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Clinical Trials/CTRI/2014/08/004905
CTRI/2014/08/004905CompletedNot Applicable

Comparative Evaluation Of Propofol-Ketamine And Propofol-Fentanyl For Laryngeal Mask Airway Insertion

Institute1 site in 1 country120 target enrollmentStarted: January 1, 2008Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Differences in insertion conditions for LMA insertion as assessed by a 6 variable, 3 point LMA insertion score

Study Overview

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 inclusionand exclusion criteria, were randomly allocated into two groups,propofol-ketamine (PK) and propofol-fentanyl (PF), each group consisting of 60patients, by sealed envelope technique. The study was designed to compare thehemodynamic responses to induction & insertion of LMA and the insertionconditions between propofol- ketamine and propofol- fentanyl combinations.

All patients received 0.3mg Glycopyrrolate, intramuscular,half an hour before the procedure.  Inthe operating room, after recording the baseline parameters- oxygen saturation(SpO2), Mean Blood Pressure (BP), Pulse Rate (PR) and End Tidalcarbon dioxide (EtCO2), 1µg/ kg Fentanyl to the PF group & 0.5mg/kg Ketamine to the PK group was given intravenously. Induction of anesthesiawas initiated with 1% Propofol @ 1mg/ kg/ min with a syringe pump, till thepatient tolerated a full jaw thrust, which was considered as the end point forLMA insertion. On reaching the end point, LMA insertion was attempted throughthe classical approach, as described by Brain. Proper position of LMA wasascertained by the ability to easily ventilate the lungs (assessed by chestmovement), without any significant resistance or leak and no significantresistance to expiration with rapid refilling of the reservoir bag. Acapnograph was also used to assess adequacy of ventilation.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Double Blind Double Dummy

Eligibility Criteria

Ages
20.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA 1 and 2 adults scheduled for elective surgical procedures under general anesthesia.

Exclusion Criteria

  • Contraindication for LMA usage
  • History of allergic reactions to any of the study drugs.

Outcomes

Primary Outcomes

Differences in insertion conditions for LMA insertion as assessed by a 6 variable, 3 point LMA insertion score

Time Frame: Induction of general anesthesia and LMA insertion

Secondary Outcomes

  • Hemodynamic responses (blood pressure and heart rate) to LMA insertion(Upto 10 minutes following insertion of LMA)

Investigators

Sponsor
Institute
Sponsor Class
Research institution and hospital

Study Sites (1)

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