Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001357741
Ethics application status
Approved
Date submitted
9/12/2013
Date registered
11/12/2013
Date last updated
11/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incidence of postoperative residual curarization in the post-anaesthesia recovery unit
Scientific title
A study on the incidence and prevalence of postoperative residual curarization (PORC) in the post anaesthetic care unit (PACU) in female patients who underwent a general anaesthetic and received neuromuscular blocking drug (NMBD) for major gynaecological, breast , reconstructive or aesthetic surgery.
Secondary ID [1] 283730 0
Nil
Universal Trial Number (UTN)
Trial acronym
Incidence of PORC in PACU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative residual curarization 290699 0
Condition category
Condition code
Anaesthesiology 291068 291068 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The incidence of PORC in awake extubated patients 10 min post-PACU arrival. (defined as a nerve stimulation Train Of Four ratio <0.9 for postoperative residual weakness.)
Intervention code [1] 288425 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291061 0
Our primary outcome variable was the incidence of PORC in awake extubated patients 10 min post-PACU arrival. ( A TOF ratio <0.9 was used as criteria for defining postoperative residual weakness.)
Timepoint [1] 291061 0
Within 10min of PACU arrival for each participant
Secondary outcome [1] 305905 0
PACU side effects (symptoms of nausea as reported by participants, and actual witnessed episodes of vomiting by PACU staff)
Timepoint [1] 305905 0
Monitored throughout duration of each participant's PACU stay.
Secondary outcome [2] 305906 0
Adverse respiratory events (upper airway obstruction requiring intervention, bronchospasm, aspiration of gastric or oropharyngeal contents, episodes of oxygen saturation below 93%, hypoxemia requiring supplemental oxygen, need for tracheal reintubation). These outcomes are observed and/or reported by PACU nurses.
Timepoint [2] 305906 0
Monitored throughout duration of each participant's PACU stay
Secondary outcome [3] 305907 0
Time to PACU discharge readiness
Timepoint [3] 305907 0
time deemed medically appropriate for patients to leave the PACU
Secondary outcome [4] 305908 0
Actual PACU length of stay
Timepoint [4] 305908 0
Time from arrival to actual departure from the PACU.

Eligibility
Key inclusion criteria
ASA I-III patients who underwent a general anaesthetic for major gynaecological, breast , reconstructive or aesthetic surgery, in whom a neuromuscular blocking drug was administered.
Minimum age
21 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
< 21 years, had underlying neuromuscular disease, use of medication known to interfere with neuromuscular transmission.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We based our sample size calculation on data of Murphy and colleagues [ref: Murphy GS, Anesthesiology 2008] who observed a 30% incidence of PORC, and Butterly et al.[ ref: Butterly A,BJA2010] who found 22% incidence of PORC that was associated with prolonged PACU discharge times. Assuming an approximate 25% incidence of PORC, it was calculated that 50 patients with and 200 patients without PORC would provide a >80% power to detect a 10% difference in PACU length of stay with a standard deviation of 20%.
Data will be tested for normal distribution by means of the Kolmogorov-Smirnov test. Normally distributed data will be reported as a mean (standard deviation) and other continuous data reported as median (inter-quartile range). IBM SPSS version 19 will be used for statistical analysis. For comparison of means/medians, Students T test or Mann Whitney U test will be used as appropriate. Proportional data will be compared using the Chi-squared test or Fisher’s Exact test (eg. presence of complications such as nausea, vomiting and oyxgen desaturation).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/12/2013
Actual
3/12/2013
Date of last participant enrolment
Anticipated
20/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 5670 0
Singapore
State/province [1] 5670 0
Singapore

Funding & Sponsors
Funding source category [1] 288411 0
Self funded/Unfunded
Name [1] 288411 0
Country [1] 288411 0
Primary sponsor type
Individual
Name
Dr Wendy H.L.Teoh
Address
KK Women's & Children's Hospital,
100 Bukit Timah Road, Singapore 229899.
Country
Singapore
Secondary sponsor category [1] 287112 0
None
Name [1] 287112 0
Address [1] 287112 0
Country [1] 287112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290290 0
Singhealth Centralised Institutional Review Board D
Ethics committee address [1] 290290 0
Ethics committee country [1] 290290 0
Singapore
Date submitted for ethics approval [1] 290290 0
31/10/2013
Approval date [1] 290290 0
21/11/2013
Ethics approval number [1] 290290 0
CIRB 2013/949/D

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44854 0
Dr Wendy H.L. Teoh
Address 44854 0
Department of Women's Anaesthesia,
KK Women's & Children's Hospital,
100 Bukit Timah Road, Singapore 229899.
Country 44854 0
Singapore
Phone 44854 0
+6563941081
Fax 44854 0
+6562912661
Email 44854 0
[email protected]
Contact person for public queries
Name 44855 0
Wendy H.L. Teoh
Address 44855 0
Department of Women's Anaesthesia,
KK Women's & Children's Hospital,
100 Bukit Timah Road, Singapore 229899.
Country 44855 0
Singapore
Phone 44855 0
+6563941081
Fax 44855 0
+6562912661
Email 44855 0
[email protected]
Contact person for scientific queries
Name 44856 0
Wendy H.L. Teoh
Address 44856 0
Department of Women's Anaesthesia,
KK Women's & Children's Hospital,
100 Bukit Timah Road, Singapore 229899.
Country 44856 0
Singapore
Phone 44856 0
+6563941081
Fax 44856 0
+6562912661
Email 44856 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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