Comparison of prophylactic effects of intravenous metochlopramide and ondansetrone on postoperative nausea and vomiting (PONV) in maxillofacial surgery
(1) Objectives: comparison of prophylactic effects of intravenous metochlopramide and ondansetrone on postoperative nausea and vomiting (PONV) in maxillofacial surgery (2) Design: randomized, double blind (3) Setting and conduct: patients alocated in 5 therapeutic groups and assessed at 6 intervals regarding nausea and vomiting. (4) Participants including major eligibility criteria: Participants will be selected from patients in Imam Reza hospital, who require maxillofacial surgery because of trauma or developmental problems. Inclusion criteria: 18-50 years of age; Patients undergoing IMF. Exclusion criteria: Systemic diseases affecting nausea and vomiting; Brain trauma in traumatic patients; Clinical conditions indicating presence of factors for being placed in a high risk group; Duration of surgery more than 3 hours; Use of nausea- and vomiting-inducing drugs such as opiates. (5) Intervention: Patients in group Oa will receive a single dose of ondansetrone (0.15 mg per kg) 30 minutes before the end of surgery. Patients in group Ob will receive a single dose of ondansetrone (0.15 mg per kg) 30 minutes before surgery. Patients in group Mb will receive a single dose of metochlopramide (0.5 mg per kg) 30 minutes before surgery. Patients in group Ma will receive a single dose of metochlopramide (0.5 mg per kg) 30 minutes before the end of surgery.
Patients in group C (control group) will receive no prophylaxis and drugs before the end of surgery and metochlopramide will be routinely used PRN.
(6) main outcome measures (variables): nausea, vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108147324N1
Registration date:2012-07-18, 1391/04/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-18, 1391/04/28
Registrant information
Name
Saeed Nezafati
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 8240
Email address
nezafatis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic effects of intravenous metochlopramide and ondansetrone on postoperative nausea and vomiting (PONV) in maxillofacial surgery
Public title
Prophylactic effects of ondansetrone
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for maxillofacial surgery; 18-50 years of age; Patients undergoing IMF.
Exclusion criteria: systemic diseases affecting nausea and vomiting; brain trauma in traumatic patients, as a factor influencing nausea and vomiting; clinical conditions indicating presence of factors for being placed in a high risk group; duration of surgery more than 3 hours; use of nausea- and vomiting-inducing drugs such as opiates.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
175
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
Ethic committee of Tabriz university of medical sciences
Street address
Golgasht,Azadi street
City
Tabriz
Postal code
Approval date
2011-06-12, 1390/03/22
Ethics committee reference number
917
Health conditions studied
1
Description of health condition studied
Maxillofacial operations: trauma-orthognathic surgery
ICD-10 code
Y83.4
ICD-10 code description
Surgical operation and other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Nausea
Timepoint
On arrival at the ward (full consciousness),Thirty minutes after full consciousness,An hour after full consciousness Thirty minutes after PO (nearly 4.5 hours after full consciousness),Eight hours after full consciousness,. Twenty hours after surgery
Method of measurement
Recorded by inspection of nausea and asking after recovery
2
Description
Vomiting
Timepoint
On arrival at the ward (full consciousness),Thirty minutes after full consciousness,An hour after full consciousness Thirty minutes after PO (nearly 4.5 hours after full consciousness),Eight hours after full consciousness,. Twenty hours after surgery
Method of measurement
recorded by inspection of vomiting
Secondary outcomes
1
Description
Vertigo
Timepoint
On arrival at the ward (full consciousness),Thirty minutes after full consciousness,An hour after full consciousness Thirty minutes after PO (nearly 4.5 hours after full consciousness),Eight hours after full consciousness,. Twenty hours after surgery
Method of measurement
Inspection and asking from the patient
Intervention groups
1
Description
Patients in group Ob will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before surgery
Category
Treatment - Drugs
2
Description
Patients in group Oa will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before the end of surgery
Category
Treatment - Drugs
3
Description
Patients in group Mb will receive a single dose of metochlopramide (0.5 mg/kg) 30 minutes before surgery.
Category
Treatment - Drugs
4
Description
Patients in group Ma will receive a single dose of metochlopramide (0. 5 mg/kg) 30 minutes before the end of surgery.
Category
Treatment - Drugs
5
Description
Patients in group C (control group) will not receive any prophylaxis and drugs before surgery or at the end of surgery and metochlopramide will be used PRN after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of oral and maxillofacial surgery, Imam Reza hospital
Full name of responsible person
Dr. Saeed Nezafati
Street address
Golgasht Ave, Azadi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Faculty of health and nutrition, Tabriz university of medical sciences< Golgasht, Azadi str
City
Tabriz
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, Tabriz 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
Tabriz university of medical sciences, Imam Reza hospital
Full name of responsible person
Dr. Hossein Dabbagh Asadolahi Pour
Position
dentist(DDS) , senior resident of OMFS
Other areas of specialty/work
Street address
department of OMFS, Imam Rreza hospital,Ggolgasht ave, Azadi.st
City
Tabriz
Postal code
Phone
+98 41 1666 1218
Fax
Email
hdabbagha@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sceinces
Full name of responsible person
Dr.Saeed Nezafati
Position
associate professor of oral and maxillofacial surgery
Other areas of specialty/work
Street address
department of OMFS, dental faculty, Golgasht Ave, Azadi . St
City
Tabriz
Postal code
Phone
+98 41 1556 2352
Fax
Email
nezaf2000@yahoo.com nezafatis@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical sciences
Full name of responsible person
Dr.Saed nezafati
Position
associate professor of oral and maxillofacial surgery
Other areas of specialty/work
Street address
department of OMFS, dental faculty, Golgasht Ave, azadi St
City
Tabriz
Postal code
Phone
+98 411562352
Fax
Email
nezaf2000@yahoo.comnezafatis@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)