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CTRI Number  CTRI/2020/01/022888 [Registered on: 21/01/2020] Trial Registered Prospectively
Last Modified On: 15/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare two durgs intravenous dexmeditomidine and intravenous magnesium sulphate in improving surgical field visualisation in functional endoscopic sinus surgery 
Scientific Title of Study   Comparison of intravenous Magnesium Sulphate vs Dexmedetomidine in improving visualization of surgical field in functional endoscopic sinus surgery. A randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumitha N 
Designation  Junior Resident 
Affiliation  Pondicherry Institute Of Medical Sciences 
Address  Department of Anaesthesia,PIMS,kalapet,Ganapathichettykulam,Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9487830611  
Fax    
Email  sumithadr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sivakumar S 
Designation  Associate Professor 
Affiliation  Pondicherry Institute Of Medical Sciences 
Address  Department of Anaesthesia,PIMS,kalapet,Ganapathichettykulam,Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9944060676  
Fax    
Email  siva85dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sivakumar S 
Designation  Associate Professor 
Affiliation  Pondicherry Institute Of Medical Sciences 
Address  Department of Anaesthesia,PIMS,kalapet,Ganapathichettykulam,Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9944060676  
Fax    
Email  siva85dr@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute Of Medical Sciences, Kalapet, Ganapathychettykulam,puducherry-605014 
 
Primary Sponsor  
Name  Sumitha N 
Address  Pondicherry Institute Of Medical Sciences,Kalapet, Ganapathychettykulam, puducherry-605014  
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 
Sumitha N  Pondicherry Institute Of Medical Sciences  Pondicherry Institute Of Medical Sciences, kalapet,Ganapathichettykulam,Pondicherry 605014
Pondicherry
PONDICHERRY 
9487830611

sumithadr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute Ethics Committee,Regd. with CDSCO-Reg. no ECR/400/Inst/Py/2013  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  Group A- Magnesium Sulphate   Intravenous Magnesium Sulphate loading dose @ 40 mg/kg in 100ml NS over 10 minutes before induction. After induction, maintenance dose will be started on continuous infusion of MgSo4 @ 10 – 15 mg/kg/hr .After the procedure is over and when nasal packing (Gelfoam, Merocel) is started the infusions will be stopped. 
Comparator Agent  Group B - Dexmedetomidine   Patients in Group B will receive Dexmedetomidine 1µg/kg in 100ml NS over 10 minutes as loading dose .After induction, the patients in group B will be started on continuous infusion of Dexmedetomidine @ 0.2 - 0.5 µg/kg/hr till the end of surgery .  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Elective FESS
2.American society of anesthesiologist class I or
II
3.Body mass index 18 to 30 kg/m2
 
 
ExclusionCriteria 
Details  1. Patient having any arrhythmias-especially
bradyarrhythmias and conduction block
2. Chronic hypertension
3. Allergy to Dexmedetomidine or Magnesium
Sulfate
4. Patients with neuromuscular diseases
5. Psychiatric disorders
6. Cardiovascular diseases
7. Those receiving Calcium Channel Blockers
8. Long history of Diabetes Mellitus with autonomic dysfunction.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
bleeding score   6 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Surgeons satisfaction score  6 hours 
Ramsay Sedation Score  6 hours 
hemodynamic parameter  6 hours 
 
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 2/ Phase 3 
Date of First Enrollment (India)   22/01/2020 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   study will be published after cpompletion 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Functional endoscopic sinus surgery (FESS) is a revolution in the surgical procedures for chronic sinus and other paranasal sinus diseases, by making it the procedure of choice. It is minimally invasive, shortens procedure duration, minimizes surgical scar, reduces complication rate and reduces the discomfort of the patient.

However, there can be serious complications associated with FESS like orbital injuries, optic nerve injuries, CSF leak etc. due to close proximity of the blood vessels, nerves and the orbital and intracranial cavities, whose incidence can be increased with excessive bleeding during surgery

The major requirement for functional endoscopic sinus procedure is a relatively bloodless surgical field to provide better visualization and successful outcome of the procedure despite the high vascularity of the surgical area.This can be achieved by controlled hypotensive technique which is an accepted technique worldwide. Controlled hypotensive technique is by maintaining a mean arterial pressure of 60-70 mmHg which reduces the bleeding from the surgical site thereby resulting in less blood loss, better visualization leading to reduction in complications and surgeons satisfaction is also improved. 

The ideal agent used for controlled hypotension should have certain characteristics like ease of administration, shorter onset and offset time, negligible metabolism without any toxic metabolites and minimal effect on various organ systems.

Controlled hypotension involves reducing arterial blood pressure 30– 40% below its normal range or reducing MAP (mean arterial pressure) to 65 mm of Hg reversibly and maintaining it at that level throughout the surgery. 

Various methods have been used to achieve controlled hypotension like positioning, pharmacological methods and arteriotomy. Pharmacological drugs sodium nitroprusside, NTG, hydralazine, volatile anaesthetic, intravenous anaesthetics like propofol and betablockers have been used with various success rates.

Dexmedetomidine is a potent highly selective alpha 2 receptor agonist. It has the property of sedation, analgesia and anxiolytic. It causes sympatholysis by acting at central alpha 2a receptor and imidazoline type1 receptor and presynaptic blockade of the release of norepinephrine, thereby causing controlled hypotension. 

Magnesium Sulphate causes stabilization of the cell membrane and intracytoplasmic organelles by inhibiting the activation of NA-K ATPase and Ca- ATPase enzyme. It also limits Ca2+ outflow from sarcoplasmic reticulum by inhibiting L-type Ca channels in sarcoplasmic reticulum. In addition Mg2+ acts as a vasodilator by increasing the synthesis of prostacyclin, as well as by inhibiting ACE (angiotensin converting enzyme) activity. 

Since there are only very few studies on comparing these two drugs in producing controlled hypotension, our aim is to compare these two drugs in terms of satisfaction of surgeon, visibility of the field, blood loss, hemodynamic profile and to note any complication if any. 
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