Modification of Posttetanic Count (PTC) for Monitoring De... | NCT00390507

Studies
Modification of Posttetanic Count (PTC) for Monitoring Deep Neuromuscular Block II

NCT00390507

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Sep 6, 2010Estimated

Enrollment

45Actual

Phase

Phase 4

Conditions

Neuromuscular Blockade

Interventions

Post-tetanic count frequency

Countries

Denmark

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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Apr 2010Actual

Completion Date

Not provided

First Submitted Date

Oct 19, 2006

First Submission Date that Met QC Criteria

Oct 19, 2006

First Posted Date

Oct 20, 2006Estimated

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

Sep 2, 2010

Last Update Posted Date

Sep 6, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to examine the relationship between post-tetanic count (PTC) and time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade induced by rocuronium.

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

45Actual

Name	Type	Description	Arm Group Labels	Other Names
Post-tetanic count frequency	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first response to TOF stimulation (T1)

Secondary Outcomes

Measure	Description	Time Frame
Time to second response to TOF stimulation (T2)
Time to first post-tetanic count (PTC)
Number of post-tetanic count at first response to TOF

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 1-3
General anaesthesia >1 hour
Surgery in supine position with possibility of monitoring the neuromuscular blockade at the thumb (n.ulnaris stimulation).
Written informed content

Exclusion Criteria:

Neuromuscular disorders, hepatic and renal dysfunction
Medication expected to interfere with the neuromuscular blocking agent
Allergy to any medication used during anaesthesia
Body weight less or exceeding 20% of the ideal body weight
Pregnancy or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Casper C Kjaer, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep. of Anesthesia, Rigshospitalet		Copenhagen	Copenhagen	2100	Denmark
Dep. of Anesthesia, Herlev hospital