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CTRI Number  CTRI/2017/09/009750 [Registered on: 13/09/2017] Trial Registered Retrospectively
Last Modified On: 28/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dexmedetomidine versus fentanyl for insertion of ProSeal LMA. 
Scientific Title of Study   “A comparative study between the efficacy of a combination of dexmedetomidine with propofol versus fentanyl with propofol for insertion of ProSeal laryngeal mask airway.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aaditya Anil Prabhudesai 
Designation  Post Graduate Trainee 
Affiliation  Medica Superspecialty Hospital 
Address  Department of Anaesthesiology and Pain Medicine Medica Superspecialty Hospital, 127, Mukundapur, E M Bypass, Kolkata

Kolkata
WEST BENGAL
700099
India 
Phone  9833138991  
Fax    
Email  p.aaditya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jaya Choudhary 
Designation  Consultant, Co-Guide 
Affiliation  Medica Superspecialty Hospital 
Address  Department of Anaesthesiology and Pain Medicine Medica Superspecialty Hospital, 127, Mukundapur, E M Bypass, Kolkata

Kolkata
WEST BENGAL
700099
India 
Phone  9833138991  
Fax    
Email  jaya20403@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Aaditya Anil Prabhudesai 
Designation  Post Graduate Trainee 
Affiliation  Medica Superspecialty Hospital 
Address  Department of Anaesthesiology and Pain Medicine Medica Superspecialty Hospital, 127, Mukundapur, E M Bypass, Kolkata

Kolkata
WEST BENGAL
700099
India 
Phone  9833138991  
Fax    
Email  p.aaditya@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Medica Superspecialty Hospital 
Address  127, Mukundapur, E. M. Bypass, Kolkata - 700 099. 
Type of Sponsor  Private hospital/clinic 
 
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 
Aaditya Anil Prabhudesai  Medica Superspecialty Hospital  Department of Anaesthesia And Pain Medicine/ 2nd Floor/ OT Complex
Kolkata
WEST BENGAL 
9833138991

p.aaditya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinical Research Ethics Committee, Medica Superspecialty Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Undergoing GA as ASA 1 and 2 category 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine  Dexmedetomidine; in a dose of 1 mcg/Kg was administered intravenously over 10 minutes prior to induction of anesthesia using propofol in a dose of 2.5 mg/kg 
Comparator Agent  Fentanyl  Fentanyl; in a dose of 1 mcg/Kg was administered intravenously over 10 minutes prior to induction of anesthesia with propofol in a dose of 2.5 mg/kg. 
Intervention  ProSeal LMA insertion  Comparison of Laryngear mask airway (LMA) insertion condition using LMA insertion score in the two study groups consisting of patients undergoing elective surgical procedures of upto maximum 120 minutes duration; under general anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 patients posted for Elective surgical procedures under general anaesthesia. 
 
ExclusionCriteria 
Details  1. Anticipated difficult airway.
2. Morbid obesity (BMI > 35).
3. Risk of gastric aspiration.
4. Patients undergoing oro – naso – pharyngeal surgeries
5. Pregnancy.
6. Those with respiratory diseases and smokers.
7. ASA grade III and IV patients.
8. Patients with bradycardia (Heart Rate less than 60beats/min) and on treatment with beta blocking agents.
9. Known sensitivity or allergy to propofol and/or dexmedetomidine and/or fentanyl.
10. Patients refusing the consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of the two adjuvants, dexmedetomidine and fentanyl in combination with propofol during ProSeal LMA insertion, in selected adult patients undergoing elective surgical procedures under general anaesthesia .  The ease of insertion of ProSeal LMA is evaluated using LMA insertion Score after 90 seconds of induction with propofol.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of the two drugs on haemodynamic and respiratory parameters in such patients.  The parameters are recorded before administration of study drug (Baseline), After administration of study drug (Pre-induction), and then after 1 minute, 3 minutes, 5 minutes, 10 minutes, 15 minutes after induction of anaesthesia with propofol. 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2017 
Date of Study Completion (India) 22/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Choudhary J, Prabhudesai A A, Datta C. Dexmedetomidine with propofol versus fentanyl with propofol for insertion of proseal laryngeal mask airway: a randomised double blinded clinical trial. J Anaesthesiol Clin Pharmacol 2019;35:368-372.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Supraglottic airways have become a standard device for airway management filling a gap between the face mask and the tracheal tube. It allows spontaneous ventilation as well as positive pressure ventilation. A Laryngeal Mask Airway (LMA) is one of such devices which can be safely used in general anaesthesia allowing spontaneous ventilation in place of facemask without a leak. LMA insertion also has an advantage of being less stimulating to the airways than the tracheal intubation. Therefore, lesser hemodynamic changes occur in response to LMA insertion as compared to those found during tracheal intubation. ProSeal LMA is a modification of classic LMA which provides a better seal and facilitates passage of oro-gastric tube for gastric suction.

 

Smooth insertion of LMA needs sufficient depth of anesthesia to suppress the airway reflexes and relax the jaw muscles. Inadequate depth of anesthesia may provoke coughing, gagging, laryngospasm and may lead to adverse hemodynamic changes. Therefore, optimal conditions for LMA insertion necessitate generous use of anesthetic agents.

 

Inhalational and Intravenous agents; both have been used for providing the satisfactory conditions for insertion of LMA. The intravenous (IV) anaesthetic agents are preferred over inhalational agents for insertion of LMA. Among the intravenous agents, propofol is the induction agent of choice, because of its potential suppressor effects on upper airway reflexes. Propofol when used alone often fails to provide satisfactory condition for insertion of LMA. This may lead to coughing, gagging, and even laryngospasm. In addition the higher doses of propofol required to produce adequate condition for insertion, may lead to undesirable cardiorespiratory depression. ProSeal LMA requires greater degree of anaesthetic depth for insertion as compared to classic LMA. The effective concentration of propofol (EC50 Prof LMA) required for ProSeal LMA insertion is 38% greater as compared to Classic LMA. To reduce the dose of propofol and maintain satisfactory insertion conditions various adjuvants have been combined with it in routine anaesthesia practice.

 

The most commonly used adjuvant for this purpose are; muscle relaxants, benzodiazepines, opioids, ketamine and α2 receptor agonists.The adjuvants reduce the EC50 of propofol for LMA insertion; thus decreasing the absolute dose of propofol and reducing the associated side effects. Amongst the adjuvants, fentanyl is commonly combined with propofol. Fentanyl is a short acting opioid agonist commonly used in combination with propofol. It depresses the airway reflex responses in a dose related manner and potentiates the effect of propofol.

 

Dexmedetomidine is a highly selective α2 receptor agonist. It produces sedative, anxiolytic and analgesic effects without causing clinically significant respiratory depression. It reduces the dose of propofol required to attain adequate depth of anaesthesia. It has also shown to diminish airway and circulatory responses during intubation and extubation.

On the basis of above observations we propose this study to compare the efficacy  of a combination of propofol and dexmedetomidine with that of propofol and fentanyl for successful ProSeal LMA insertion during general anesthesia.

 
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