Comparison of Ketamine-propofol Combinations

NCT ID: NCT02848963

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Agitation Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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ketamine-propofol mixture 5/1

Ketamine-propofol mixture will be compare for every groups.

Group Type ACTIVE_COMPARATOR

Ketamine-propofol mixture

Intervention Type DRUG

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

ketamine-propofol mixture 10/1

Ketamine-propofol mixture will be compare for every groups.

Group Type ACTIVE_COMPARATOR

Ketamine-propofol mixture

Intervention Type DRUG

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

Ketamine-propofol mixture 6,7/1

Ketamine-propofol mixture will be compare for every groups

Group Type ACTIVE_COMPARATOR

Ketamine-propofol mixture

Intervention Type DRUG

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

Interventions

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Ketamine-propofol mixture

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

Intervention Type DRUG

Other Intervention Names

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ketofol

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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ebru biricik

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Özcengiz, Professor

Role: STUDY_DIRECTOR

Cukurova University

Locations

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Cukurova University

Adana, Sarıçam, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 29249041 (View on PubMed)

Other Identifiers

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Ketamine-Propofol

Identifier Type: -

Identifier Source: org_study_id

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