Effect of Ketofol Versus Propofol as an Induction Agent on Ease of Laryngeal Mask Airway Insertion Conditions and Hemodynamic Stability in Pediatrics

An Observational Prospective Cohort Study

Bacha Aberra; Adugna Aregawi; Girmay Teklay; Hagos Tasew

Disclosures

BMC Anesthesiol. 2019;19(41) 

In This Article

Methods

Study Objective

The aim of this study was to compare the effect of the ketamine-propofol mixture (ketofol) and propofol on the insertion conditions of laryngeal mask airway and hemodynamic stability in pediatrics.

Study Design

An observational prospective cohort study was employed from Jan 25-March, 25, 2017 after ethical approval (No-11/2009, Dec 1, 2016) was obtained from the Addis Ababa University Ethical committee.

Study Setting

This study was conducted at Menelik-II Hospital. Menelik II hospital is one of the largest hospitals in the country. Menelik-II Hospital is now the main health provider center that offers high-quality comprehensive health services to the patient from all over the region of Ethiopia and there are two main operation departments, from which ophthalmic operation room has six operation tables. One of these is pediatric operation room table, which on average, 1920 pediatric patients operated under general anesthesia per year. The study was conducted from January 25–March 25, 2017.

Study Participants

Patients of ASA class I and II, age ranging from 2 to 15 years and undergoing elective surgical procedures under GA using LMA were included in the study. Patients with hyper-reactive airway disease anticipated difficult airway, on regular sedatives and on β-blockers were excluded from the study.

Study Variables

In this study, the dependent variables were ease of LMA insertion and hemodynamic changes. The independent variables were socio-demographic and operative data (Age, Sex Weight, ASA, and Mallampati class) and another exposure variable (a type of anesthesia drugs used (ketofol vs. propofol)) Table 1.

Sample Size and Sampling Techniques Determination

StatCalc EPI info 7.1.1 (Fleiss) was used based on ease of LMA insertion conditions among two groups to calculate the sample size for each group. The following assumptions were considered to estimate the sample size required for the study. A 95% confidence level and 80% power, equal sample size for two groups, a proportion of subjects with poor insertion conditions were 41.66 and 18.33% in propofol (unexposed) and ketofol (exposed) group respectively in a recent study.[15,16] A total of 60 ASA I and II pediatric patients age 2–15 were assigned to each group.

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