Comparison of Ketamine-propofol Combinations

Çukurova University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Agitation

Treatments: Drug: Ketamine-propofol mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT02848963

Ketamine-Propofol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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75 participants in 3 patient groups

ketamine-propofol mixture 5/1

Active Comparator group

Description:

Ketamine-propofol mixture will be compare for every groups.

Treatment:

Drug: Ketamine-propofol mixture

ketamine-propofol mixture 10/1

Active Comparator group

Description:

Ketamine-propofol mixture will be compare for every groups.

Treatment:

Drug: Ketamine-propofol mixture

Ketamine-propofol mixture 6,7/1

Active Comparator group

Description:

Ketamine-propofol mixture will be compare for every groups

Treatment:

Drug: Ketamine-propofol mixture