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CTRI Number  CTRI/2021/12/038529 [Registered on: 09/12/2021] Trial Registered Prospectively
Last Modified On: 09/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   General Anesthesia intubation response 
Scientific Title of Study   Effect of oral clonidine and oral tizanidine on the induction dose of propofol and intubation response in general anesthesia-comparative study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Elavanya 
Designation  Assistant professor 
Affiliation  srilakshmi narayana institute of medical sciences 
Address  Department of Anesthesiology,Srilakshmi narayana institute of medical sciences,osudu,villunur commune,kudapakkam post,puducherry

Pondicherry
PONDICHERRY
605502
India 
Phone  9629181969  
Fax    
Email  dr.lavanya08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Elavanya 
Designation  Assistant professor 
Affiliation  srilakshmi narayana institute of medical sciences 
Address  Department of Anesthesiology,Srilakshmi narayana institute of medical sciences,osudu,villunur commune,kudapakkam post,puducherry

Pondicherry
PONDICHERRY
605502
India 
Phone  9629181969  
Fax    
Email  dr.lavanya08@gmail.com  
 
Details of Contact Person
Public Query  
Name  Elavanya 
Designation  Assistant professor 
Affiliation  srilakshmi narayana institute of medical sciences 
Address  Department of Anesthesiology,Srilakshmi narayana institute of medical sciences,osudu,villunur commune,kudapakkam post,puducherry

Pondicherry
PONDICHERRY
605502
India 
Phone  9629181969  
Fax    
Email  dr.lavanya08@gmail.com  
 
Source of Monetary or Material Support  
srilakshmi narayanainstitute of medical sciences 
 
Primary Sponsor  
Name  self 
Address  Department of Anesthesia,srilakshi narayana institute of medical sciences,osudu,villunur commune,kudapakkampost,pondicherry-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 
elavanya  department of anesthesiology,general surgery operation theatre second floor.  osudu,villunur commune,agaqram village,kudapakkam post,puducherry
Pondicherry
PONDICHERRY 		 9629181969

dr.lavanya08@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 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  drug clonidine  100mcg of clonidine were adminstered 60 min before the induction of general anesthesia and will be monitoring the intubation 00,1,3,5 min response at the time of intubation 
Comparator Agent  drug tizanidine  4mg of tab tizanidine in other group will be administered 60 min before the estimated induction time and will be monitoring the intubation response at 00,and 1,3,5min from the time of intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  willing patients,ASA1 &2 ,ELECTIVE CASES 
 
ExclusionCriteria 
Details  ASA 3 OR MORE
PREGNANT AND LACTATING MOTHER
ANTICIPATED DIFFICULT AIRWAYUNCONTROLLED CHRONIC ILLNESS LIKE DIABETES MELLITUS,ASTHMA,SMOKERS,ON MONOAMINA OXIDASE INHIBITORS,PATIENTS WITH PREVIOUS RENAL AND HEPATIC DYSFUNCTION,HEAR DISEASES,VALVULAR HEART DISEASE,ELECTROPHYSICAL ABNORMALITIES,AND OTHER HEMODYNAMIC INSTABILITY. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
This study attempts to survey the effects of the oral premedication Tizanidine and clonidine on intraoperative hemodynamic responses during tracheal intubation  at intubation,1,3 abd 5 min after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
calculation the induction dose of propofol in general anesthesia.  30min 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   12/12/2021 
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="0"
Months="6"
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 [dr.lavanya08@gmail.com].

  6. For how long will this data be available start date provided 29-11-2021 and end date provided 29-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary   direct laryngoscopy and intubation may results in increase in blood pressure and heart rate which inturn leads to myocardial ischemia,cerebral hemorrhage and cardiac arrest in hemodynamicaly instable and susceptible patients.minimizing persistent and severe alterations in heart rate and blood pressure is critical.usual recommendations suggest maintaining heart rate and blood pressure at 20% of the basal value.alpha 2 receptor agonists decrease the catecholamine release thus can diminish the hyper dynamic status which renders the patients prone to ischemia.Hemodynamic stabilization,during and after the operations is most important mechanism by which the aplha2 receptor agonists reduce perioperative ischemia.thus we compared the drugs clonidine and tizanidine on the anesthetic requirements and the recpvery from general anesthesia. 
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