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CTRI Number  CTRI/2019/01/017048 [Registered on: 11/01/2019] Trial Registered Prospectively
Last Modified On: 07/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of clonidine and magnesium sulphate in patients of ear nose and throatsurgeries. 
Scientific Title of Study   Comparison of intravenous magnesium sulphate and clonidine in attenuating the hemodynamic response, anesthetic consumption and postoperative recovery in patients undergoing elective ENT surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AMAN CHOUDHARY 
Designation  RESIDENT 
Affiliation  DR S.N. MEDICAL COLLEGE,JODHPUR 
Address  Department of otorhinolaryngology Operation theater no. 4 MDM Hospital jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9413904622  
Fax    
Email  dr.amanchoudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  AMAN CHOUDHARY 
Designation  RESIDENT 
Affiliation  DR S.N. MEDICAL COLLEGE,JODHPUR 
Address  Department of anaesthesiology MDM Hospital jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9413904622  
Fax    
Email  dr.amanchoudhary@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shobha Ujwal 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Department of anaesthesiology MDM HOSPITAL JODHPUR
Dr. S.N. medical collage, Jodhpur
Jodhpur
RAJASTHAN
342011
India 
Phone  9461028789  
Fax    
Email  drshobhaujwal@gmail.com  
 
Source of Monetary or Material Support  
MDM hospital,dr sn medical college,jodhpur  
 
Primary Sponsor  
Name  MDM hospital 
Address  Dr S N Medical College Jodhpur  
Type of Sponsor  Government 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 Shobha Ujwal  MDM hospital  Department of otorhinolaryngology and head &neck surgery OT NO.4
Jodhpur
RAJASTHAN 		 9461028789

drshobhaujwal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr. sampurnanand medical college jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H679||Otitis media in diseases classified elsewhere, unspecified ear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C  Group C (Clonidine): inj. clonidine 2μg/kg intravenously over a period of 15 minutes before induction and 0.5μg/kg/hour by continuous infusion intraoperatively & stopped at the end of the surgical procedure. 
Intervention  Group M  Group M (Magnesium Sulphate): inj. MgSO4 20mg/kg intravenously over a period of 15 minutes before induction and 5mg/kg/hour by continuous infusion intraoperatively & will be stopped at the end of the surgical procedure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)ASA group 1&2.
2)patients posted for eiective ENT surgeries who require GA and airway maintenance with ET intubation.
3)prior informed and written consent given by the patients.
4)age group between 18 to 60 years of either sex 
 
ExclusionCriteria 
Details  1)patients not willing to be part of this study.
2)patients who are having known allergy to the study drugs.
3)SBP<100mmHg and HR<60/min.
4)pt. with history of mysthenia gravis, muscular dystrophy or any other neuromuscular disease.
5)pts. with history of epilepsy/seizure disorder.
6)pts. who are taking antihypertensive medications.
7)pregnant patients. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to study and compare the effect of intravenous magnesium sulphate 20 mg per kg bolus followed by 10mg/kg/hr infusion and intravenous clonidine 2 microgram /kg bolus folloed by 0.5 microgram /kg/hrinfusion in attenuating the hemodynamic respnse to -1 laryngoscopy and endotracheal intubation ,extubation and recovery
 		 till recovery of patients 
 
Secondary Outcome  
Outcome  TimePoints 
anaesthetic consumption during surgery   till recovery of patients 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/01/2019 
Date of Study Completion (India) 30/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/11/2019 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Non yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 The present prospective ,randomized,double blind study over 68 adult patients undergoing elective ENT surgeries who require GA ,age between 18 -60 years of either sex.randomized in two groups.Primary aim is to study and compare the effect of IV Magnesium sulphate 20 mg/kg bolus followed by 10mg/kg/hr infusion and IV clonidine 2 ug/kg bolus followed by 0.5ug/kg/hr infusion in attenuating the haemodynamic ressponse to a) laryngoscopy and endotracheal intubation ,extubation and recovery. b) anaesthetic consumption during surgery. 
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