Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000902796
Ethics application status
Approved
Date submitted
9/08/2013
Date registered
13/08/2013
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Palonosetron and aprepitant for prevention of postoperative nausea and vomiting in patient undergoing laparoscopic gynecology surgery.
Scientific title
In patients undergoing laparoscopic gynecologic surgery, which is more effective for the prevention of postoperative nausea and vomiting between palonosetron and aprepitant.
Secondary ID [1] 282994 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative nausea and vomiting in patients undergoing laparoscopic gynecologic surgery 289820 0
Condition category
Condition code
Anaesthesiology 290173 290173 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
before 1 hour to induction of anesthesia aprepitant 40 mg was given to patients by oral
Intervention code [1] 287708 0
Treatment: Drugs
Comparator / control treatment
palonosetron 0.075 mg was intravascular injected imediate after induction of anesthesia
Control group
Active

Outcomes
Primary outcome [1] 290202 0
severity of nausea assessed using 100 point-visual analogue scale(VAS)
Timepoint [1] 290202 0
at time of waking from anaesthesia 0hr, 2hr, 6hr, 24hr, 48hr
Primary outcome [2] 290203 0
incidence of vomiting
Timepoint [2] 290203 0
at time of waking from anaesthesia 0hr, 2hr, 6hr, 24hr, 48hr
Primary outcome [3] 290204 0
rescue antiemetics recorded by nurse
Timepoint [3] 290204 0
at time of waking from anaesthesia0hr, 2hr, 6hr, 24hr, 48hr
Secondary outcome [1] 304095 0
pain score assessed using 100 point-visual analogue scale
Timepoint [1] 304095 0
at time of waking from anaesthesia 0hr, 2hr, 6hr, 24hr, 48hr
Secondary outcome [2] 304096 0
fentanyl consumption recorded by nurse
Timepoint [2] 304096 0
at time of waking from anaesthesia 0hr, 2hr, 6hr, 24hr, 48hr
Secondary outcome [3] 304097 0
rescue analgeics recorded by nurse
Timepoint [3] 304097 0
at time of waking from anaesthesia 0hr, 2hr, 6hr, 24hr, 48hr

Eligibility
Key inclusion criteria
patients undergoing laparoscopic gynecologic surgery
Minimum age
20 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, 60 years of age or older and under 20 years old, weight 45kg or less, or more than 100kg, more than American society of Anesthesiologist grade three , history of previous postoperative nausea and vomiting, history of motion sickness, smokers, patient of serious cardiovascular system, kidney, liver, and hematological abnormalities.

Study design
Purpose of the study
Prevention
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2011
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
30/09/2013
Date of last data collection
Anticipated
Actual
30/09/2013
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 5288 0
Korea, Republic Of
State/province [1] 5288 0

Funding & Sponsors
Funding source category [1] 287763 0
University
Name [1] 287763 0
Chung-ang university
Country [1] 287763 0
Korea, Republic Of
Primary sponsor type
University
Name
Chung-ang university
Address
224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755
Country
Korea, Republic Of
Secondary sponsor category [1] 286491 0
None
Name [1] 286491 0
Address [1] 286491 0
Country [1] 286491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289710 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 289710 0
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Ethics committee country [1] 289710 0
Korea, Republic Of
Date submitted for ethics approval [1] 289710 0
Approval date [1] 289710 0
07/09/2011
Ethics approval number [1] 289710 0
C2011088(538)

Summary
Brief summary
Postoperative nausea and vomiting (PONV) frequently develops in patients undergoing laparoscopic gynecologic surgery, The present study was undertaken to compare the effects of palanosetron and aprepitant on PONV in patients following laparoscopic gynecologic surgery. Patients were randomly assigned to one of two groups to receive antiemetics as follows: palanosetron 0.075 mg or aprepitant 40 mg. PONV, postoperative pain intensity, rescue antiemetics requirement, and side effects were assessed at 0, 2, 6, 24, 48 hr postoperatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42074 0
Prof Chongwha Baek
Address 42074 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 42074 0
Korea, Republic Of
Phone 42074 0
+82-2-6299-2579
Fax 42074 0
+82-2-6299-2585
Email 42074 0
[email protected]
Contact person for public queries
Name 42075 0
Prof Chongwha Baek
Address 42075 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 42075 0
Korea, Republic Of
Phone 42075 0
+82-2-6299-2579
Fax 42075 0
+82-2-6299-2585
Email 42075 0
[email protected]
Contact person for scientific queries
Name 42076 0
Prof Chongwha Baek
Address 42076 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 42076 0
Korea, Republic Of
Phone 42076 0
+82-2-6299-2579
Fax 42076 0
+82-2-6299-2585
Email 42076 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
SourceTitleYear of PublicationDOI
Dimensions AIPalonosetron and aprepitant for the prevention of postoperative nausea and vomiting in patients indicated for laparoscopic gynaecologic surgery: a double-blind randomised trial2014https://doi.org/10.1186/1471-2253-14-68
N.B. These documents automatically identified may not have been verified by the study sponsor.