The aim of this study is to compare the efficacy of Ondansetron, Midazolam and Metoclopramide with placebo in preventing PONV following strabismus surgery. Inclusion Criteria : All candidates of strabismus surgery under general anesthesia with ASA class I-II. Exclusion criteria :any hypersensitivity to Ondansetrone; Metoclopramide Or Midazolam; any event causing change in anesthesia technique or ICU admission or death of the patient.
One hundred and sixty patients will be allocated with simple randomization in 4 groups of 40 : " ON" group will receive Ondansetrone 0.05 mg/kg, Group "MT" will receive Metoclopramide 0.15 mg/kg, Group "MD" will receive Midazolam 0.03 mg/kg intravenously and "CT" group will receive the solution of NaCl 0.9% as placebo infused with the same volume and the same manner 30 minutes before the end of surgery. The study will be designed as blinded in a way that the physician who evaluate the data will be different from the one who prescribes the premeditation. The patients will be evaluated for nausea, vomiting, need and dosage of anti-emetic drugs, time of liquid and solid diet tolerance, drug complications and satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011920588N5
Registration date:2017-06-30, 1396/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Darioush Moradi Farsani
Name of organization / entity
Isfahan Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 5555
Email address
dmoradi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-01-21, 1395/11/02
Expected recruitment end date
2017-03-22, 1396/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial forcomparing of Ondansetrone, Metoclopramide And Midazolam for PONV prophylaxis in patients undergoing Strabismus surgery
Public title
Nausea and vomiting afterstabismus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : All candidates of strabismus surgery under general anesthesia with American Society Of Anesthesiologists (ASA) class I-II.
Exclusion Criteria : Documented psychiatric disorders; any hypersensitivity to Ondansetrone, Metoclopramide or Midazolam; history of opium, alcohol, cigarette or benzodiazepines addiction؛ BMI over 25; pregnancy; chronic cough; history of malignant hyperthermia; history of using of any anti emetic drug 24 hours before surgery;Any event causing change in anesthesia technique or ICU admission or death of the patient.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
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
Isfahan University Of Medical Sciences
Street address
Islamic Republic Of Iran
City
Isfahan
Postal code
8174675731
Approval date
2016-03-12, 1394/12/22
Ethics committee reference number
ir.mui.rec.1394.3.1053
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
k20-k31(k3
ICD-10 code description
Diseases of oesophagus, stomach and duodenum
Primary outcomes
1
Description
Vomiting
Timepoint
In recovery, first and second 6 hours and 12 hour s later
Method of measurement
Frequency
2
Description
Nausea
Timepoint
iIn Recovery, First And Second 6 Hours And 12 Hours Later
Method of measurement
VAS (visual analogous score)
Secondary outcomes
1
Description
First time of solid and liquid diet toleranse
Timepoint
During the first 24 hours after anesthesia
Method of measurement
Hour
2
Description
Total dose of antiemetic drug used
Timepoint
During The First 24 Hours After Anesthesia
Method of measurement
Milligram
3
Description
Drug complications
Timepoint
During The First 24 Hours After Anesthesia
Method of measurement
Frequency
Intervention groups
1
Description
Intervention Group : " ON" group will receive Ondansetrone 0.05 mg/kg.
Category
Prevention
2
Description
Placebo Group : "CT" group will receive the solution of NACL 0.9% as Placebo.
Category
Treatment - Drugs
3
Description
Intervention group : " MT" group will receive Metoclopramide 0.15 mg/kg intravenously.
Category
Treatment - Drugs
4
Description
Intervention group :" MD" group will receive Midazolam 0.03 mg/kg Intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz University Hospital
Full name of responsible person
Darioush Morad iFarsani-asistent professor of anesthesia and critical care
Street address
Department of anesthesia and critical care, Alzahra university hospital, Sofeh Bulvar, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciense
Full name of responsible person
Dr Mehdi Nematbakhsh, Deputy Center Chaiman
Street address
Deputy center, Isfahan university of medical sciences, Sofeh Bulvar, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University Of Medical Sciense
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
Isfahan University Of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Asistant professor of Anesthesia and Critical care
Other areas of specialty/work
Street address
Department of Anesthesia and Critical care, Alzahra university hospital, Sofeh Bulvar, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Phone
+49 31362 5555
Fax
+98 36684510
Email
dmoradi@med.mui.ac.ir
Web page address
Anesthesiology@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Asistant professor of Anesthesia and Critical care
Other areas of specialty/work
Street address
Department of Anesthesia and critical Care, Alzahra University hospital, Sofeh Bulvar, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Phone
+98 313625555
Fax
+98 36684510
Email
dmoradi@med.mui.ac.ir
Web page address
Anesthesiology@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Asistant Professor of anesthesia and critical care
Other areas of specialty/work
Street address
Department of Anesthesia and Critical care, Alzahra university hospita, Sofeh Bulvar, Isfahan, Iran
City
Isafahan
Postal code
8174675731
Phone
+49 31362 5555
Fax
+98 36684510
Email
dmoradi@med.mui.ac.ir
Web page address
Anesthesiology@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)