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
|
|
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
|
|
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. |