Comparison of Ketamine-propofol Combinations

Phase 4

Completed

• Conditions: Agitation; Postoperative Pain
• Interventions: Drug: Ketamine-propofol mixture

• Registration Number: NCT02848963
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Status Verified: 2016-10
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ketamine-propofol mixture 10/1	Ketamine-propofol mixture	Ketamine-propofol mixture will be compare for every groups.
ketamine-propofol mixture 5/1	Ketamine-propofol mixture	Ketamine-propofol mixture will be compare for every groups.
Ketamine-propofol mixture 6,7/1	Ketamine-propofol mixture	Ketamine-propofol mixture will be compare for every groups

Primary Outcome Measures

Name	Time	Method
PAED(Paediatric Anaesthesia Emergence Delirium) Scores Evaluation	During 1 hour at post operative period	All patients will be evaluate with PAED scores at PACU during first 1 hour

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Sarıçam, Turkey