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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
Singapore Health Services Pte Ltd,
31 Third Hospital Avenue,
#03-03 Bowyer Block C,
Singapore 168753.
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
We aimed to characterize and define the incidence and prevalence of postoperative residual curarization (PORC) in the post anaesthetic care unit (PACU) of our tertiary referral women’s centre in 250 patients after major gynaecological, breast and aesthetic surgery. Our primary outcome variable is the incidence of PORC in awake extubated patients 10 min post-PACU arrival, where a TOF ratio <0.9 is used as criteria for defining postoperative residual weakness. Secondary outcome measures studied are the presence of side effects (nausea and vomiting), adverse respiratory events, time to PACU discharge readiness and actual length of PACU stay.
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
Dr 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
Dr 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

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