NCT02562417

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.9 years

First QC Date

September 28, 2015

Last Update Submit

July 18, 2017

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Mean recovery time for T4/T1 ratio > 90% after sugammadex administration

    surgical procedure

Secondary Outcomes (2)

  • Mean recovery time for T4/T1 ratio > 80% after sugammadex administration

    surgical procedure

  • Mean recovery time for T4/T1 ratio > 70% after sugammadex administration

    surgical procedure

Study Arms (2)

No IV dexamethasone

PLACEBO COMPARATOR

Patients will receive an equivalent volume of normal saline.

Drug: Normal saline

IV dexamethasone

EXPERIMENTAL

Patients will receive 0.1 mg/kg of dexamethasone.

Drug: IV dexamethasone

Interventions

Normal salineDRUG
No IV dexamethasone
IV dexamethasoneDRUG
IV dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • contraindication to dexamethasone administration
  • contraindication to sugammadex administration
  • contraindication to rocuronium administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Interventions

Saline SolutionDexamethasone

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Regional Anaesthesia

Study Record Dates

First Submitted

September 28, 2015

First Posted

September 29, 2015

Study Start

June 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

CH(1)