Comparison of Ketamine-propofol Combinations

Postoperative Pain Clinical Trial

Official title:

Effect of Ketamine-propofol Mixture on Postoperative Pain and Sedation-agitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848963
• Other study ID #: Ketamine-Propofol
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2016
• Last updated: April 19, 2017
• Start date: July 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2016
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Pain, Postoperative
• Postoperative Pain
• Psychomotor Agitation

Intervention

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

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana	Sariçam

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAED(Paediatric Anaesthesia Emergence Delirium) Scores Evaluation	All patients will be evaluate with PAED scores at PACU during first 1 hour	During 1 hour at post operative period
Secondary	Anaesthesia depth assessed using the Bispectral Index (BIS)	All Patients will monitored with BIS monitoring during operation.	During peroperative period.
Secondary	Extubation time	At the end of the surgery, time from injection of reversal to extubation	time from injection of reversal to extubation, through patient extubated
Secondary	FLACC(Face, leg movement, activity, craying, consolability)	All patients will be evaluate with FLACC scores at PACU during first 1 hour	During 1 hour at post operative period