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Completed

NCT Number: NCT02848963

Comparison of Ketamine-propofol Combinations

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.

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Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cukurova University

Adana, Sarıçam, 01380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine-propofol mixture

Drug

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

Other names: ketofol

Primary outcomes

  1. 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

Secondary outcomes

  1. Anaesthesia depth assessed using the Bispectral Index (BIS)

    Time frame: During peroperative period.

    All Patients will monitored with BIS monitoring during operation.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 29, 2016
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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