Comparison of Ketamine-propofol Combinations

Overview

ASA I-II 3-12 years old children participated to this study. All Participants will divide into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of ketamine-propofol mixture with of Mcfarlan dose regiment. In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol mixture with of Mcfarlan dose regiment. In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with of Mcfarlan dose regiment. After than surgical operation recovery time, PAED scores, FLACC scores, Staying time in PACU will be recorded. These data will be evaluated with statistically.

Full Title of Study: “Effect of Ketamine-propofol Mixture on Postoperative Pain and Sedation-agitation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2017

Detailed Description

ASA I-II, 3-12 years old children who will operate due to tonsillectomy and adenoidectomy. will be participated in to this study. All Participants will divide into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of ketamine-propofol mixture with of Mcfarlan dose regiment. In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol mixture with of Mcfarlan dose regiment. In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with of Mcfarlan dose regiment. McFarlan dose regiments include 15 mg/kg/h infusion during 15 minutes, 13 mg/kg/h infusion during second 15 minutes, 11 mg/kg/h infusion from 30 to 60 minutes, 10 mg/kg/h from 1 to 2 h. Anaesthesia dept will be detect with BIS monitoring during operation. After than surgical operation recovery time, PAED scores, FLACC scores, staying time in PACU and extubation time will be record. At the end of the study, these data will be evaluated with statistically.

Interventions

  • Drug: Ketamine-propofol mixture
    • Ratio of Ketamine-propofol mixture will be compare for every groups.

Arms, Groups and Cohorts

  • Active Comparator: ketamine-propofol mixture 5/1
    • Ketamine-propofol mixture will be compare for every groups.
  • Active Comparator: ketamine-propofol mixture 10/1
    • Ketamine-propofol mixture will be compare for every groups.
  • Active Comparator: Ketamine-propofol mixture 6,7/1
    • Ketamine-propofol mixture will be compare for every groups

Clinical Trial Outcome Measures

Primary Measures

  • PAED(Paediatric Anaesthesia Emergence Delirium) Scores Evaluation
    • Time Frame: During 1 hour at post operative period
    • All patients will be evaluate with PAED scores at PACU during first 1 hour

Secondary Measures

  • Anaesthesia depth assessed using the Bispectral Index (BIS)
    • Time Frame: During peroperative period.
    • All Patients will monitored with BIS monitoring during operation.
  • Extubation time
    • Time Frame: time from injection of reversal to extubation, through patient extubated
    • At the end of the surgery, time from injection of reversal to extubation
  • FLACC(Face, leg movement, activity, craying, consolability)
    • Time Frame: During 1 hour at post operative period
    • All patients will be evaluate with FLACC scores at PACU during first 1 hour

Participating in This Clinical Trial

Inclusion Criteria

  • ASA I-II children – Children who will be performed to adenoidectomy and tonsillectomy surgical operations Exclusion Criteria:

  • ASA III-IV children – Patients over the age of 13

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cukurova University
  • Provider of Information About this Clinical Study
    • Principal Investigator: ebru biricik, Principal Investigator – Cukurova University
  • Overall Official(s)
    • Dilek Özcengiz, Professor, Study Director, Cukurova University

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