Time to resumption of spontaneous respiration in patients administered either suxamethonium or rocuronium followed by sugammadex - SUX/SUGAM

• Conditions: Assessment of time to return of spontaneous ventilation after administration of either suxamethonium or rocuronium followed by sugammadex in patients undergoing planned surgery.

• Registration Number: EUCTR2009-010840-33-GB
• Lead Sponsor: BELFAST HEALTH & SOCIAL CARE TRUST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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%<br>(ii)Length of time to movement of reservoir bag<br>(iii)Length of time to first capnographic evidence of ventilation<br>(iv)Incidence of adverse events in all groups<br>;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.