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Comparison of Ketamine-propofol Combinations

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ClinicalTrials.gov Identifier: NCT02848963
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
ebru biricik, Cukurova University

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.


Condition or disease Intervention/treatment Phase
Agitation Postoperative Pain Drug: Ketamine-propofol mixture Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Ketamine-propofol Mixture on Postoperative Pain and Sedation-agitation
Study Start Date : July 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: ketofol




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848963


Locations
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Turkey
Cukurova University
Adana, Sarıçam, Turkey, 01380
Sponsors and Collaborators
Cukurova University
Investigators
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Study Director: Dilek Özcengiz, Professor Cukurova University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ebru biricik, Principal Investigator, Cukurova University
ClinicalTrials.gov Identifier: NCT02848963     History of Changes
Other Study ID Numbers: Ketamine-Propofol
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psychomotor Agitation
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dyskinesias
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Ketamine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action