Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000757819
Ethics application status
Approved
Date submitted
16/07/2012
Date registered
16/07/2012
Date last updated
16/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Ramosetron, low dose midazolam, and their combination for the prevention of postoperative nausea and vomiting in patients undergoing thyroidectomy
Scientific title
In patients undergoing thyroidectomy, which is more effective for the prevention of postoperative nausea and vomiting among ramosetron, low dose midazolam, and their combination?
Secondary ID [1] 280853 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 thyroidectomy 286920 0
Condition category
Condition code
Anaesthesiology 287250 287250 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before induction of anesthesia, ramosetron 0.3 mg combined with low dose midazolam(75 microg/kg) is injected
Intervention code [1] 285280 0
Treatment: Drugs
Intervention code [2] 285281 0
Prevention
Comparator / control treatment
Before induction of anesthesia, ramosetron 0.3 mg or low dose midazolam(75 microg/kg) is injected
Control group
Active

Outcomes
Primary outcome [1] 287529 0
Severity of nausea assessed using 10 point-verbal numerical rating scale(VNRS)
Timepoint [1] 287529 0
at 0hr, 6hr, 12hr, 24hr postoperatively
Primary outcome [2] 287530 0
Incidence of vomiting
Timepoint [2] 287530 0
at 0hr, 6hr, 12hr, 24hr postoperatively
Primary outcome [3] 287531 0
Rescue antiemetic recorded by nurse
Timepoint [3] 287531 0
at 0hr, 6hr, 12hr, 24hr postoperatively
Secondary outcome [1] 298344 0
Pain score assessed using 10 point-verbal numerical rating scale(VNRS)
Timepoint [1] 298344 0
at 0hr, 6hr, 12hr, 24hr postoperatively
Secondary outcome [2] 298345 0
fentanyl consumption recorded by nurse
Timepoint [2] 298345 0
at 0hr, 6hr, 12hr, 24hr postoperatively

Eligibility
Key inclusion criteria
patients undergoing thyroidectimy
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe impairment of bowel motility, insulin-dependent diabetes mellitus, pregnancy or breast feeding, administration of antiemetic medication within 24 h before operation, history of cardiovascular or respiratory disease, active alcohol or drug usage, obesity (body mass index > 35 kg/m2), impaired renal and/or hepatic function

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)
The details of the series are kept in a set of sealed envelopes, each bearing only the case number on the outside. After admitting into the operating room and just before the induction of anaesthesia, the numbered envelope was opened and the card inside determined which group the patient would be affiliated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization into one of the three groups was based on Excel random-number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
69
Accrual to date
Final
Recruitment outside Australia
Country [1] 4410 0
Korea, Republic Of
State/province [1] 4410 0

Funding & Sponsors
Funding source category [1] 285639 0
University
Name [1] 285639 0
Chung-Ang University
Country [1] 285639 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
Astellas pharma korea, INC.
Address
401 Hakdong-ro, Gangnam-gu Seoul, 135-766
Country
Korea, Republic Of
Secondary sponsor category [1] 284474 0
None
Name [1] 284474 0
Address [1] 284474 0
Country [1] 284474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287639 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 287639 0
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Ethics committee country [1] 287639 0
Korea, Republic Of
Date submitted for ethics approval [1] 287639 0
Approval date [1] 287639 0
01/06/2012
Ethics approval number [1] 287639 0
C2012074(769)

Summary
Brief summary
Postoperative nausea and vomiting (PONV) frequently develops in patients undergoing thyroidectomy, The present study was undertaken to compare the effects of ramosetron, low dose midazolam, and their combination on PONV in patients following total thyroidectomy. Patients were randomly assigned to one of three groups to receive antiemetics as follows: ramosetron 0.3 mg, low dose nidazolam 75microg/kg, or their combination. PONV, postoperative pain intensity, rescue antiemetics requirement, and side effects were assessed at 0, 6, 12, 24h postoperatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34443 0
Address 34443 0
Country 34443 0
Phone 34443 0
Fax 34443 0
Email 34443 0
Contact person for public queries
Name 17690 0
Hyun Kang
Address 17690 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 17690 0
Korea, Republic Of
Phone 17690 0
+82-2-6299-2571, 2579, 2586
Fax 17690 0
+82-2-6299-2585
Email 17690 0
[email protected]
Contact person for scientific queries
Name 8618 0
Hyun Kang
Address 8618 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 8618 0
Korea, Republic Of
Phone 8618 0
+82-2-6299-2571, 2579, 2586
Fax 8618 0
+82-2-6299-2585
Email 8618 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 AIRamosetron, midazolam, and combination of ramosetron and midazolam for prevention of postoperative nausea and vomiting: A prospective, randomized, double-blind study2013https://doi.org/10.1177/0300060513485864
N.B. These documents automatically identified may not have been verified by the study sponsor.