Sugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants

Brain Cancer Clinical Trial

Official title:

Sugammadex Given for the Reversal of Deep Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708056
• Other study ID #: KA 16-67
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2016
• Last updated: March 9, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in infant patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 12 Months

Eligibility

Inclusion Criteria:

• Patients between the ages of 1-12 month,

• ASA physical status 1-3 who underwent elective brain cancer surgery during general anesthesia were included in the study

Exclusion Criteria:

• younger than 1month or older than 12 months.

• hepatic or renal failure

• A history of allergy to study medication

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Cancer

Intervention

Drug:
• Sugammadex

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of sugammadex were assessed by using Train of four (TOF)		1 year	Yes