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CTRI Number  CTRI/2023/08/056991 [Registered on: 28/08/2023] Trial Registered Prospectively
Last Modified On: 26/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   In this study I will be comparing the effect of priming dose(1/10th of the full dose)of Vecuronium with that of Magnesium sulphate on the onset time of intubation in patients undergoing surgeries under General Anaesthesia 
Scientific Title of Study   Comparitive study on the effect of priming dose of Vecuronium with that of Magnesium sulphate on the onset time of intubation in patients undergoing surgeries under General Anaesthesia-A prospective randomized single blinded study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AFFRIN FATHIMA K 
Designation  PG RESIDENT 
Affiliation  CHETTINAD ACADEMY OF RESEARCH AND EDUCATION 
Address  DEPARTMENT OF ANAESTHESIOLOGY,CHETTINAD ACADEMY OF RESEARCH AND EDUCATION,CHETTIAND HEALTH CITY,RAJIV GANDHI SALAI,KELAMBAKKAM,KANCHIPURAM DISTRICT

Kancheepuram
TAMIL NADU
603103
India 
Phone  8056110575  
Fax    
Email  affrnf@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DRARUN KUMAR 
Designation  PROFESSOR 
Affiliation  CHETTINAD ACADEMY OF RESEARCH AND EDUCATION 
Address  DEPARTMENT OF ANAESTHESIOLOGY,CHETTINAD ACADEMY OF RESEARCH AND EDUCATION,CHETTIAND HEALTH CITY,RAJIV GANDHI SALAI,KELAMBAKKAM,KANCHIPURAM DISTRICT

Kancheepuram
TAMIL NADU
603103
India 
Phone  8056110575  
Fax    
Email  pugalenthi08@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  AFFRIN FATHIMA K 
Designation  PG RESIDENT 
Affiliation  CHETTINAD ACADEMY OF RESEARCH AND EDUCATION 
Address  DEPARTMENT OF ANAESTHESIOLOGY,CHETTINAD ACADEMY OF RESEARCH AND EDUCATION,CHETTIAND HEALTH CITY,RAJIV GANDHI SALAI,KELAMBAKKAM,KANCHIPURAM DISTRICT

Kancheepuram
TAMIL NADU
603103
India 
Phone  8056110575  
Fax    
Email  affrnf@gmail.com  
 
Source of Monetary or Material Support  
Chettinad hospital and research institute 
 
Primary Sponsor  
Name  CHETTINAD HOSPITAL AND RESEARCH INSTITUTE 
Address  Chettinad health city,D block,1st floor,Rajiv gandhi salai,Kelambakkam-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 
DR AFFRIN FATHIMA K  CHETTINAD ACADEMY OF RESEARCH AND EDUCATION  Department of Anaesthesiology,D block,1st Floor,Chettinad academy of research and education,Chettinad health city,Rajiv gandhi salai,Kelambakkam,Kanchipuram
Kancheepuram
TAMIL NADU 
8056110575

affrnf@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chettinad Academy and Research institute - Institutional human ethics commitee for student research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj.Vecuronium with that of Inj.Magnesium sulphate   Effect of priming doses of Inj.Vecuronium with that of Inj.Magnesium sulphate on the onset time of intubation in patients undergoing surgeries under General Anaesthesia.Patients will receive 0.01mg/kg of vecuronium iv 4 minutes prior to loading dose of 0.09 mg/kg iv.To compare the onset of time of intubation  
Comparator Agent  Inj.Vecuronium with that of Magnesium sulphate   Patients will receive 50 mg/kg of magnesium sulphate 10 mins prior to loading dose of 0.1 mg/kg of Effect of priming dose of Vecuronium with that of Magnesium sulphate on the onset time of intubation in patients undergoing surgeries under General Anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.American Society of Anaesthesiologists (ASA) 1,2,3
2.Age group between 18 to 60 years of both sexes
3.Patients posted scheduled for elective surgeries under General anaesthesia
4.Mallampatti Grade 1,2,3
5.BMI < 30
 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Anticipated difficult intubation
3.BMI > 30
4.If patient allergic to study drugs
5.Emergency surgeries
6.Pregnant patients
7.Patients with significant hepatic,renal,metabolic,neuro muscular disorder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of priming dose of vecuronium with that of MgSo4 on the onset time of intubation in patients undergoing surgeries under General anaesthesia  Before induction till the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the duration of vecuronium in all 3 groups
2.To look for ease of intubation
3.To observe haemodynamic response in all groups
4.To look for any side effects
 
Before induction till the end of surgery 
 
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   N/A 
Date of First Enrollment (India)   04/09/2023 
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 
Estimated Duration of Trial   Years="1"
Months="11"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Introduction:

Rapid sequence intubation(RSI) usually applies when tracheal intubation must be performed in a patient whom is suspected to have a full stomach and patient who is at high risk of pulmonary aspiration of gastric contents.The RSI goal is to secure the airway without producing any vomiting or regurgitation.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.Vecuronium, is a cardiac stable, mono-quarternary, steroidal, non depolarizing muscle relaxant, competitive neuromuscular inhibitor which has been shown to provide adequate intubating conditions with slower onset of action(3 to 5minutes),intermediate duration(25 to 30mts) and no side effects.Priming is the administration of one tenth of the intubating dose of non depolarizing blocker few minutes before the full intubating dose.The concept of priming technique is that the initial 1/10th of non depolarizing muscle relaxant occupies and blocks large number of acetylcholine receptors before apparent clinical reduction in neuromuscular transmission.Hence the 2nd dose blocks the remaining receptor leading to rapid onset of intubation.Many studies have proved that this approach hastens the onset of non depolarising muscle relaxants.Magnesium potentiates neuromuscular blockade through inhibition of calcium mediated release of acetylcholine from pre-synaptic nerve terminals at the neuromuscular junction and also a decrease in post synaptic sensitivity to acetylcholine and direct effects on the membrane potential of myocytes, thus augmenting the effect of non depolarizing neuromuscular blockade.MgSo4 pre treatment should reduce the onset time of vecuronium induced block to an extent that makes it an alternative to succinylcholine for rapid sequence intubation.After pre treatment with Magnesium sulphate (MgSo4),an increased speed of onset and prolongation of the recovery period of neuromuscular end plate is both time dependent & concentration dependent in patients using Vecuronium for RSI. The study comparing Magnesium sulphate with vecuronium are very limited, hence in this study we are comparing the effect of priming dose of vecuronium with that of MgSo4 on the onset time of intubation in patients undergoing surgeries under General anaesthesia

AIM & OBJECTIVES: 

   

Aim:

Our study is to compare the effect of priming dose of Vecuronium with that of Magnesium sulphate on the onset time of intubation in patients undergoing surgeries under General Anaesthesia

 

Objectives:

Primary Objective:

Ø To compare the onset of time of intubation among the 3 groups

Secondary Objective:

Ø To compare the duration of vecuronium in all 3 groups

Ø To look for ease of intubation

Ø To observe haemodynamic response in all groups

Ø To look for any side effects like muscle weakness,oliguria,ptosis,difficulty in swallowing,breathing difficulty.

 

Review Of Literature: 

1.    Nalini KB et al.,[1] conducted a randomized trial of pretreatment of magnesium sulphate accelerates neuromuscular block as compared to vecuronium priming using 120 patients, which has 3 groups- 40 each.  Group-N: They were randomly allocated to control, received 100mcg/kg vecuronium after saline infusion.  Group-P: vecuronium priming, received 10 mcg/kg vecuronium followed by 90 mcg/kg vecuronium.  Group-M: Magnesium group, patients were infused with 40 mg/kg magnesium sulphate followed by 100 mcg/kg vecuronium.  This study conclude that pretreatment of magnesium infusion accelerates the onset of action of neuromuscular blockers and prolongs their duration of action.

 

2.    Vimala et al.,[2] conducted a study on Rapid sequence intubation using vecuronium in 70 patients, which has seven groups of ten patients each were studied. One group, the “standard” group, was given succinylcholine, 1.5 mg/kg, for tracheal intubation.  The remaining six groups received vecuronium according to the dose. This study concludes Intubating conditions were not satisfactory within 60 sec when a single large dose (150 mcg/kg) of vecuronium was used. Only six of ten patients could be intubated in 60 sec. When a priming dose of vecuronium was used 5 min before the total dose, all the patients could be intubated in 60 sec. Only five of the ten patients given 7 mcg/kg priming.

 

3.    T. Fuchs-Buder et al.,[3] studied about Interaction of magnesium sulphate with vecuronium induced neuromuscular block in 125 patients.  Part-1 (60 patients) for dose response.  Group-A: 30 patients - received MgSO4 40 mg/kg  in saline as an i.v. infusion over 15 min.  Group-B: 30 patients received the same volume of saline without MgSO4.  This study concluded that the neuromuscular potency of vecuronium was increased markedly by MgSO4.

 

4.    Tassonyi et al.,[4]  conducted a study on Magnesium sulphate enhances residual neuromuscular block induced by vecuronium in 30 patients.  2 groups: 15 each.  Group A: iv MgSo4 60mg/kg given 1 min before giving rocuronium 0.6mg/kg.  Group B: iv normal saline given 1 min before giving rocuronium 0.6mg/kg.  This study concluded that prior administration of magnesium sulphate, prolonged rocuronium-induced neuromuscular block but did not increase speed of onset.

 

5.    Okuda et al.,[5] conducted a study on pretreatment with magnesium sulphate enhances vecuronium-induced neuromuscular block.  This study has 2 groups.  Group-A: iv MgSO4 (20 or 40 mg/kg) with vecuronium.  Group-B: iv normal saline with vecuronium.  He concluded that the neuromuscular effect of vecuronium was not influenced by pretreatment with MgSO4 20 mg. On the contrary, the onset time of vecuronium was decreased and the duration of action until 25% recovery was increased by pretreatment with MgSO4 40 mg.

 

 

JUSTIFICATION:

 

At a priming dose of 0.01mg/kg, the onset time of intubation with vecuronium is same as that of succinyl choline (60 seconds)

There are no significant studies done comparing the priming effect of Vecuronium with that of MgSo4 on the onset time of intubation

 

 

 

METHODS:

 

Study Population:

            Study population consists of ASA 1,2,3 patients scheduled for elective surgery under General Anaesthesia

Study Design:

            This study will be designed as a prospective, randomized, single blinded, controlled study

 

SAMPLE SIZE:

Sample size suggested for the present study is 20 in each group

Each group has 20 patients

Ø Group 1: n=20                    

            Patients will receive 0.01mg/kg of vecuronium 4 minutes prior to loading dose of 0.09 mg/kg

Ø Group2: n=20

              Patients will receive 50 mg/kg of magnesium sulphate 10 mins prior to loading dose of 0.1 mg/kg of vecuronium

Ø Group3: n=20

             Infusion of 100ml normal saline will be given over 10 mins prior to induction with 0.1 mg/kg of vecuronium, will be considered as the control group.

 

MATERIALS & METHODS:

 

•        Study type: Interventional

•        Study design: Prospective, Randomised, Single blinded study

•        Study population: After obtaining Ethical Committee approval and CTRI registration, 60 patients who will undergo elective surgeries at Chettinad Hospital and Research Institute, Kelambakkam, Chengelpet, will be taken up for study.

•        Inclusion Criteria:

Ø American Society of Anaesthesiologists (ASA) 1,2,3

Ø Age group between 18 to 60 years of both sexes

Ø Patients posted scheduled for elective surgeries under General anaesthesia

Ø Mallampatti Grade 1,2,3

Ø BMI < 30

•        Exclusion Criteria:

Ø Patient refusal

Ø Anticipated difficult intubation

Ø BMI > 30

Ø If patient allergic to study drugs

Ø Emergency surgeries

Ø Pregnant patients

Ø Patients with significant hepatic,renal,metabolic,neuro muscular disorder

 

METHODOLOGY:

After obtaining approval by the Institutional Human Ethics Committee and CTRI registration, and written informed patient consent, 60 patients under ASA physical status I,II,III patients scheduled for elective surgeries, will be included in a prospective, randomized, single-blinded clinical trial at Chettinad Hospital and Research Institute, Kelambakkam, Chennai.

Patients with anticipated difficult airway, risk of aspiration, renal or cardiac disease will excluded from this study

In the preoperative assessment, detailed history and physical examination, baseline data like pulse rate, blood pressure, SpO2 and basic investigations will be collected.

Informed and written consent will be obtained

All patients were kept by Nil Per Oral for about 8 hours prior to surgery and will be premedicated with Tab.Alprazolam0.5mg & Tab.Ranitidine150mg will be given the previous night of surgery & morning of surgery

IV access will be secured for all patients with 18G iv cannula

On arrival to operation theatre, standard monitoring of pulse oximetry, Non invasive blood pressure (NIBP), continuous electrocardiogram (ECG) will be established and baseline variable values will be noted before the procedure.

TOF watch will be connected in the wrist to look for adductor pollicis action.

Patient will receive Inj.Midazolam1mg iv 15minutes prior to induction

The study drug will be given as per the selected time period (Either 4minutes or 10minutes)

After 3minutes of Pre oxygenation with 100% O2

Anaesthesia will be induced with fentanyl2mcg/kg, propofol2mg/kg

The response of the 1st dorsal interosseous muscle of hand to supramaximal Train Of Four (TOF) stimulation of ulnar nerve at the wrist at 20sec intervals measured electromyographically

Remaining dose of vecuronium 0.1mg/kg as neuromuscular agent will be given

Speed of onset will be determined with TOF (Train Of Four)

After the TOF becomes zero, a Senior anaesthesiologist will perform the intubation

Another anaesthesist will assess the onset time, intubating conditions and clinical duration of neuromuscular block in different groups.

The onset time of intubation will be noted.Onset time is defined as the time from the injection of the intubating dose of muscle relaxant to the time when all 4 twitches disappeared.Is recorded in seconds

The duration of muscle relaxation is also monitored.Duration time is defined as the time from the injection of intubating dose of muscle relaxant to the time when the first twitch reappeared.Is recorded in minutes.

Anaesthesia will be maintained with Isoflurane 1-2% in Oxygen and Nitrous oxide.Maintainance dose of vecuronium of 0.01 to 0.015 mg/kg will be required every 30 to 40 minutes

Ease of intubation will be graded with Cooper scoring system

 Haemodynamic changes will be monitered and noted till the end of surgery.

 

 

 

 

 

 

Cooper Scoring System:

SCORE

JAW RELAXATION

VOCAL CORDS

RESPONSE TO INTUBATION

0

Impossible to open

Closed/Bucking

Severe coughing

1

Opens with difficulty

Closing

Mild coughing

2

Moderate opening

Moving

Slight diaphragmatic movement

3

Easy opening

Open

No movement

 

§  8-9 Excellent

§  6-7 Good

§  3-5 Fair

§  0-2 Poor

 

 

REFERENCE:

1.    Pretreatment of magnesium sulphate accelerates neuromuscular block as compared to vecuronium priming – A randomized trial Nalini KB1,*, Muralidhar Danappa Patel2 , Pandya Khushal3

2.    Rapid sequence intubation using vecuronium - Vimala E.Kunjappan MD,Eli M.Brown MD and Gaylord D.Alexander MD

3.    Interaction of magnesium sulphate with vecuronium induced neuromuscular block - T. FUCHS-BUDER, O. H. G. WILDER-SMITH, A. BORGEAT AND E. TASSONYI

4.    Magnesium sulphate enhances residual neuromuscular block induced by vecuronium T. FUCHS-BUDER AND E. TASSONYI

5.    Pretreatment with magnesium sulphate enhances vecuronium-induced neuromuscular block. Okuda T 1, Umeda T, Takemura M, Shiokawa Y,KogaY

 

 

 

 

 


 
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