A comparative evaluation of Rabeprazol and Ranitidine in decreasing epigastric pain after vitrectomy in patients referred to Rasoul Akram hospital between 2012-2013
Objective: A comparative evaluation of Rabeprazol and Ranitidine in decreasing epigastric pain after vitrectomy
Patients and Method:
Inclusion criteria: ASA status I patients scheduled for elective vitrectomy surgery
Exclusion Criteria: Patients with gastrointestinal diseases and those receiving medication that may have altered gastric motility were excluded from the study. addiction, pregnancy, psychological disorders, BMI above 35
There are two groups in the study; we will assign 35 patients for each group randomly. in intervention group Rabeprazol Sodium (Iran Najo, 20 mg Entereic coated) will be administered the night before surgery and in control group Ranitidine (tablet, 150mg, Arya Co. Iran) will be administered the night before surgery.
Epigastric pain will be evaluated by Visual Analogue Scale (VAS) as primary outcome in both groups. This study will be finalized in 12 months in 2012-2013.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303105822N3
Registration date:2013-03-18, 1391/12/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-18, 1391/12/28
Registrant information
Name
Valiollah Hassani
Name of organization / entity
Department of Anesthesiology, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
valiollah_hassani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Tehran,Iran
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative evaluation of Rabeprazol and Ranitidine in decreasing epigastric pain after vitrectomy in patients referred to Rasoul Akram hospital between 2012-2013
Public title
Effect of Rabeprazol in decreasing epigastric pain after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA status I patients scheduled for elective vitrectomy surgery
Exclusion Criteria:
Patients with gastrointestinal diseases and those receiving medication that may have altered gastric motility were excluded from the study. addiction, pregnancy, psychological disorders, BMI above 35
Age
From 20 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Room 501, 5th Floor, Central Office of Tehran University of Medical Sciences, Keshavarz Bolvard
City
Tehran
Postal code
Approval date
2012-11-08, 1391/08/18
Ethics committee reference number
91.د.130.1924
Health conditions studied
1
Description of health condition studied
Reflux and epigastric pain
ICD-10 code
K21
ICD-10 code description
Gastro-oesophageal reflux disease
Primary outcomes
1
Description
Epigastric Pain
Timepoint
1, 2, 4 hour after surgery
Method of measurement
visual analog scale (VAS)
Secondary outcomes
1
Description
Heart Burn
Timepoint
1,2,4 Hours after surgery
Method of measurement
Questionnaire (yes/no)
Intervention groups
1
Description
intervention group:
Rabeprazol Sodium (Iran Najo, 20 mg Entereic coated) will be administered the night before surgery.
Category
Treatment - Drugs
2
Description
Control Group:
Ranitidine (tablet, 150mg, Arya Co. Iran) will be administered the night before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Hospital
Full name of responsible person
Valiollah Hassani
Street address
Niyayesh St, Sattarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Ghodrati
Street address
Firouzgar Hospital, Behafarin St. ,Valiasr Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Hazrat Rasoul Medical Center, Niayesh st, Sattarkhan ave
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
vhassani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Hazrat Rasoul Medical Center, Niayesh St, Sattarkhan ave
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
vhassani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Rohani
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Hazrat Rasoul Medical Center, Niayesh st, Sattarkhan ave,
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)