomised Controlled Trail. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhanya G  
Designation  Junior resident  
Affiliation  Chettinad hospital and research insitute 
Address  D block , 1st floor,Department of Anaesthesiology,Chettinad hospital and research institute,chettinad health city,Rajiv Gandhi Salai( OMR) ,kelambakkam

Chennai
TAMIL NADU
603103
India 
Phone  9791882791  
Fax    
Email  ammudhanya96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anand  
Designation  Professor  
Affiliation  chettinad hospital and research insitute  
Address  D block , 1st floor,Department of Anaesthesiology,Chettinad hospital and research institute,chettinad health city,Rajiv Gandhi Salai( OMR) ,kelambakkam

Chennai
TAMIL NADU
603103
India 
Phone  9444486183  
Fax    
Email  dranandmurugan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anand  
Designation  Professor  
Affiliation  chettinad hospital and research insitute  
Address  D block , 1st floor,Department of Anaesthesiology,Chettinad hospital and research institute,chettinad health city,Rajiv Gandhi Salai( OMR) ,kelambakkam


TAMIL NADU
603103
India 
Phone  9444486183  
Fax    
Email  dranandmurugan@gmail.com  
 
Source of Monetary or Material Support  
Chettinad hospital and Research Institute, Chettinad Health city, Rajiv Gandhi salai, Kelambakkam, Chennai, Tamilnadu 603103 
 
Primary Sponsor  
Name  Chettinad hospital and research insititute  
Address  Chettinad hospital and Research Institute, Chettinad Health city, Rajiv Gandhi salai, Kelambakkam, Chennai, Tamilnadu 603103 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrDhanya G  Chettinad hospital and research insitute  D block , 1st floor,Department of Anaesthesiology,kelambakkam
Chennai
TAMIL NADU 
09791882791

ammudhanya96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee for student research(CARE IHEC-I)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  rocuronium with magnesium sulphate   Patient will be given magnesium sulphate( 50mg/kg over 10 minutes) 30 mins before intubating the patient using rocuronium( 0.45mg/kg ) as muscle relaxant  
Comparator Agent  Rocuronium without magnesium sulphate   Patient will be given 100ml normal saline as placebo 30 minutes before intubating using rocuronium(0.45mg/kg) as muscle relaxant without magnesium sulphate  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 ASA grade 1 and 2 patients.
2 Age 18-70 years.
3 Mallampatti class 1 and 2. 
 
ExclusionCriteria 
Details  1. Refusal of consent.
2. Known or anticipated difficult airway.
3. Pregnant patients
4. Patients with BMI of 30 or more.
5. Patients with significant hepatic,renal,metabolic and neuro- muscular
disorders.
6. Patient receiving drugs like aminoglycosides, polymyxin A and B, colistin,
clindamycin, lincomycin that influence neuromuscular functions.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of magnesium pretreatment on rocuronium
priming to reduce the onset time of intubation. 
30 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the intubating conditions using Cooper’s scoring system.
To observe the duration of rocuronium induced neuromuscular block after
pretreatment with magnesium sulfate.
To evaluate the adverse effects 
60 MINS  
 
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   Phase 4 
Date of First Enrollment (India)   10/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/05/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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  

Emergency intubation is becoming very common in anaesthesia, emergency medicine and critical care practice. Intubation is performed faster in order to avoid complications like hypoxia and aspiration. Administration of neuromuscular blockade is essential for most of the cases. Succinylcholine which is a depolarising muscle relaxant is the gold standard neuromuscular blocking agent in rapid sequence intubation. Due to its side effects,other non depolarizing muscle relaxants such as atracurium and vecuronium when used with recommended dosage for intubation has developed rapid sequence intubation 2-3 minutes later than that of succinylcholine. Non depolarising muscle relaxant with low potency has rapid onset of action. Many studies has shown that in spite of rapid onset, mivacurium didn’t produce satisfactory results. Studies on Rocuronium showed that as the intubating dose increased, the duration of action also increased proportionately. Rocuronium dose of 0.6 mg/kg has obtained intubation conditions within 60-90 seconds and has a duration of action of 30-40 minutes. A priming dose of 0.06mg/kg (10% of intubating dose) & priming interval of 3 minute has been used in order to achieve an onset of action closer to succinylcholine. Magnesium has found to potentiate the effect of non-depolarising muscle relaxants and could shorten the onset of time. This study is to evaluate the effect of magnesium pretreatment on rocuronium priming in achieving rapid onset of intubation conditions and evaluation of conditions during the same.

 

 Study Objectives

 Primary objective To compare the efficacy of magnesium pretreatment on rocuronium priming to reduce the onset time of intubation. 

 

Secondary objective To assess the intubating conditions using Cooper’s scoring system. To observe the duration of rocuronium induced neuromuscular block after pretreatment with magnesium sulfate. 

                                To evaluate the adverse effects Study design A randomised, prospective, double blinded case study.

 

 Number of subjects/sample size The calculated sample size is 30 in each group. Group A-30 and Group B-30. Total of 60 samples. 

 

Study Methodology or procedure 

 

 Inclusion criteria

 ASA grade 1 and 2 patients.

 Age 18-70 years.

 Mallampatti class 1 and 2.

 

Exclusion criteria 

Refusal of consent. 

Known or anticipated difficult airway.

 Pregnant patients

 Patients with BMI of 30 or more.

 Patients with significant hepatic,renal,metabolic and neuro muscular disorders.

 Patient receiving drugs like aminoglycosides, polymyxin A and B, colistin, clindamycin, lincomycin that influence neuromuscular functions. 

 

Methodology

 A routine preoperative examination is done prior to the day of surgery.

 On night prior and at 6am on the day of surgery premedications- Tablet Alprazolam 0.5mg and Tablet Ranitidine 150mg is given to the patient.

 Prior to shifting the patient inside the operation theatre,the anaesthesia machine, laryngoscope with Macintosh blade of appropriate size,working suction apparatus and drug tray are checked. 

Once the patient is shifted inside the Ot,standard monitoring such as,ECG, non invasive blood pressure,SPO2 and end tidal carbon dioxide( ETCO2) are attached. A 18G cannula is secured and an infusion of 100ml NS placebo(group A)/with Magnesium sulfate(50mg/kg)(Group B)is infused over 10 minutes.Hemodynamic parameters like heart rate, systolic and diastolic blood pressure are recorded at baseline. Inj.Fentanyl 2mcg/kg IV given. After 10 minutes both the groups will receive 0.05mg/kg of rocuronium(priming dose) while the patient is being pre-oxygenated. After 2 minutes Inj.propofol 2mg/kg IV is given before a further dose of rocuronium 0.45mg/kg(intubating dose).

 In both the groups train of four (TOF) response to stimuli of ulnar nerve at Adductor pollicis in the forearm is monitored. Patient is Intubated using suitable endotracheal tube when the TOF ratio becomes 0 and then the anaesthesia will be maintained using isoflurane or sevoflurane Perioperative monitoring of the patient is done and when TOF >1 muscle relaxant is supplemented. 

 

 Study outcome or end points This study will be used to investigate whether onset of neuromuscular blockade was shortened by combination of Magnesium pretreatment with rocuronium priming,compared with rocuronium priming alone. 

 

 References 

 1. The Effect of Magnesium Sulphate Pre-Treatment on Rocuronium Priming in Achieving Rapid Onset of Intubating Conditions Nirmal Sheshagiri*, Khalid Zahir, Lokesh Reddy, Salman Mohammad Kutty, Surjya Kanta Mohanty and https://juniperpublishers.com/jaicm/pdf/JAICM.MS.ID.555693.pdf Supriya Preman 

2. Comparison of intubating conditions between rocuronium with priming and without priming: Randomized and double-blind study M Hanumantha Rao, Andal Venkatraman, and R Mallleswari DOI : https://pubmed.ncbi.nlm.nih.gov/22174467/

 3. M. H. Kim, A. Y. Oh, Y. T. Jeon, J. W. Hwang, S. H. Do.A randomised controlled trial comparing rocuronium priming, magnesium pre-treatment and a combination of the two methods. DOI: https://pubmed.ncbi.nlm.nih.gov/22420830/ 

 4. Comparison of Magnesium Pre-treatment With Two Different Doses of Rocuronium in Rapid Sequence Intubation: A Randomized 2024Cureus 16(3):e56794DOI:10.7759/cureus.56794 Controlled Trial.March

 
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