Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000371099
Ethics application status
Approved
Date submitted
4/05/2010
Date registered
10/05/2010
Date last updated
10/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
neuromuscular effect of rocuronium in patients with obstructive jaundice
Scientific title
A randomized trial to study whether neuromuscular effect of rocuronium is prolonged in patients with obstructive jaundice, in order to reduce the risk of postoperative residual neuromuscular block.
Secondary ID [1] 251695 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients with obstructive jaundice 257285 0
Condition category
Condition code
Anaesthesiology 257432 257432 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
rocuronium will be injected intravenously only once when the patient is in stale anesthesia. The dosage is 0.9 mg/kg, three times of 95% effective dose (0.3mg/kg).
Intervention code [1] 256421 0
Treatment: Drugs
Comparator / control treatment
patients without obstructive jaundice will also receive rocuronium intravenously only once when the patient is in stale anesthesia. The dosage is 0.9 mg/kg, three times of 95% effective dose (0.3mg/kg).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258356 0
The left ulnar nerve is stimulated at the wrist with square-wave, default stimuli of 0.2 ms duration, delivered in a train of four (TOF) mode at 2 Hz every 15 s and contraction of the ipstlateral adductor pollicis muscle is measured using acceleromyography (TOF WatchTM, Organon Ltd, Ireland).
25%, 50% and 75% recovery of twitch 1 (T1) in train-of-four (TOF) and recovery index are all prolonged.
Timepoint [1] 258356 0
When the ratio of train of four (TOFR) is above 80%, the stimulation will be terminated. This timepoint mean that the spontaneous recovery of the patient's adductor pollicis muscle and the rocuronium is well metabolized and excreted.
The ratio of train of four (TOFR) is the percentage of twitch 4:twitch 1 (T4:T1)
Secondary outcome [1] 264088 0
None
Timepoint [1] 264088 0
None

Eligibility
Key inclusion criteria
patients for upper abdominal surgery with or without obstructive jaundice
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age<65 yr or >18 yr; body mass index (BMI) <24.9 or >18.5; history of diabetes, cardiovascular, respiratory, or renal diseases; hepatic encephalopathy, psychiatric illnesses, or neuropathy; complication of acute cholangitis, gastrointestinal bleeding, or ascites; electrolyte or acid-base disturbance, sepsis; receiving drugs known to interfere with neuromuscular transmission.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2612 0
China
State/province [1] 2612 0
Country [2] 2613 0
China
State/province [2] 2613 0
Shanghai

Funding & Sponsors
Funding source category [1] 256908 0
Self funded/Unfunded
Name [1] 256908 0
Country [1] 256908 0
Primary sponsor type
Individual
Name
zhen-meng wang
Address
Department of Anesthesia and Intensive Care, Eastern Hepatobiliary Surgery Hospital, 225# Changhai Road, Shanghai, China. 200438.
Country
China
Secondary sponsor category [1] 256180 0
None
Name [1] 256180 0
Address [1] 256180 0
Country [1] 256180 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The primnary purpose of this study was to investigate whether the neuromuscular effect of rocuronium is prolonged in patients with obstructive jaundice.
We hypothesized that neuromuscular effect of rocuronium is prolonged in patients with obstructive jaundice, just as it does in patients with hepatic or renal dysfunction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31123 0
Address 31123 0
Country 31123 0
Phone 31123 0
Fax 31123 0
Email 31123 0
Contact person for public queries
Name 14370 0
zhen-meng wang
Address 14370 0
Department of Anesthesia and Intensive Care, Eastern Hepatobiliary Surgery Hospital, 225# Changhai Road, Shanghai, China. 200438.
Country 14370 0
China
Phone 14370 0
+8613601919501
Fax 14370 0
Email 14370 0
[email protected]
Contact person for scientific queries
Name 5298 0
zhen-meng wang
Address 5298 0
Department of Anesthesia and Intensive Care, Eastern Hepatobiliary Surgery Hospital, 225# Changhai Road, Shanghai, China. 200438.
Country 5298 0
China
Phone 5298 0
+8613601919501
Fax 5298 0
Email 5298 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
No additional documents have been identified.