Clinical trial NCT02848963: Comparison of Ketamine-propofol Combinations
Official title: Effect of Ketamine-propofol Mixture on Postoperative Pain and Sedation-agitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitation
Postoperative Pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: PAED(Paediatric Anaesthesia Emergence Delirium) Scores Evaluation
timeFrame: During 1 hour at post operative period
Secondary outcomes:
measure: Anaesthesia depth assessed using the Bispectral Index (BIS)
timeFrame: During peroperative period.
measure: Extubation time
timeFrame: time from injection of reversal to extubation, through patient extubated
measure: FLACC(Face, leg movement, activity, craying, consolability)
timeFrame: During 1 hour at post operative period
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sarıçam
Study officials:
affiliation: Cukurova University
name: Dilek Özcengiz, Professor
role: STUDY_DIRECTOR
References:
citation: Biricik E, Karacaer F, Gulec E, Surmelioglu O, Ilginel M, Ozcengiz 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.