NCT02848963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 20, 2017

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

July 21, 2016

Last Update Submit

April 19, 2017

Conditions

AgitationPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • PAED(Paediatric Anaesthesia Emergence Delirium) Scores Evaluation

    All patients will be evaluate with PAED scores at PACU during first 1 hour

    During 1 hour at post operative period

Secondary Outcomes (3)

  • Anaesthesia depth assessed using the Bispectral Index (BIS)

    During peroperative period.

  • Extubation time

    time from injection of reversal to extubation, through patient extubated

  • FLACC(Face, leg movement, activity, craying, consolability)

    During 1 hour at post operative period

Study Arms (3)

ketamine-propofol mixture 5/1

ACTIVE COMPARATOR

Ketamine-propofol mixture will be compare for every groups.

Drug: Ketamine-propofol mixture

ketamine-propofol mixture 10/1

ACTIVE COMPARATOR

Ketamine-propofol mixture will be compare for every groups.

Drug: Ketamine-propofol mixture

Ketamine-propofol mixture 6,7/1

ACTIVE COMPARATOR

Ketamine-propofol mixture will be compare for every groups

Drug: Ketamine-propofol mixture

Interventions

Ketamine-propofol mixtureDRUG

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

Also known as: ketofol
Ketamine-propofol mixture 6,7/1ketamine-propofol mixture 10/1ketamine-propofol mixture 5/1

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01380, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 29249041DERIVED

MeSH Terms

Conditions

Psychomotor AgitationPain, Postoperative

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorPostoperative ComplicationsPathologic ProcessesPain

Study Officials

  • Dilek Özcengiz, Professor

    Cukurova University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 29, 2016

Study Start

July 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

April 20, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)