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Comparison of Ketamine-propofol Combinations

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ClinicalTrials.gov Identifier: NCT02848963
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
ebru biricik, Cukurova University

Tracking Information
First Submitted Date  ICMJE July 21, 2016
First Posted Date  ICMJE July 29, 2016
Last Update Posted Date April 20, 2017
Study Start Date  ICMJE July 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ketamine-propofol Combinations
Official Title  ICMJE Effect of Ketamine-propofol Mixture on Postoperative Pain and Sedation-agitation
Brief Summary

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 %67 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 %80 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 %90 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.

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 %67 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 %80 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 %90 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Agitation
  • Postoperative Pain
Intervention  ICMJE Drug: Ketamine-propofol mixture
Ratio of Ketamine-propofol mixture will be compare for every groups.
Other Name: ketofol
Study Arms  ICMJE
  • Active Comparator: ketamine-propofol mixture 5/1
    Ketamine-propofol mixture will be compare for every groups.
    Intervention: Drug: Ketamine-propofol mixture
  • Active Comparator: ketamine-propofol mixture 10/1
    Ketamine-propofol mixture will be compare for every groups.
    Intervention: Drug: Ketamine-propofol mixture
  • Active Comparator: Ketamine-propofol mixture 6,7/1
    Ketamine-propofol mixture will be compare for every groups
    Intervention: Drug: Ketamine-propofol mixture
Publications * Biricik E, Karacaer F, Güleç E, Sürmelioğlu Ö, Ilgınel M, Özcengiz D. Comparison of TIVA with different combinations of ketamine-propofol mixtures in pediatric patients. J Anesth. 2018 Feb;32(1):104-111. doi: 10.1007/s00540-017-2438-8. Epub 2017 Dec 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2017)
75
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2016)
90
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848963
Other Study ID Numbers  ICMJE Ketamine-Propofol
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ebru biricik, Cukurova University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cukurova University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dilek Özcengiz, Professor Cukurova University
PRS Account Cukurova University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP