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Prophylactic effects of ondansetrone

Comparison of prophylactic effects of intravenous metochlopramide and ondansetrone on postoperative nausea and vomiting (PONV) in maxillofacial surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108147324N1
Enrollment
175
Registered
2012-07-18
Start date
2011-06-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillofacial operations: trauma-orthognathic surgery. 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

Interventions

Intervention 1: Patients in group Ob will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before surgery. Intervention 2: Patients in group Oa will receive a single dose of ondansetrone
Treatment - Drugs
Patients in group Ob will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before surgery
Patients in group Oa will receive a single dose of ondansetrone (0.15 mg/kg) 30 minutes before the end of surgery
Patients in group Mb will receive a single dose of metochlopramide (0.5 mg/kg) 30 minutes before surgery.
Patients in group Ma will receive a single dose of metochlopramide (0. 5 mg/kg) 30 minutes before the end of surgery.
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

Sponsors

Vice Chancellor for Research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.;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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hossein Dabbagh Asadolahi Pour

Tabriz university of medical sciences, Imam Reza hospital

hdabbagha@gmail.com+98 41 1666 1218

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026