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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00390507
First received: October 19, 2006
Last updated: September 2, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Neuromuscular Blockade
Procedure: Post-tetanic count frequency
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Time to first response to TOF stimulation (T1)

Secondary Outcome Measures:
  • 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%
  • Time to TOF 0.9
  • Time to TOF 1.0

Enrollment: 45
Study Start Date: October 2006
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390507

Locations
Denmark
Dep. of Anesthesia, Rigshospitalet
Copenhagen, Denmark, 2100
Dep. of Anesthesia, Herlev hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Casper C Kjaer, MD Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00390507     History of Changes
Other Study ID Numbers: PTC-II
Study First Received: October 19, 2006
Last Updated: September 2, 2010
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Acceleromyography
TOF-Watch
Posttetanic count
Train of four
Neuromuscular blockade

ClinicalTrials.gov processed this record on November 25, 2014