NCT06454825

Effects of Antiemetic Agents in Orthognathic Surgery Patients

Effects of Combined Antiemetic Protocol For The Prevention Of Postoperative Nausea And Vomiting In Orthognathic Surgery: A Randomized Double Blinded Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Emesis, Postoperative
• Maxillofacial Abnormalities

Interventions

Type	Name	Description
DRUG	Intravenous drug	medications were applied intravenously to the groups 30 minutes before end of the procedure

Timeline

• Start date: 2020-04-14
• Primary completion: 2021-04-05
• Completion: 2021-04-05
• First posted: 2024-06-12
• Last updated: 2024-06-12

Locations

1 site across 1 country: Turkey (Türkiye)