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CTRI Number  CTRI/2013/08/003881 [Registered on: 06/08/2013] Trial Registered Prospectively
Last Modified On: 02/08/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, Fentanyl and Butorphanol in combination with another drug Propofol for general anaesthesia using a device called Laryngeal mask airway. 
Scientific Title of Study   Comparative evaluation of Fentanyl versus Butorphanol during induction with Propofol on LMA insertion conditions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjana Menon 
Designation  Post Graduate Student, Department of Anaesthesiology 
Affiliation  Government Medical College, Thiruvananthapuram 
Address  Department of Anaesthesiology, Government Medical College, Thiruvananthapuram, Kerala, India

Thiruvananthapuram
KERALA
695011
India 
Phone  9497641298  
Fax    
Email  dranjanamenon@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sobha S 
Designation  Additional Professor of Anaesthesiology, Department of Anaesthesiology  
Affiliation  Government Medical College, Thiruvananthapuram 
Address  Department of Anaesthesiology, Government Medical College, Thiruvananthapuram, Kerala, India

Thiruvananthapuram
KERALA
695011
India 
Phone  9497640396  
Fax    
Email  sobhathambu@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sobha S 
Designation  Additional Professor of Anaesthesiology, Department of Anaesthesiology  
Affiliation  Government Medical College, Thiruvananthapuram 
Address  Department of Anaesthesiology, Government Medical College, Thiruvananthapuram, Kerala, India

Thiruvananthapuram
KERALA
695011
India 
Phone  9497640396  
Fax    
Email  sobhathambu@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Anjana Menon  Department of Anaesthesiology, Government Medical College, Thiruvananthapuram  Department of Anaesthesiology, Government Medical College, Thiruvananthapuram, Kerala, India 695 011
Thiruvananthapuram
KERALA 		 9497641298

dranjanamenon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee, Government Medical College, Thiruvananthapuram.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Classical Laryngeal Mask Airway insertion condition on American Society of Anaesthesiologists Physical Status I and II patients who require requires general anaesthesia for short surgical procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator agent: Intravenous Fentanyl  Comparator agent: Fentanyl – 1 microgram/kilogram. dose - 1 microgram/kilogram, frequency - single dose, duration - once and route of administration - Intravenous. 
Intervention  Intervention agent: Intravenous Butorphanol - 20 microgram/kilogram single dose  Intervention agent: Butorphanol. dose - 20 microgram/kilogram, frequency - single dose, duration - once and route of administration - Intravenous. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Adult males or females of age group 18 to 55 years who comes under the American Society of Anaesthesiologists (ASA) Physical Status I and II for short surgical procedures who need LMA for maintaining general anaesthesia.
 
 
ExclusionCriteria 
Details  Patients of the American Society of Anaesthesiologists (ASA) Physical Status III and IV, those who suffer from pharyngeal pathology, low pulmonary compliance or history of allergy to Propofol, Butorphanol and Fentanyl. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Jaw relaxation according to Young’s criteria  60 seconds following the studied drug and Propofol is administered 
 
Secondary Outcome  
Outcome  TimePoints 
Overall LMA insertion condition according to modified Scheme of Lund and Stovener  60 seconds following the studied drug and Propofol is administered 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   09/08/2013 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized, double blind, parallel group, single-centre trail comparing the efficacy of intravenous Fentanyl 1 microgram/kilogram versus intravenous Butorphanol 20 microgram/kilogram as adjunct drugs during Propofol induction on LMA insertion conditions in 60 patients over a time period of 6 months which will be conducted in Department of Anaesthesiology, Government Medical College, Thiruvananthapuram, India. The primary outcome measure will be jaw relaxation according to Young’s criteria at 60 seconds after the adjunct drug and Propofol is administered. The secondary outcomes will be overall LMA insertion conditions according to modified Scheme of Lund and Stovener at 60 seconds after the adjunct drug and Propofol is administered.  
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