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
|
|
Primary Sponsor
|
Name |
Institute |
Address |
JIPMER
Dhanvantari Nagar
Puducherry 605006 |
Type of Sponsor |
Research institution and hospital |
|
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 |
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
|
|
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. |