A randomised assessor blinded study to examine the role of skin testing in the prediction of peri-operative anaphylaxis and its correlation with mast cell tryptase and total IgE. - Peri-operative screening for sensitization to NMDAs

• Conditions: Prevalance of sensitivity of immune system to the four named neuromuscular blocking drugs in patients undergoing anaesthesia.

• Registration Number: EUCTR2005-001622-91-GB
• Lead Sponsor: Royal Group Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-09
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

i) ASA class I-II
ii) Scheduled for elective surgery that involves anaesthesia and the use of neuromuscular blocking drugs and expected to last at least 1 hour.
iii) Scheduled for elective surgery with no anticipated large blood loss or fluid shifts
iv) Planned post-operative in patient stay to last at least four days.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

i) No previous history of anaphylaxis.
ii) No previous reaction to any of the medications used.
iii) Pregnancy.
iv) Acute exacerbation of any pre-existing disease.
v) Not on any steroid or anti-histamine medication at time of testing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified