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 |
| Protocol serial number | 09005RM-CS |
| Sponsor | Belfast Health and Social Care Trust (UK) |
| Funder | Belfast Health and Social Care Trust (UK) (ref: 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled double-blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Suxamethonium, rocuronium, sugammadex |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Frequency of desaturation to less than or equal to 90% |
| Completion date | 01/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 90 |
| 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
- United Kingdom
- Northern Ireland
Study participating centre
Queen's University Belfast
Belfast
BT12 6BJ
United Kingdom
BT12 6BJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/03/2017: No publications found, verifying study status with principal investigator.
