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

ozgedoganay.001

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.

2020-04-14

2021-04-05

2021-04-05

Completed

Early phase I

66

Inclusion Criteria: * Undergoing orthognathic surgery * ASA I and II physical status * aged between 18 and 60 years * must be volunteer to take study drugs Exclusion Criteria: * Unable or unwilling to give informed consent * Underwent to genioplasty * Documented hypersensitivity to study drugs * Gastroesophageal reflux or hiatal hernia * Diabetes mellitus * Renal insufficiency * Pregnancy * Electrolyte imbalance * Neurological disease * Mental retardation * Prolonged QT interval.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized double blinded clinical study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}

2024-06-12