Assessment of time to return of spontaneous ventilation after administration of either suxamethonium or rocuronium followed by sugammadex in patients undergoing planned surgery.
Conditions
Interventions
Trade Name: BRIDION
Product Name: SUGAMMADEX
Pharmaceutical Form: Solution for injection
Other descriptive name: SUGAMMADEX
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
BELFAST HEALTH & SOCIAL CARE TRUST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) ASA class I-III ii) Patients able to give written informed consent iii) Patients requiring general anaesthesia iv) Patients aged 18 – 65 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) History of dementia or difficulty in providing informed consent ii) Patients with chronic obstructive pulmonary disease (COPD) iii) Patients with a history of ischaemic heart disease (IHD) iv) Patients with a haemoglobin concentration of less than 10g dl-1 v) Patients with a history of known difficulty in intubation or with an anticipated challenging airway vi) Pregnancy vii) Patients with a history of allergy to any of the medications used in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Length of time to resumption of spontaneous ventilation as indicated by visible diaphragmatic movement or decrease in oxygen saturation to = 90% before onset of spontaneous ventilation;Secondary Objective: (i) Frequency of desaturation to = 90% (ii) Length of time to movement of reservoir bag (iii) Length of time to first capnographic evidence of ventilation (iv) Incidence of adverse events in all groups ;Primary end point(s): The primary end point is the time to resumption of spontaneous ventilation after administration of suxamethonium or rocuronium followed by sugammadex. | — |
Countries
United Kingdom
Outcome results
None listed