A comparative study in acheiv ing rapid onset intubation with different types of muscle relaxant(Rocuronium) with or without adjuvant(Magnesium sulphate)

Phase 4

Not yet recruiting

Conditions: Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,

Registration Number: CTRI/2025/04/085837

Lead Sponsor: Chettinad hospital and research insititute

Brief Summary: Emergency intubation is becoming very common in anaesthesia,emergency medicine and critical care practice. Intubation is performed fasterin order to avoid complications like hypoxia and aspiration. Administration ofneuromuscular blockade is essential for most of the cases. Succinylcholinewhich is a depolarising muscle relaxant is the gold standard neuromuscularblocking agent in rapid sequence intubation. Due to its side effects,other nondepolarizing muscle relaxants such as atracurium and vecuronium when used withrecommended dosage for intubation has developed rapid sequence intubation 2-3minutes later than that of succinylcholine. Non depolarising muscle relaxantwith low potency has rapid onset of action. Many studies has shown that inspite of rapid onset, mivacurium didn’t produce satisfactory results. Studieson Rocuronium showed that as the intubating dose increased, the duration ofaction also increased proportionately. Rocuronium dose of 0.6 mg/kg hasobtained intubation conditions within 60-90 seconds and has a duration ofaction 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 onsetof action closer to succinylcholine. Magnesium has found to potentiate theeffect of non-depolarising muscle relaxants and could shorten the onset oftime. This study is to evaluate the effect of magnesium pretreatment onrocuronium priming in achieving rapid onset of intubation conditions andevaluation of conditions during the same.

Study Objectives

Primary objective To compare the efficacy of magnesiumpretreatment on rocuronium priming to reduce the onset time ofintubation.

Secondary objective To assess the intubating conditionsusing Cooper’s scoring system. To observe the duration of rocuronium inducedneuromuscular block after pretreatment with magnesium sulfate.

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

Number of subjects/sample size The calculated samplesize 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 andneuro muscular disorders.

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

Methodology

A routine preoperative examination is done prior tothe day of surgery.

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

Prior to shifting the patient inside the operationtheatre,the anaesthesia machine, laryngoscope with Macintosh blade ofappropriate size,working suction apparatus and drug tray are checked.

Once the patient is shifted inside the Ot,standardmonitoring such as,ECG, non invasive blood pressure,SPO2 and end tidal carbondioxide( ETCO2) are attached. A 18G cannula is secured and an infusion of 100mlNS placebo(group A)/with Magnesium sulfate(50mg/kg)(Group B)is infused over 10minutes.Hemodynamic parameters like heart rate, systolic and diastolic bloodpressure are recorded at baseline. Inj.Fentanyl 2mcg/kg IV given. After 10minutes 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/kgIV is given before a further dose of rocuronium 0.45mg/kg(intubating dose).

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

Study outcome or end points This study will be used toinvestigate whether onset of neuromuscular blockade was shortened bycombination of Magnesium pretreatment with rocuronium priming,compared withrocuronium priming alone.

References

1. The Effect of Magnesium Sulphate Pre-Treatment onRocuronium Priming in Achieving Rapid Onset of Intubating Conditions NirmalSheshagiri\*, Khalid Zahir, Lokesh Reddy, Salman Mohammad Kutty, Surjya KantaMohanty and https://juniperpublishers.com/jaicm/pdf/JAICM.MS.ID.555693.pdfSupriya Preman

2. Comparison of intubating conditions between rocuroniumwith priming and without priming: Randomized and double-blind study MHanumantha 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, magnesiumpre-treatment and a combination of the two methods. DOI:https://pubmed.ncbi.nlm.nih.gov/22420830/

4. Comparison of Magnesium Pre-treatmentWith Two Different Doses of Rocuronium in Rapid Sequence Intubation: ARandomized 2024Cureus 16(3):e56794DOI:10.7759/cureus.56794 ControlledTrial.March

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1 ASA grade 1 and 2 patients.
2 Age 18-70 years.
3 Mallampatti class 1 and 2.

Exclusion Criteria

Refusal of consent.
Known or anticipated difficult airway.
Pregnant patients 4.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of magnesium pretreatment on rocuronium	30 minutes
priming to reduce the onset time of intubation.	30 minutes

Secondary Outcome Measures

Name	Time	Method
To assess the intubating conditions using Cooper’s scoring system.	To observe the duration of rocuronium induced neuromuscular block after

Trial Locations

Locations (1): Chettinad hospital and research insitute
🇮🇳
Chennai, TAMIL NADU, India
Chettinad hospital and research insitute
🇮🇳Chennai, TAMIL NADU, India
DrDhanya G
Principal investigator
09791882791
ammudhanya96@gmail.com