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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granisetron group | Active Comparator | one group received granisetron 3 mg drug |
|
| Granisetron and Metoclopramide group | Experimental | one group received a combination of granisetron 3 mg and metoclopramide 10 mg drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous drug | Drug | medications were applied intravenously to the groups 30 minutes before end of the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative nausea and vomiting | The primary outcome of interest in the present study was the incidence of PONV. | fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale | Visual analogue scale was used to record pain score. following the surgery. 0-10 point scale was used. 0 showed no pain, 10 showed worst pain status. | fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively |
| Systolic arterial pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ÖZGE 3 ÖZYILMAZ, DDS | Bezmialem Vakif University, Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Istanbul | Fatih | 34093 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39824505 | Derived | Doganay Ozyilmaz O, Bayburt KA, Alkan A, Uysal H. Effects of Combined Antiemetic Protocol for the Prevention of Postoperative Nausea and Vomiting in Orthognathic Surgery: A Randomized Double Blinded Clinical Study. J Oral Maxillofac Surg. 2025 Apr;83(4):429-438. doi: 10.1016/j.joms.2024.12.010. Epub 2024 Dec 27. |
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Patients were anonymously recorded. Due to the data and patient's security, if it requested from the investigators, in that case we will decide.
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D019767 | Maxillofacial Abnormalities |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D007260 | Infusion Pumps |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
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randomized double blinded clinical study
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It was measured during the surgery. |
| preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. |
| Diastolic arterial pressure | It was measured during the surgery. | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. |
| Mean arterial pressure | It was measured during the surgery. | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. |
| heart rate | It was measured during the surgery. | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. |
| peripheral arterial saturation | It was measured during the surgery. | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. |
| total doses of drugs | It was recorded during the surgery. | before extubation |
| Bleeding amount | It was recorded at the end of the surgery. | before extubation |
| Infused fluid volume | It was recorded during the surgery. | before extubation |
| Duration of surgery | It was recorded at the end of the surgery. | before extubation |
| Rescue antiemetic | It was recorded at the end of the follow-up period. | it was recorded until follow-up period ended and if applied it would be recorded. Between fully awake in ward and 24th hours postoperatively. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |