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

Neuromuscular Blockade Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390507
• Other study ID #: PTC-II
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2006
• Last updated: September 2, 2010
• Start date: October 2006

Study information

• Verified date: September 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Procedure:
• Post-tetanic count frequency

Locations

Country	Name	City	State
Denmark	Dep. of Anesthesia, Rigshospitalet	Copenhagen
Denmark	Dep. of Anesthesia, Herlev hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first response to TOF stimulation (T1)
Secondary	Time to second response to TOF stimulation (T2)
Secondary	Time to first post-tetanic count (PTC)
Secondary	Number of post-tetanic count at first response to TOF
Secondary	Time to T1=25%
Secondary	Interval 25-75%
Secondary	Time to TOF 0.9
Secondary	Time to TOF 1.0