Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04376541
• Collaborator: (none)
• Enrollment: 70
• Actual Duration (Months): 51

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fentanyl Adverse Reaction; Caudal Anesthesia	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 Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fast Tracking Impact on Fentanyl Consumption and Parents Satisfaction in Non Complex Cardiac Surgery
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. fentanyl consumption [during the procedure (corrective surgery)]

   amount of fentanyl used in microgram

2. parents satisfaction: questionnare [after discharge from the ICU up to 1 week]

   questionnare for parents satisfaction by early child communication

Secondary Outcome Measures

1. intensive care length of stay [after departure from operation room until ward discharge up to 3 weeks]

   number of days in ICU

2. hospital length of stay [from admission until home discharge up to 4 weeks]

   total number of days spent in hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gamal Adel Adelhameed, lecturer of anesthesia and intensive care and pain management, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04376541
• Other Study ID Numbers: s 43
• First Posted: May 6, 2020
• Last Update Posted: May 6, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Gamal Adel Adelhameed, lecturer of anesthesia and intensive care and pain management, Ain Shams University: fast track; congenital cardiac surgery; caudal; fentanyl
• Additional relevant MeSH terms: Fentanyl

Study Results

No Results Posted as of May 6, 2020