Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction

Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction in Non Complex Cardiac Surgery

The investigators are measuring fentanyl consumption in micrograms used during anesthesia for patients on fast track congenital cardiac surgeries

Study Overview

• Status: Completed
• Conditions: Fentanyl Adverse Reaction; Caudal Anesthesia
• Intervention / Treatment: Drug: Fentanyl

Detailed Description

The investigators are measuring fentanyl consumed for both fast track and conventional corrective cardiac surgeries and also parents Parental Perceptions satisfaction with early child communication in ICU and impact of caudal anesthesia on extubation time our 2ry outcomes are the hospital and ICU length of stay

• Study Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with congenital cardiac anomaly for surgical correction from 3months to 18 years of age

Description

Inclusion Criteria:

• patients diagnosed with congenital cardiac anomaly for surgical correction.
• age limit: child 3months of age to 18 years

Exclusion Criteria:

patients with any o the following:

• emergency surgeries
• redo surgeries
• complex surgeries
• patients weight less than 3kg

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early extubation; the patients extubated in O.R or within 2 hours in the ICU	Drug: Fentanyl; amount of fentanyl used in both groups
late extubation; the patients extubated after 2 hours from O.R	Drug: Fentanyl; amount of fentanyl used in both groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fentanyl consumption	amount of fentanyl used in microgram	during the procedure (corrective surgery)
parents satisfaction: questionnare	questionnare for parents satisfaction by early child communication	after discharge from the ICU up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intensive care length of stay	number of days in ICU	after departure from operation room until ward discharge up to 3 weeks
hospital length of stay	total number of days spent in hospital	from admission until home discharge up to 4 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (ACTUAL): May 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: fentanyl; fast track; caudal; congenital cardiac surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: s 43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD Will be shared upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No