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
|
|
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
|
|
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
|
|
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. |