Effects of Antiemetic Agents in Orthognathic Surgery Patients

Status Completed

Clinical Trial Summary

In an effort to prevent or treat consistently high rates of PONV following maxillofacial operations, several medications, techniques and multimodal protocols have been studied. In the present study, the investigators hypothesized that combining metoclopramide with granisetron will improve PONV incidence when compared with granisetrone alone.

Clinical Trial Description

Despite advances in anesthetic techniques and antiemetic drugs that accompany increasing awareness of anesthesia providers, postoperative nausea and vomiting (PONV) remains one of the most common problems after general anesthesia. PONV is one of the major problems leading to patient dissatisfaction, prolonged stay in postoperative care unit and hospital, readmissions and thus it can increase health care costs. In the studies performed in PONV prone patients and high-risk surgeries, as compared with other antiemetic medications, "setrons" provided lower nausea and vomiting incidence postoperatively, but were unable to completely prevent this "big little" problem.The blood in the stomach has been indicated as one of the major causes of PONV following maxillofacial surgery thus, using metoclopramide may relieve the complaints by evacuating this irritant. After institutional ethic committee and National Medicines, 66 consecutive patients, classified as ASA I and II physical status and aged between 18 and 60 years were included in the study. Apfel's simplified PONV risk score including female sex, history of motion sickness or PONV, smoking status and predicted use of postoperative opioids was recorded.Procedures were performed under general anesthesia. Patients in Group G received 3 mg granisetron (Neoset, Deva, Istanbul) and the patients in group GM received 3 mg granisetron + 10 mg metoclopramide (Metpamid, Sifar İlaç, Istanbul) 30 minutes before the end of operation intravenously. A nursing staff collected the data concerning PONV, VAS, systolic, diastolic and mean arterial pressures, heart rate, peripheral arterial saturation, total doses of drugs used, overall bleeding score, infused fluid volume, VAS, surgical procedure, duration of surgery and rescue antiemetics for nausea if applied for 24 hours. ;

Study Design

Related Conditions & MeSH terms

Maxillofacial Abnormalities
Postoperative Nausea and Vomiting

Clinical Trial Details

NCT number	NCT06454825
Study type	Interventional
Source	Bezmialem Vakif University
Contact
Status	Completed
Phase	Phase 4
Start date	April 14, 2020
Completion date	April 5, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.