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CTRI Number  CTRI/2014/08/004905 [Registered on: 21/08/2014] Trial Registered Retrospectively
Last Modified On: 22/08/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of insertion conditions of a laryngeal mask airway under propofol-ketamine or propofol-fentanyl anesthesia  
Scientific Title of Study   Comparative Evaluation Of Propofol-Ketamine And Propofol-Fentanyl For Laryngeal Mask Airway Insertion  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satyen Parida 
Designation  Associate Professor 
Affiliation  Dept of Anesthesiology & Critical Care 
Address  Dept of Anesthesiology & Critical Care JIPMER Dhanvantari Nagar PUDUCHERRY 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9940973502  
Fax    
Email  jipmersatyen@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  R M Mohan Kumar 
Designation  Senior Resident 
Affiliation  JIPMER, Puducherry 
Address  Dept of Anesthesiology & Critical Care JIPMER Dhanvantari Nagar PUDUCHERRY 605006

Pondicherry
PONDICHERRY
605006
India 
Phone    
Fax    
Email  mohankumarrm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Satyen Parida 
Designation  Associate Professor 
Affiliation  Dept of Anesthesiology & Critical Care 
Address  Dept Anesthesiology & Critical Care JIPMER Dhanvantari Nagar Puducherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9940973502  
Fax    
Email  jipmersatyen@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Institute 
Address  JIPMER Dhanvantari Nagar Puducherry 605006 
Type of Sponsor  Research institution and hospital 
 
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 Satyen Parida  Dept of Anesthesiology & Critical Care  JIPMER Dhanvantari Nagar
Pondicherry
PONDICHERRY 
9940973502

jipmersatyen@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA 1 and 2 adults scheduled for elective surgical procedures under general anesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Propofol-fentanyl   Fentanyl 1 mcg/kg IV before induction and Propofol @ 1 mg/kg/min IV for induction of anesthesia until loss of consciousness 
Intervention  Propofol-ketamine   Ketamine 0.5 mg/kg IV before induction and Propofol @ 1 mg/kg/min IV for induction of anesthesia until loss of consciousness 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 adults scheduled for elective surgical procedures under general anesthesia  
 
ExclusionCriteria 
Details  1. Contraindication for LMA usage
2. History of allergic reactions to any of the study drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Differences in insertion conditions for LMA insertion as assessed by a 6 variable, 3 point LMA insertion score  Induction of general anesthesia and LMA insertion 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic responses (blood pressure and heart rate) to LMA insertion  Upto 10 minutes following insertion of LMA 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2008 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This was a double-blinded, randomized, controlled study, conducted in adult, ASA 1 and 2 patients, undergoing elective surgical procedures. 120 patients, satisfying the inclusion and exclusion criteria, were randomly allocated into two groups, propofol-ketamine (PK) and propofol-fentanyl (PF), each group consisting of 60 patients, by sealed envelope technique. The study was designed to compare the hemodynamic responses to induction & insertion of LMA and the insertion conditions between propofol- ketamine and propofol- fentanyl combinations.

            All patients received 0.3mg Glycopyrrolate, intramuscular, half an hour before the procedure.  In the operating room, after recording the baseline parameters- oxygen saturation (SpO2), Mean Blood Pressure (BP), Pulse Rate (PR) and End Tidal carbon dioxide (EtCO2), 1µg/ kg Fentanyl to the PF group & 0.5 mg/kg Ketamine to the PK group was given intravenously. Induction of anesthesia was initiated with 1% Propofol @ 1mg/ kg/ min with a syringe pump, till the patient tolerated a full jaw thrust, which was considered as the end point for LMA insertion. On reaching the end point, LMA insertion was attempted through the classical approach, as described by Brain. Proper position of LMA was ascertained by the ability to easily ventilate the lungs (assessed by chest movement), without any significant resistance or leak and no significant resistance to expiration with rapid refilling of the reservoir bag. A capnograph was also used to assess adequacy of ventilation.

 
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