FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/05/033541 [Registered on: 11/05/2021] Trial Registered Prospectively
Last Modified On: 10/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Dexmedetomidine versus Nitroglycerine infusion for hypotensive anaesthesia in FESS 
Scientific Title of Study   Comparison of Dexmedetomidine infusion with Nitroglycerine infusion for Hypotensive Anaesthesia in Functional Endoscopic Sinus Surgery- A Prospective Randomized Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Smitul Dave 
Designation  Assistant Professor 
Affiliation  Sri Lakshmi Narayana Institute of Medical Sciences 
Address  Department of Anaesthesiology, Sri Lakshmi Narayana Institute of Medical Sciences Osudu, Agaram village, Villianur Commune, Kudapakkam post, Puducherry

Pondicherry
PONDICHERRY
605502
India 
Phone  9408115792  
Fax    
Email  smitul1511@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  R Aishwarya 
Designation  Assistant Professor 
Affiliation  Sri Lakshmi Narayana Institute of Medical Sciences 
Address  Department of Anaesthesiology, Sri Lakshmi Narayana Institute of Medical Sciences Osudu, Agaram village, Villianur Commune, Kudapakkam post, Puducherry

Pondicherry
PONDICHERRY
605502
India 
Phone  9953413562  
Fax    
Email  ashirocks1989@gmail.com  
 
Details of Contact Person
Public Query  
Name  R Aishwarya 
Designation  Assistant Professor 
Affiliation  Sri Lakshmi Narayana Institute of Medical Sciences 
Address  Department of Anaesthesiology, Sri Lakshmi Narayana Institute of Medical Sciences Osudu, Agaram village, Villianur Commune, Kudapakkam post, Puducherry

Pondicherry
PONDICHERRY
605502
India 
Phone  9953413562  
Fax    
Email  ashirocks1989@gmail.com  
 
Source of Monetary or Material Support  
SRI LAKSHMI NARAYANA INSTITUTE OF MEDICAL SCIENCES, OSUDU, AGARAM VILLAGE, VILLIANUR COMMMUNE KUDAPAKKAM POST, PUDUCHERRY: 605502  
 
Primary Sponsor  
Name  DR SMITUL DAVE 
Address  ASSISTANT PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, SRI LAKSHMI NARAYANA INSTITUTE OF MEDICAL SCIENCES,OSUDU, AGARAM VILLAGE, VILLIANUR COMMMUNE KUDAPAKKAM POST, PUDUCHERRY: 605502 
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 
Smitul Dave  SRI LAKSHMI NARAYANA INSTITUTE OF MEDICAL SCIENCES  Dept of Anaesthesiology, Osudu, Agaram Village, Villianur Commune, Kudupakkam Post, Puducherry - 605 502, India.
Pondicherry
PONDICHERRY 		 9408115792

smitul1511@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(HUMAN STUDIES)  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infusion of pharmacological drug Dexmedetomidine  The patients will be given general anaesthesia using Intravenous fenatnyl, thiopentone and succinylcholine and intubated with endotracheal tube. After induction, infusion of Dexmedetomidine will be used to decrease the blood pressure during FESS surgery. Patients will receive Inj Dexmedetomidine 1 microgram/kg iv as a bolus dose over 10 minutes then followed by infusion at the rate of 0.3 - 0.5 microgram/kg/hour. The infusion will be started after intubation and titrated to achieve a MAP of 20% less than baseline. It will be continued till 10 minutes before expected end of surgical procedure. .  
Comparator Agent  Infusion of pharmacological drug Nitroglycerine  The patients will be given general anaesthesia using Intravenous fenatnyl, thiopentone and succinylcholine and intubated with endotracheal tube. After induction, infusion of Nitroglycerine will be used to decrease the blood pressure during FESS surgery. Patients will receive Inj Nitroglycerine as a continuous infusion in dose of 0.5 – 5microgram/kg/hour . The infusion will be started after intubation and titrated to achieve a MAP of 20% less than baseline. It will be continued till 10 minutes before expected end of surgical procedure. .  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I and II
undergoing FESS 
 
ExclusionCriteria 
Details  Patients with known allergy to drugs to be used, Pregnant and lactating women, History of chronic hypertension/ Sinus bradycardia, Patient refusal
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
quality of surgical field  2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Recovery profile
2. Post op analgesia
 		 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   N/A 
Date of First Enrollment (India)   17/05/2021 
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashirocks1989@gmail.com].

  6. For how long will this data be available start date provided 03-05-2022 and end date provided 03-05-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Total 60 adult patients of either sex of ASA physical status I / II will be included in the study. After thorough preoperative assessment of all patients, informed consent will be  taken from each patient. All patients will be  premedicated with inj. Fentanyl 2 microgram/kg, inj. Glycopyrolate 0.004 mg/kg, inj. Ondansetron 4mg. Intravenously. All patients will be induced with inj. Thiopentone sodium 6 mg/kg and inj. Succinylcholine 1.5 mg/kg. Oral intubation with proper size tube and packing will be done. Anaesthesia will be maintained with oxygen and nitrous oxide mixture( 50 : 50) + Sevoflurane ( 2% dial concentration) + inj. Atracurium. All patients will be  placed in Reverse Trendenburg position( 15 degree head up) after induction. Group D : Patients will receive inj. Dexmedetomidine 1 microgram/kg iv as a bolus dose over 10 minutes then followed by infusion at the rate of 0.3 - 0.5 microgram/kg/hour. Group N : Patients will receive inj. Nitroglycerine as a continuous infusion in dose of 0.5 – 5microgram/kg/hour. All patients will be  observed for Non Invasive Blood pressure, Heart rate, MAP and oxygen saturation at frequent intervals till the end of surgery. Surgical field quality will be  assessed by predefined category scale adopted from FROMM AND BOEZAART SCALE ( AVERAGE CATEGORY SCALE) .Recovery profile using Ramsay sedation score and Post op analgesia using VAS will be assessed hourly upto 6 hours. The collected data will be subjected to statistically analysis.

 
Close