Clinical trial of comparison of Ondansetron and Metoclopramide effect on postoperative nausea and vomiting in patients with appendisitis and cholecystitis
Objective: Comparing the efficacy of Ondansetron and Metoclopramide in the treatment of nausea and vomiting after appendectomy and cholecystectomy. Design and setting: A randomized; double-blind; clinical trial study; single center; clinical trial phase 3. In this study, 90 samples were selected and allocated into two intervention and control groups using block randomization method during 12 months.
Inclusion criteria: patients with appendicitis and cholecystitis that needs to surgery; ASA I or II; Age between 15 to 70 years old and approve to participate in study.
Exclusion criteria: Unstable hemodynamic; recent use of antiemetic drugs; allergy to Metoclopramide and Ondansetron.
Intervention: Control group received 15 mg Metoclopramide, single dose intravenously. Intervention group received 1 mg/kg Ondansetron, single dose intravenously. If the need analgesic, Diclofenak with 75 mg/IM is using.
Main outcome measures: 1) Nausea severity assessment at 1,6,12 and 24 hours after the drug injection using visual analogue scale;
2) Number of vomiting episodes from 1,6,12 and 24 hours after drug injection;
3) Need for excessive drug to reduce nausea and vomiting 1 hour after injection; 4) Adverse effects of drugs
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601232954N8
Registration date:2017-10-21, 1396/07/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-21, 1396/07/29
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of Ondansetron and Metoclopramide effect on postoperative nausea and vomiting in patients with appendisitis and cholecystitis
Public title
The comparison of Ondansetron and Metoclopramide effect on postoperative nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with appendicitis and cholecystitis that needs to surgery; ASA I or II; age between 15 to 70 years old; Patients satisfaction on participation in the study.
Exclusion criteria: Systolic blood pressure lower than 90 mmHg; Unstable hemodynamic; Opium addiction; history of uncontrolled diseases (Parkinson, Restlessness syndrome, Epilepsy, GI bleeding, Pheochromocytoma); Recent use of CNS depressant drugs; Recent use of antiemetic drugs; allergy to the drugs used in this study
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
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
Not used
Assignment
Parallel
Other design features
In this study the randomization was conducted with block randomization method .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Azad Islamic University, Shahroud Branch
Street address
Azad Islamic University, Shahroud
City
Shahroud
Postal code
3615111151
Approval date
2014-11-16, 1393/08/25
Ethics committee reference number
93/231
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
2
Description of health condition studied
Cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis
3
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea severity
Timepoint
1, 6,12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Number of vomiting
Timepoint
1, 6,12 and 24 hours after surgery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Pain severity
Timepoint
1 hour after surgery to 24 hours
Method of measurement
Visual Analogue Scale
2
Description
Need to excessive drugs
Timepoint
1 hour after surgery to 24 hours
Method of measurement
Observation
Intervention groups
1
Description
Intervention: These patients receive 1 milligram per kg Ondansetron(made in Shahredaru Pharmaceutical Company in Islamic Republic Of Iran) single dose;intravenously.
Category
Treatment - Drugs
2
Description
These patients receive 15 milligram Metoclopramide (made in Osveh Pharmaceutical Company in Islamic Republic Of Iran) single dose; intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr. Mehdi Ebrahimi
Street address
Imam Hossein hospital ,Shahroud , Iran
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad Islamic University, Shahroud Branch
Full name of responsible person
Dr. Abbasali Manafi
Street address
Azad Islamic University, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad Islamic University, Shahroud Branch
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
Shahroud University of Medical science
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Other areas of specialty/work
Street address
Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Postal code
3615111151
Phone
+98 23 3239 5054
Fax
+98 23 3239 4800
Email
mb.sohrabi@yahoo.com; mb.sohrabi@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical science
Full name of responsible person
ِDr. Mehdi Ebrahimi
Position
General Surgion
Other areas of specialty/work
Street address
Imam Hossein hospital, Shahroud, Iran
City
Shahroud
Postal code
3615111151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
drmebrahimi@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical science
Full name of responsible person
Dr.Mehdi Ebrahimi
Position
General Sergion
Other areas of specialty/work
Street address
Imam Hossein hospital, Shahroud, Iran
City
Shahroud
Postal code
3615111151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
drmebrahimi@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)