Impact of iv Dexamethasone on Reversal of Rocuronium-indu... | NCT02562417

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

NCT02562417

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Withdrawn

Last Update Posted

Jul 21, 2017Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Neuromuscular Blockade

Interventions

Normal saline
IV dexamethasone

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change of practice in the department

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

May 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

Sep 28, 2015

First Submission Date that Met QC Criteria

Sep 28, 2015

First Posted Date

Sep 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2017

Last Update Posted Date

Jul 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eric Albrecht, Program Director, Regional Anaesthesia, Centre Hospitalier Universitaire VaudoisPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire VaudoisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Normal saline	Drug		No IV dexamethasone
IV dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean recovery time for T4/T1 ratio > 90% after sugammadex administration		surgical procedure

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lausanne University Hospital		Lausanne	Canton of Vaud	1011	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution
D003907	Dexamethasone

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided