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CTRI Number  CTRI/2019/10/021820 [Registered on: 30/10/2019] Trial Registered Prospectively
Last Modified On: 27/10/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   We are comparing how rocuronium and vecuronium will reduce the complications of succinylcholine by giving them before it. 
Scientific Title of Study   COMPARATIVE STUDY OF PRETREATMENT OF ROCURONIUM VS VECURONIUM ON POST SUCCINYLCHOLINE COMPLICATIONS IN ELECTIVE SURGERIES.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B KRISHNA PREETHI 
Designation  JUNIOR RESIDENT 
Affiliation  Kalinga Institute of Medical Sciences 
Address  department of Anaesthesiology 3RD FLOOR KIMS AND PBMH PATIA, BHUBANESHWAR
KIMS
Khordha
ORISSA
751024
India 
Phone  9618846462  
Fax    
Email  doctorkrishnapreethi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR DEBASIS DEBATA 
Designation  ASSISTANT PROFESSOR 
Affiliation  Kalinga Institute of Medical Sciences 
Address  department of Anaesthesiology 3RD FLOOR KIMS AND PBMH PATIA, BHUBANESHWAR

Khordha
ORISSA
751024
India 
Phone  9937344446  
Fax    
Email  debasisdebata@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR DEBASIS DEBATA 
Designation  ASSISTANT PROFESSOR 
Affiliation  Kalinga Institute of Medical Sciences 
Address  department of Anaesthesiology 3RD FLOOR KIMS AND PBMH PATIA, BHUBANESHWAR

Khordha
ORISSA
751024
India 
Phone  9937344446  
Fax    
Email  debasisdebata@gmail.com  
 
Source of Monetary or Material Support  
B. KRISHNA PREETHI 
 
Primary Sponsor  
Name  B KRISHNA PREETHI 
Address  DEPT OF ANAESTHESIA 3RD FLOOR KIMS AND PBMH PATIA,BHUBANESHWAR. 
Type of Sponsor  Other [self] 
 
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 B KRISHNA PREETHI  Pradyumna bal memorial hospital.  Department of Anaesthesiology 3rd floor, KIMS, KIIT road, patia Bhubaneshwar
Khordha
ORISSA 
9618846462

doctorkrishnapreethi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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  ROCURONIUM  AFTER PRE MEDICATING THE PATIENT,0.05mg/kg OF ROCURONIUM WILL BE GIVEN 90SECONDS PRIOR TO SUCCINYLCHOLINE. 
Comparator Agent  VECURONIUM  AFTER PRE MEDICATING THE PATIENT,0.01mg/kg OF VECURONIUM WILL BE GIVEN 90SECONDS PRIOR TO SUCCINYLCHOLINE. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA:
Adult patients of either sex between 18-60yrs.
Patients of American society of anaesthesiologists(ASA) grade I and II physical status.
Patient posted for elective surgeries under general anaesthesia of duration atleast 30min. 
 
ExclusionCriteria 
Details  1.BMI > 30
2.History of allergy to any particular drug used in the study
3.History of egg allergy
4.History of substance abuse
5.Pregnancy
6.Post burn, post trauma, and other hyperkalemic states  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To reduce the undesirable side effects of succinylcholine like fasciculations and post operative myalgia.  INTRAOPERATIVELY 90 SECONDS AFTER GIVING SUCCINYLCHOLINE
AND POST OPERATIVELY DAY 1 2 AND 3 
 
Secondary Outcome  
Outcome  TimePoints 
TO PROVIDE BETTER INTUBATING CONDITIONS INTRA OPERATIVELY.  60-90seconds after completion of succinylcholine action. 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   01/11/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION:

Ideal muscle relaxant for endotracheal intubation should have specificity, rapid onset of action,profound muscle relaxation,free from haemodynamic changes and rapid with complete recovery. 

Succinylcholine is the ideal drug for endotracheal intubation after induction of anaesthesia. It has rapid onset of action and produces ideal intubating conditions. But it has undesirable side effects like fasciculations ,post operative myalgia, rise in intra-occular pressure, rise in serum potassium and serum creatinine phosphokinase levels and myoglobinuria. Many methods were tried earlier to decrease the side effects of succinylcholine,  out of which pre treatment with non-depolarising muscle relaxant is one.

In the present study , Rocuronium and Vecuronium will be tried to evaluate their efficacy as Pre-treatment before administration of succinylcholine.

AIM AND OBJECTIVES:

AIM:The aim of the study is to compare pre-treatment of Rocuronium and Vecuronium on post Succinylcholine  complications  like fasciculations and post operative myalgia.

PRIMARY OBJECTIVE:

       To reduce undesirable side effects of Succinylcholine like fasciculations and post operative myalgia.

SECONDARY OBJECTIVE:

         To provide better intubating conditions.

 

METHODOLOGY AND MATERIAL:

Source of data: Study will be conducted in Kalinga institute of medical sciences,PBMH, Bhubaneswar, Odisa. 

Study design: Randomized double blind study.

Sample size :  Assuming with 80% power and 5% level of significance sample size is calcuated  as140.

Duration of study: 2 years ( september2019 to september 2021)

INCLUSION CRITERIA:

1. Adult patients of either sex between 18-60yrs.

2. Patients of American society of Anaesthesiologists (ASA) grade I and II physical status.

3. Elective surgeries and the  duration of surgery is minimum of 30min.

EXCLUSION CRITERIA:

1. BMI > 30

2. History of allergy to any particular drug used in the study

3. History of  egg allergy

4. History of substance abuse

5. Pregnancy

6. Post burn, post trauma, and other hyperkalemic states 

RANDOMIZATION AND ALLOCATION:

Randomization will be done by computer generated randomization list. Then the patients will be allocated to one of the two groups by the opaque sealed envelope technique and will receive either of the two drugs.

A double blind technique will be followed, where an anaesthesiologist who is not part of the study will prepare the drug according to the allocated group. The Rocuronium 0.06mg/kg or Vecuronium 0.01mg/kg will be diluted to 2 ml with normal saline.  The drug will then be handed over to the investigator who will administer the drugs.

ANAESTHETIC TECHNIQUE :

Standard anaesthetic techniques will be followed in all patients. All patients are pre medicated with   inj.Glycopyrrolate 0.2mg IV, inj.Midazolam1mg IV, inj.Nalbuphine 0.1mg/kg IV. The given drug will be injected to the patient .After  90secs  inj. Propofol 2mg/kg IV and inj.Succinylcholine  1.5mg/kg IV will be injected intravenously. Presence of post succinylcholine fasciculations intraoperatively, intubation conditions,post operative  myalgia on day 1,day 2 and day 3 will noted . Severity of fasciculation will be assessed on a four point scale (Foster 1960)2

No Fasciculations - Nil

Very fine only at finger tips and/or facial muscles - Mild

Minimal fasciculations on trunk and extremities - Moderate

Vigorous fasciculations on trunk and extremities - Severe

Intubation condition will be assessed (Lund 1970)3

     SCORE

JAW RELAXATION

VOCAL CORD POSITION

RESPONSE TO INTUBATION

            0

Poor

Closed

Severe coughing

            1

Minimum

Closing

Mild coughing

            2

Moderate

Moving

Slight diaphragmatic movements

            3

Good

Open

None

Intubating Condition Total Score:

² Excellent-- 8-9

² Good------- 6-7

² Fair --------3-5

² Poor-------- 0-2

Intra-operatively anaesthesia was maintained with oxygen, nitrous oxide,  Isoflurane  and intermittent doses of Vecuronium. After completion of operative procedure, muscle relaxant will be reversed  with Inj. Glycopyrlolate 10 mcg/kg, Inj. Neostigmine 50 mcg/kg. Patient will be extubated after complete recovery from effect of muscle relaxants, and shifted to recovery room.

 

 

Myalgia  will be assessed on a four point scale (White 1962)4 on day1,day2,day3 post operative days.

1. NIL   No muscle pain.

2. MILD Musle pain or stiffness with no limitation of activity.

3. MODERATE Muscle pain and/or stiffness all over body, but no limitation of  activity.

4. SEVERE Muscle pain and stiffness with limitation of activity requiring treatment

DISCUSSION: All observations will be discussed with reference to currently available literature.

CONCLUSION : After reviewing the literature pertaining to the study, conclusion will be discussed in the final dissertation.

 
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