Comparison of two types of treatment which cause short acting muscle relaxation to determine which treatment allows patients to resume normal breathing in the shortest period of time
| ISRCTN | ISRCTN18103747 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18103747 |
| Secondary identifying numbers | 09005RM-CS |
- Submission date
- 30/09/2009
- Registration date
- 14/10/2009
- Last edited
- 07/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Rosemary Hogg
Scientific
Scientific
Department of Anaesthetics & Intensive Care Medicine
Queen's University Belfast
2nd Floor, Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Study information
| Study design | Randomised controlled double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Time to resumption of spontaneous respiration in patients administered either suxamethonium or rocuronium followed by sugammadex: a randomised double-blind controlled trial |
| Study objectives | 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(s) | Scotland A Research Ethics Committee, 24/08/2009, ref: 09/MRE00/29 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2009 |
| Completion date | 01/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 90 patients - 30 randomised to each group |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Queen's University Belfast
Belfast
BT12 6BJ
United Kingdom
BT12 6BJ
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Grosvenor Road
Belfast
BT12 6BJ
Northern Ireland
United Kingdom
| Website | http://www.belfasttrust.hscni.net |
|---|---|
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
Belfast Health and Social Care Trust (UK) (ref: 09005RM-CS)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/03/2017: No publications found, verifying study status with principal investigator.
