Comparison of Ketamine-propofol Combinations

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Turkey

Cukurova University

Adana, Sarıçam, Turkey, 01380

Sponsors and Collaborators

Cukurova University

Investigators

• Study Director: Dilek Özcengiz, Professor; Cukurova University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Biricik E, Karacaer F, Güleç E, Sürmelioğlu Ö, Ilgınel M, Özcengiz 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.

• Responsible Party: ebru biricik, Principal Investigator, Cukurova University
• ClinicalTrials.gov Identifier: NCT02848963
• Other Study ID Numbers: Ketamine-Propofol
• First Posted: July 29, 2016
• 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:

Psychomotor Agitation; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; 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