Comparison of Ketamine-propofol Combinations

Effect of Ketamine-propofol Mixture on Postoperative Pain and Sedation-agitation

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Agitation
• Intervention / Treatment: Drug: Ketamine-propofol mixture

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
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Sarıçam
    • Adana, Sarıçam, Turkey, 01380
      • Çukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ketamine-propofol mixture 5/1; Ketamine-propofol mixture will be compare for every groups.	Drug: Ketamine-propofol mixture; Ratio of Ketamine-propofol mixture will be compare for every groups.; Other Names: ketofol
Active Comparator: ketamine-propofol mixture 10/1; Ketamine-propofol mixture will be compare for every groups.	Drug: Ketamine-propofol mixture; Ratio of Ketamine-propofol mixture will be compare for every groups.; Other Names: ketofol
Active Comparator: Ketamine-propofol mixture 6,7/1; Ketamine-propofol mixture will be compare for every groups	Drug: Ketamine-propofol mixture; Ratio of Ketamine-propofol mixture will be compare for every groups.; Other Names: ketofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anaesthesia depth assessed using the Bispectral Index (BIS)	All Patients will monitored with BIS monitoring during operation.	During peroperative period.
Extubation time	At the end of the surgery, time from injection of reversal to extubation	time from injection of reversal to extubation, through patient extubated
FLACC(Face, leg movement, activity, craying, consolability)	All patients will be evaluate with FLACC scores at PACU during first 1 hour	During 1 hour at post operative period

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Study Director: Dilek Özcengiz, Professor, Çukurova University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Pain, Postoperative; Psychomotor Agitation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Propofol
• Other Study ID Numbers: Ketamine-Propofol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No