Prevalance of sensitivity of immune system to the four named neuromuscular blocking drugs in patients undergoing anaesthesia.
Conditions
Interventions
Trade Name: Esmeron
Product Name: Esmeron
Product Code: PL 05003/0041
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Rocuronium Bromide
Concentration unit: mg/ml milligram(s)/millili
Sponsors
Royal Group Hospitals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the frequency of positive skin testing in subjects that exhibit no evidence of anaphylaxis following the administration of neuromuscular blocking drugs.;Secondary Objective: i) To determine the frequency of chlorhexidine sensitization in the study group. ii) To determine the frequency of sensitization to latex in the study group. iii) To determine the frequency of raised serum tryptase in the individuals that show evidence of positive skin testing. iv) To determine the frequency of cross-sensitization (ability of the immune system to recognize several drugs despite only being exposed to one previously) in the cohort. v) To determine the rate of sensitization to neuromuscular blocking drugs 3 days after administration. vi) To determine any correlation between Total IgE and sensitization in the study group. ;Primary end point(s): The frequency of positive skin testing in subjects that exhibit no evidence of anaphylaxis following the administration of neuromuscular blocking drugs. | — |
Countries
United Kingdom
Outcome results
None listed