Protocol summary

Summary
To evaluate the prophylactic anti-emetic effect of dexamethasone we are going to run a double blinded placebo controlled clinical trial in Shahid Mostafa Khomeini Hospital, Tehran, Iran. In this study all patients with an age ranging 18 to 60 years, who are undergoing general anesthesia for elective laparoscopic cholecystectomy and consent to enroll in this study, will participate. However patients who have a history of motion sickness, any intestinal diseases or those who had received any anti-emetic agents within 24h before surgery will be excluded. Target sample size for this study is 160 patients and these enrolled patients will be allocated randomly to three groups of intervention, control intervention and placebo. Patients in intervention group will receive 8 mg of dexamethasone intravenously just before induction of anesthesia while those who are in control group will receive 10 mg of metoclopramide and those who are in placebo group only receive Normal Saline intravenously. For all these patients each episodes of post-operative vomit or sensation of post-operative nausea will be recorded 7 times during first 24 hour after surgical recovery without knowledge of if or which anti-emetic agents the patient had received. The anesthetic condition for all enrolled patient will be standardized. Laparoscopic cholecystectomies will perform as a standard procedure with pre-operative cholangiography and will be similar for all patients. The duration of the surgery, anesthesia, and CO2 insufflation will be recorded as well.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112088329N1
Registration date: 2012-01-06, 1390/10/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-06, 1390/10/16
Registrant information
Name
Amin Mohamadi
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 5948
Email address
a_mohamadi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Mostafa Khomeini Hospital, Shahed UniversityMD dissertation
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2012-03-12, 1390/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic anti-emetic effect of Dexamethasone in patients undergoing elective laparoscopic cholecystectomy in comparison with Metoclopramide and placebo.
Public title
Effect of Dexamethasone on prophylaxis of nausea and vomiting after laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Patients and age ranging 18 to 60 years who undergo general anesthesia for elective laparoscopic cholecystectomy in Mostafa Khomeini hospital. Exclusion criteria: Patients who have a history of motion sickness; Patients who have any intestinal diseases ;Patients who had received any anti-emetic agents within 24h before surgery; pregnant or breast-feeding women; patients who have evidence of hepatic dysfunction
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 160
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
Shahed University,Faculty of Medicine
Street address
Shahid Mostafa KHomeini Hospital,Italia St. , Felestin SQ
City
Tehran
Postal code
Approval date
2008-08-20, 1387/05/30
Ethics committee reference number
p162/78

Health conditions studied

1

Description of health condition studied
Nausea and Vomiting after cholecystectomy
ICD-10 code
K91.5
ICD-10 code description
Postcholecystectomy syndrome

2

Description of health condition studied
Post-Operative Vomiting
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery

Primary outcomes

1

Description
Episodes of post-operative Vomit
Timepoint
Time 0 until 24 hours after recovery form General anesthesia
Method of measurement
Asking from patients

Secondary outcomes

1

Description
sensation of post-operative nausea
Timepoint
0 -24 hours after recovery from general anesthesia
Method of measurement
visual scale

Intervention groups

1

Description
Ampul Dexamethasone 8 mg IV for intervention group
Category
Prevention

2

Description
Ampul Metoclopramide 10mg IV for control group
Category
Prevention

3

Description
Ampul Normal Saline (0.9%) IV
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Alireza Khalaj
Street address
Shahid Mostafa Khomeini Hospital, Italia St, Felestin Sq, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Deputy of Research
Street address
Mostafa Khomeini Hospital, Italia St, Felestin Sq.
City
Tehran
Grant name
اعتبار مربوط به پایان نامه ی پزشکی ، دانشکده پزشکی ، دانشگاه شاهد.
Grant code / Reference number
p 162/78
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Tehran University of Medical Science
Full name of responsible person
Amin Mohamadi
Position
MD
Other areas of specialty/work
Street address
Students’ Scientific Research Center, 3rd Floor, Faculty of Medicine, Tehran University of Medical Science, Pour Sina St, Ghods St , Enghelab Av
City
Tehran
Postal code
Phone
+98 21 6649 5948
Fax
Email
a_mohamadi@student.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam-Khomeini Hospital Complex,Tehran University of Medical Science
Full name of responsible person
Seyed Rouholah Miri
Position
MD
Other areas of specialty/work
Street address
Department of surgery, Imam-Khomeini Hospital Complexl, Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6652 1006
Fax
Email
drsrmiri@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Students’ Scientific Research Center, Tehran University of Medical Science
Full name of responsible person
Amin Mohamadi
Position
MD
Other areas of specialty/work
Street address
Students’ Scientific Research Center, 3rd Floor, Faculty of Medicine, Tehran University of Medical Science, Pour Sina St, Ghods St , Enghelab Av
City
Tehran
Postal code
Phone
+98 21 6649 5948
Fax
+98 21 6641 8588
Email
a_mohamadi@student.tums.ac.ir
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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