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NCT02562417 Clinical Trial

Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex

Neuromuscular Blockade Clinical Trial

Official title:
Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02562417
Other study ID # CER 478/14
Secondary ID
Status Withdrawn
Phase Phase 4
First received September 28, 2015
Last updated July 18, 2017
Start date June 2016
Est. completion date May 2018

Study information
Verified date July 2017
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. The objective of this randomised controlled trial is to confirm in the clinical practice these preliminary results.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients scheduled to undergo microlaryngoscopy and ear-nose-throat endoscopic procedures

Exclusion Criteria:

- contraindication to dexamethasone administration

- contraindication to sugammadex administration

- contraindication to rocuronium administration

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Normal saline

• IV dexamethasone

Locations
Country Name City State
Switzerland Lausanne University Hospital Lausanne VAud

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean recovery time for T4/T1 ratio > 90% after sugammadex administration surgical procedure
Secondary Mean recovery time for T4/T1 ratio > 80% after sugammadex administration surgical procedure
Secondary Mean recovery time for T4/T1 ratio > 70% after sugammadex administration surgical procedure
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