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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390507
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : September 6, 2010
Information provided by:
Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Procedure: Post-tetanic count frequency Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : October 2006
Actual Primary Completion Date : April 2010

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

Secondary Outcome Measures :
  1. Time to second response to TOF stimulation (T2)
  2. Time to first post-tetanic count (PTC)
  3. Number of post-tetanic count at first response to TOF
  4. Time to T1=25%
  5. Interval 25-75%
  6. Time to TOF 0.9
  7. Time to TOF 1.0

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390507

Dep. of Anesthesia, Rigshospitalet
Copenhagen, Denmark, 2100
Dep. of Anesthesia, Herlev hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Casper C Kjaer, MD Rigshospitalet, Denmark Identifier: NCT00390507     History of Changes
Other Study ID Numbers: PTC-II
First Posted: October 20, 2006    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: September 2010

Keywords provided by Rigshospitalet, Denmark:
Posttetanic count
Train of four
Neuromuscular blockade