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Comparison of Ketamine-propofol Combinations

Primary Purpose

Agitation, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ketamine-propofol mixture
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

ketamine-propofol mixture 5/1

ketamine-propofol mixture 10/1

Ketamine-propofol mixture 6,7/1

Arm Description

Ketamine-propofol mixture will be compare for every groups.

Ketamine-propofol mixture will be compare for every groups.

Ketamine-propofol mixture will be compare for every groups

Outcomes

Primary Outcome Measures

PAED(Paediatric Anaesthesia Emergence Delirium) Scores Evaluation
All patients will be evaluate with PAED scores at PACU during first 1 hour

Secondary Outcome Measures

Anaesthesia depth assessed using the Bispectral Index (BIS)
All Patients will monitored with BIS monitoring during operation.
Extubation time
At the end of the surgery, time from injection of reversal to extubation
FLACC(Face, leg movement, activity, craying, consolability)
All patients will be evaluate with FLACC scores at PACU during first 1 hour

Full Information

First Posted
July 21, 2016
Last Updated
April 19, 2017
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT02848963
Brief Title
Comparison of Ketamine-propofol Combinations
Official Title
Effect of Ketamine-propofol Mixture on Postoperative Pain and Sedation-agitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketamine-propofol mixture 5/1
Arm Type
Active Comparator
Arm Description
Ketamine-propofol mixture will be compare for every groups.
Arm Title
ketamine-propofol mixture 10/1
Arm Type
Active Comparator
Arm Description
Ketamine-propofol mixture will be compare for every groups.
Arm Title
Ketamine-propofol mixture 6,7/1
Arm Type
Active Comparator
Arm Description
Ketamine-propofol mixture will be compare for every groups
Intervention Type
Drug
Intervention Name(s)
Ketamine-propofol mixture
Other Intervention Name(s)
ketofol
Intervention Description
Ratio of Ketamine-propofol mixture will be compare for every groups.
Primary Outcome Measure Information:
Title
PAED(Paediatric Anaesthesia Emergence Delirium) Scores Evaluation
Description
All patients will be evaluate with PAED scores at PACU during first 1 hour
Time Frame
During 1 hour at post operative period
Secondary Outcome Measure Information:
Title
Anaesthesia depth assessed using the Bispectral Index (BIS)
Description
All Patients will monitored with BIS monitoring during operation.
Time Frame
During peroperative period.
Title
Extubation time
Description
At the end of the surgery, time from injection of reversal to extubation
Time Frame
time from injection of reversal to extubation, through patient extubated
Title
FLACC(Face, leg movement, activity, craying, consolability)
Description
All patients will be evaluate with FLACC scores at PACU during first 1 hour
Time Frame
During 1 hour at post operative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Özcengiz, Professor
Organizational Affiliation
Cukurova University
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Sarıçam
ZIP/Postal Code
01380
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29249041
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.
Results Reference
derived

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Comparison of Ketamine-propofol Combinations

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