Comparison of the effect of oral Aprepitant and Ondansetron injection individually and combining on postoperative nausea and vomiting after Laparoscopic cholecystectomy in women using general anesthesia
The aim of this study is compare the effects of Ondansetron and Aprepitant on postoperative nausea and vomiting in 18 to 50 years old female patients which have laparoscopic cholecystectomy under general anesthesia. Exclusion criteria contain catching systemic disease or to have age out of the range.
The study as a double blinded clinical trial will be done on 90 patients. Concurrent with operation anti nausea drug 4mg Ondansetron IV and placebo capsule is administered 1 hour before operation. In another group Aprepitant capsule 80mg 1 hour before operation with placebo ampule during operation and in third group Aprepitant before and Ondansetron during operation is administered. Nausea and vomiting in patients will be studied in 6 and 24 hours postoperative as early and late symptoms and is recorded in questionnaire. Patients information will be classified in separate tables and wil be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120831302N1
Registration date:2017-05-17, 1396/02/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-17, 1396/02/27
Registrant information
Name
Farhang Safarnejad
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 171 1079
Email address
safarnejhad.s@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research, Kurdistan University of Medical Sciences, Sanandaj, Kurdistan, Iran
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral Aprepitant and Ondansetron injection individually and combining on postoperative nausea and vomiting after Laparoscopic cholecystectomy in women using general anesthesia
Public title
The effect of oral Aprepitant and Ondansetron injection on postoperative nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women between 18 to 50 years old with ASA class 1 and 2 with at least 2 criteria of APFEL (female; nonsmoker; motion sickness or PONV history; using opioids 100mcg fentanyl or equivalent )
Exclusion criteria: women under 18 or greater than 50 years old; AA class 3 or more; cholecystectomy in other anesthesia; systemic disease like diabetes; asthma; cardiovascular; reflux, severe obesity; pregnancy; breast feeding; hepatic and renal disease; neuromuscular disease; psychotic disease; addiction; acute cholecystitis.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Pasdaran BLVD
City
Sanandaj
Postal code
6617713446
Approval date
2016-11-14, 1395/08/24
Ethics committee reference number
MUK.REC.1395.256
Health conditions studied
1
Description of health condition studied
nausea and vomitting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
nausea and vomitting
Timepoint
6 and 24 hours after operation
Method of measurement
VAS criteria
Secondary outcomes
1
Description
hospitalization period
Timepoint
at discharge time
Method of measurement
hospitalization days
Intervention groups
1
Description
group1: Ondancetron ampule 4mg intravenous after anesthetic induction and placebo capsule 1 hour before operation
Category
Treatment - Drugs
2
Description
group 2: Aprepitant capsule 80mg 1 hour before operation and placebo ampule (normal saline) after anesthetic induction is administered
Category
Treatment - Drugs
3
Description
group 3: Aprepitant capsule 80mg 1 hour before operation and Ondansetron 4mg intravenous after anesthetic induction is administered
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospitsl
Full name of responsible person
Reza Karami
Street address
Vakil Street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research, Kurdistan University of Medical Sciences
Full name of responsible person
Nasrin Khodamoradi
Street address
Pasdaran BLVD, Kurdistan University of Medical Sciences
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research, Kurdistan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Besat Hospital, Kurdistan University of Medical Sciences
Full name of responsible person
Reza Karami
Position
General Surgery Resident
Other areas of specialty/work
Street address
Vakil Street
City
Sanandaj
Postal code
Phone
+98 87 3322 8925
Fax
Email
reza_karami1367@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital, Kurdistan University of Medical Sciences
Full name of responsible person
Farhang Ssafarnejad
Position
General Surgeon
Other areas of specialty/work
Street address
Vakil Street
City
Sanandaj
Postal code
Phone
+98 87 3322 8925
Fax
Email
safarnejhad.s@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Besat Hospital, Kurdistan University of Medical Sciences
Full name of responsible person
Reza Karami
Position
General Surgery Resident
Other areas of specialty/work
Street address
Vakil Street
City
Sanandaj
Postal code
Phone
+98 87 3322 8925
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)