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Effect of intravenous dexamethazone on nausea and vomitting after laparoscopic cholecyctecmoy operation

Protocol summary

Summary
(1) Objective: to assess the effect of intravenous dexamethasone for prevention of nausea and vomiting after laparoscopic cholecystectomy in patients, (2) Design: randomized, double-blind, placebo-controlled, single-center, phase two trials, (3) Setting and conduct: injection of 8 milligram dexamethasone intravenously 30 minutes to an hour before surgery in patient group and 2 milliliter of saline in controls. After that, questioning patients about complain of nausea and vomiting and recording in the questionnaire. During this time, if they complain of nausea and vomiting, 10 miligram metoclopramide will be administered intravenously, (4) Participants including major eligibility criteria: all patients with billiary colics and uncomplicated cholelithiasis undergoing laparoscopic cholecystectomy referring Zahedan Ali-ebn Abi Talib Hospital; Major eligibility criteria: consent to participate in the study; no intake of steroid drugs 48 hours before surgery; not diabetic; no contraindication of dexamethasone usage; not pregnant; Major exclusion criteria: diabetes; contraindications of dexamethasone; pregnancy, (5) Intervention: injection of dexamethasone before surgery, (6) main outcome measures (variables): nausea and vomiting after laparoscopic cholecystectomy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121325515N1
Registration date: 2016-05-21, 1395/03/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Yaha Ehsanollahi
Name of organization / entity
Zahedan Medical University of Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
ehsanollahi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-02-18, 1394/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous dexamethazone on nausea and vomitting after laparoscopic cholecyctecmoy operation
Public title
Effect of intravenous dexamethazone on nausea and vomitting after cholecyctecmoy
Purpose
Treatment
Inclusion/Exclusion criteria
Terms of Inclusion: consent to participate in the study; no intake of steroid drugs 48 hours before surgery; not diabetic; no contraindication of dexamethasone intake; not pregnant Terms of exclusion: no consent to participate in the study; intake of steroid drugs 48 hours before surgery; diabetic; contraindication of dexamethasone intake; pregnancy
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 130
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
Ethics Committee of Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan Medical University of Science, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2015-06-19, 1394/03/29
Ethics committee reference number
IR.zaums.res.1394.329

Health conditions studied

1

Description of health condition studied
Cholecystitis
ICD-10 code
K81, K81-0
ICD-10 code description
Cholecystitis

Primary outcomes

1

Description
Nausea
Timepoint
Up to 24 hours after surgery in intervals of every 4 hours
Method of measurement
Questioning patients about complain of nausea and recorded in the questionnaire

2

Description
Vomitting
Timepoint
Up to 24 hours after surgery in intervals of every 4 hours
Method of measurement
Questioning patients about complain of vomiting and recorded in the questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: administration single dose of 8 milligram dexamethasone intravenously 30 minutes to an one hour before surgery
Category
Treatment - Drugs

2

Description
Control group: administration single dose of 2 mililiter normal saline intravenously 30 minutes to an one hour before surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali-ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Yahya Ehsanollahi
Street address
Surgery Department, Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
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, Zahedan 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
Zahedan Medical University
Full name of responsible person
Yahya Ehsanollahi
Position
Surgery Residence
Other areas of specialty/work
Street address
Surgery Department, Ali-ebn Abi Taleb Hospital, Salamat Blvd, Dr.Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5794
Fax
Email
ehsanollahi@zaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan Medical University
Full name of responsible person
Dr. Alireza Khazaee
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
ُSurgery Department, Ali-ebn Abi Taleb Hospital, Salamt Blvd, Dr.Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5583
Fax
Email
Alirezakhazaee@zaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Yahya Ehsanollahi
Position
Surgery Resident
Other areas of specialty/work
Street address
Surgery Department, Ali-ebn Abi Taleb Hospital, Salamat Blvd., Dr.Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Postal code
Phone
00
Fax
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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