Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09005RM-CS
Study information
Scientific title
Time to resumption of spontaneous respiration in patients administered either suxamethonium or rocuronium followed by sugammadex: a randomised double-blind controlled trial
Acronym
Study hypothesis
There is no differece in the time to resumption of breathing or incidence of desaturation in patients receiving either suxamethonium or rocuronium followed by one of two doses of sugammadex.
Ethics approval
Scotland A Research Ethics Committee, 24/08/2009, ref: 09/MRE00/29
Study design
Randomised controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Routine general anaesthesia
Intervention
After pre-oxygenation, patients will be randomised to one of three groups for the administration of either: suxamethonium 1 mg/kg, rocuronium 1 mg/kg followed by sugammadex 10 mg/kg or rocuronium 1 mg/kg followed by sugammadex 16 mg/kg. Sugammadex will be administered 3 minutes after rocuronium; 0.9% saline will be administered at this time in the suxamethonium group to maintain blinding.
Intervention type
Drug
Phase
Not Applicable
Drug names
Suxamethonium, rocuronium, sugammadex
Primary outcome measure
Length of time to resumption of spontaneous ventilation as indicated by visible diaphragmatic movement or decrease in oxygen saturation to less than or equal to 90% before onset of spontaneous ventilation
Secondary outcome measures
1. Frequency of desaturation to less than or equal to 90%
2. Length of time to movement of reservoir bag
3. Length of time to first capnographic evidence of ventilation
4. Incidence of adverse events in all groups
Overall trial start date
01/09/2009
Overall trial end date
01/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. American Society of Anaesthesiologists (ASA) class I - III
2. Patients able to give written informed consent
3. Patients requiring general anaesthesia
4. Patients aged 18 - 65 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90 patients - 30 randomised to each group
Participant exclusion criteria
1. History of dementia or difficulty in providing informed consent
2. Patients with chronic obstructive pulmonary disease (COPD)
3. Patients with a history of ischaemic heart disease (IHD)
4. Patients with a haemoglobin concentration of less than 10 g/dl
5. Patients with a history of known difficulty in intubation or with an anticipated challenging airway
6. Pregnancy
7. Patients with a history of allergy to any of the medications used in the study
Recruitment start date
01/09/2009
Recruitment end date
01/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's University Belfast
Belfast
BT12 6BJ
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Belfast Health and Social Care Trust (UK) (ref: 09005RM-CS)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list