NCT00390507

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

September 6, 2010

Status Verified

September 1, 2010

Enrollment Period

3.5 years

First QC Date

October 19, 2006

Last Update Submit

September 2, 2010

Conditions

Neuromuscular Blockade

Keywords

AcceleromyographyTOF-WatchPosttetanic countTrain of fourNeuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • Time to first response to TOF stimulation (T1)

Secondary Outcomes (7)

  • 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

  • Time to T1=25%

  • Interval 25-75%

  • +2 more secondary outcomes

Interventions

Post-tetanic count frequencyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dep. of Anesthesia, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Dep. of Anesthesia, Herlev hospital

Herlev, Herlev, 2730, Denmark

Location

Study Officials

  • Casper C Kjaer, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 20, 2006

Study Start

October 1, 2006

Primary Completion

April 1, 2010

Last Updated

September 6, 2010

Record last verified: 2010-09

Locations

DK(2)