Condition category
Surgery
Date applied
30/09/2009
Date assigned
14/10/2009
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rosemary Hogg

ORCID ID

Contact details

Department of Anaesthetics & Intensive Care Medicine
Queen's University Belfast
2nd Floor
Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

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 approved on the 24th August 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 below 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 measures

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

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

Department of Anaesthetics & Intensive Care Medicine
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

http://www.belfasttrust.hscni.net

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes