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CTRI Number  CTRI/2013/02/003438 [Registered on: 28/02/2013] Trial Registered Retrospectively
Last Modified On: 09/01/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Intranasal Dexmedetomidine or Oral Midazolam Premedication on the Minimum Alveolar Concentration of Sevoflurane for the Insertion of Laryngeal Mask Airway in children.  
Scientific Title of Study   The Effect of Intranasal Dexmedetomidine or Oral Midazolam Premedication on the Minimum Alveolar Concentration of Sevoflurane for the Insertion of Laryngeal Mask Airway in children. A comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
8460/PG-2Trg/2010/9 version 2.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Babita Ghai 
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Department of Anaesthesia and Intensive Care,Post Graduate Institute of Medical Education and Research, Sector-12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9914209533  
Fax  0172-2744401  
Email  ghaibabita@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Salvia Jyothi Rani 
Designation  Post Graduate Student 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Department of Anaesthesia and Intensive Care,Post Graduate Institute of Medical Education and Research, Sector-12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9855558494  
Fax  0172-2744401  
Email  rani.jyothi5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Babita Ghai 
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Department of Anaesthesia and Intensive Care,Post Graduate Institute of Medical Education and Research, Sector-12 Chandigarh

CHANDIGARH
160012
India 
Phone  9914209533  
Fax  0172-2744401  
Email  ghaibabita@hotmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Chandigarh 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Sector-12,Chandigarh, India-160012  
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 Babita Ghai  PGIMER, Chandigarh  Operation theater, Advanced pediatric center, 6th Floor, PGIMER, Sector 12
Chandigarh
CHANDIGARH 		 9914209533
0172-2744401
ghaibabita@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Review Committee, Postgraduate Institute of Medical Education And Research, Sector 12, Chandigarh-160012  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Any short elective surgical procedure under general anaesthesia which can be performed with LMA insertion ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group M received 0.5 mg/Kg oral midazolam and intranasal saline, group D received 2µg/Kg intranasal dexmedetomidine along with oral honey 20-30min before procedure.   EC 50 for LMA insertion was determined by using Dixon and Massey up and down method after the premedications mentioned above 
Comparator Agent  Group P received oral honey and intranasal saline (placebo group)   EC 50 for LMA insertion was determined by using Dixon and Massey up and down method in placebo group 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 patients of either gender of the age 1- 6 years undergoing any short elective surgical procedure under general anaesthesia which can be performed with LMA insertion  
 
ExclusionCriteria 
Details  airway malformations, clinical evidence of patients with difficult airway, asthma or any sign of upper respiratory tract infection, G6PD deficiency, organ dysfunction , allergy or hypersensitive reaction to dexmedetomidine , known cardiac arrhythmia or congenital heart disease, mentally disabled , known case of autism or developmental pervasive disorder or failure to insert LMA.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine and compare the EC50 of sevoflurane for LMA insertion in children in all the three groups  At or one minute after LMA insertion 
 
Secondary Outcome  
Outcome  TimePoints 
Ramsay Sedation Score, parental separation score, induction score success rate, and the incidence of adverse events  Ramsay sedation score at baseline, 15 and 30 minutes after premedication, parental separation score at taking the child in the OT and induction score at placing the face mask, adverse events at or one minute after LMA insretion 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   23/01/2012 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study was planned to evaluate and compare the effect of   intranasal dexmedetomidine or oral midazolam on the EC50 requirement of sevoflurane for LMA insertion in children compared to placebo.
 56 ASA 1 children (1-6yrs) scheduled for general anaesthesia with LMA were randomly allocated to three groups: group M received 0.5 mg/Kg oral midazolam and intranasal saline, group D received 2µg/Kg  intranasal dexmedetomidine along with oral honey, and  group P received oral honey and intranasal saline 30min before procedure. Anesthesia was induced with sevoflurane.A predetermined target end-tidal sevoflurae  concentration (starting at 2%) was maintained for 10 min using Dixon’s up-down method and the laryngeal mask airway was inserted without neuromuscular blockade. The target end-tidal concentration in the next patient was increased or decreased by 0.2% depending upon the response of the previous patient. Insertion of the laryngeal mask airway without coughing, clenching, biting, movement or any adverse airway event during or within 1 min after insertion was considered to be successful.in case of success the ET sevoflurane concentartion was decreased by 0.2% otherwise it was increased by 0.2%. All responses to an LMA insertion were assessed with the LMA insertion score.  
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