Comparison of Ketamine-propofol Combinations

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

Tracking Information

• First Submitted Date: July 21, 2016
• First Posted Date: July 29, 2016
• Last Update Posted Date: April 20, 2017
• Study Start Date: July 2016
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Ketamine-propofol Combinations
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Prevention

Condition

• Agitation
• Postoperative Pain

Intervention

Drug: Ketamine-propofol mixture

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

Other Name: ketofol

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2017): 75
• Original Estimated Enrollment (submitted: July 26, 2016): 90
• Actual Study Completion Date: February 2017
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 3 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT02848963
• Other Study ID Numbers: Ketamine-Propofol
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ebru biricik, Cukurova University
• Original Responsible Party: Same as current
• Current Study Sponsor: Cukurova University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Dilek Özcengiz, Professor; Cukurova University

• PRS Account: Cukurova University
• Verification Date: October 2016