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Comparison of the Effect of Ondansetron, Dexamethasone and Their Combination in Reducing Nausea and Vomiting Following Laparoscopic Cholecystectomy

Protocol summary

Summary
Objective: Comparison of Ondansetron and Dexamethasone effect and also combination of these two drugs effect in prevention of nausea and vomiting caused by laparoscopic cholecystectomy in patients admitted to the Semnan Kowsar hospital. Study design: randomized (random blocks), single-blinded, placebo-uncontrolled, single-center, phase II clinical trials. Inclusion criteria: At least 18 years; patients in ASA Groups (one and two). Exclusion criteria: Gastroesophageal reflux disease; severe obesity; airway problems; pregnancy; lactation; liver or kidney disorders. Sample size, intervention, time of intervention, outcomes studied: 90 patients were admitted to Kowsar hospital, the patients were randomly divided into three groups, with 30 patients in each groups, Group A: 16 mg of dexamethasone was injected intravenously; Group B: 4 mg ondansetron was injected intravenously; group C: 4 mg ondansetron plus 8 mg dexamethasone were injected intravenously. After patient transferring to the operating room bed and primary activities, the antinausea drugs were prepared in identical with volume 2ml syringe by a medical student and then immediately administered before the first surgical incision by an anesthesiologist that who will be unaware of the drug. The anesthesia were performed with the same way in all three groups. The patients were extubated and transferred to the recovery room after making proper breathing, furthermore, the patient’s nausea and vomiting were checked during 6 and 24 hours after surgery. The patient's recovery period was recorded after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020725732N13
Registration date: 2017-05-01, 1396/02/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-09-13, 1395/06/23
Expected recruitment end date
2017-03-13, 1395/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Ondansetron, Dexamethasone and Their Combination in Reducing Nausea and Vomiting Following Laparoscopic Cholecystectomy
Public title
Comparison of the Effect of Ondansetron, Dexamethasone and Their Combination in Reducing Nausea and Vomiting Following Laparoscopic Cholecystectomy in patients referred to Semnan Kosar Hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: least 18 years; patients in Group ASA (one and two). Exclusion criteria: Gastroesophageal reflux; severe obesity; airway problem; pregnancy; lactation; liver or kidney disorders; a history of drug addiction; alcoholism; neuromuscular disorders; psychiatric disorders; diabetes, a history of systemic diseases (cardiovascular, respiratory and hypertension).
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2016-09-13, 1395/06/23
Ethics committee reference number
IR.SEMUMS.REC.1395.93

Health conditions studied

1

Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Nausea
Timepoint
In the recovery room, 6 and 24 hours after surgery.
Method of measurement
View and visit (registered in the check list)

2

Description
Vomit
Timepoint
In the recovery room, 6 and 24 hours after surgery.
Method of measurement
View and visit (registered in the check list)

3

Description
Recovery time
Timepoint
After laparoscopic cholecystectomy (from time of arrival to the recovery room)
Method of measurement
In minutes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: 30 cases of patients were injected 16 mg of dexamethasone intravenously based on a simple random sampling. Injection was performed by an anesthesiologist who will be unaware of the drugs type before the first surgery incision immediately. The anesthesia were performed with the same way in all three groups. Furthermore, the patient’s nausea and vomiting were checked during 6 and 24 hours after surgery. The patient's recovery period was recorded after surgery.
Category
Treatment - Drugs

2

Description
Intervention 2: 30 cases of patients were injected 4 mg of ondansetron intravenously based on a simple random sampling. Injection was performed by an anesthesiologist who will be unaware of the drugs type before the first surgery incision immediately. The anesthesia were performed with the same way in all three groups. Furthermore, the patient’s nausea and vomiting were checked during 6 and 24 hours after surgery. The patient's recovery period was recorded after surgery.
Category
Treatment - Drugs

3

Description
Intervention 3: 30 cases of patients were injected 4 mg of ondansetron plus 8 mg of dexamethasone intravenously based on a simple random sampling. Injection was performed by an anesthesiologist who will be unaware of the drugs type before the first surgery incision immediately. The anesthesia were performed with the same way in all three groups. Furthermore, the patient’s nausea and vomiting were checked during 6 and 24 hours after surgery. The patient's recovery period was recorded after surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital, Semnan University of Medical Sciences
Full name of responsible person
Babak Hosein Zadeh
Street address
Kosar Hospital, Street Amin, Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidy-Pour
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Babak Hosein Zadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Babak Hosein Zadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Babak Hosein Zadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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