Effects of Antiemetic Agents in Orthognathic Surgery Patients

NCT06454825 | Completed Phase 4

• 1 other identifier: ozgedoganay.001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emesis, Postoperative; Maxillofacial Abnormalities

Keywords

anti-emetic agent; orthognathic surgery; granisetron; metoclopramide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Visual analogue scale

  fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively

• Systolic arterial pressure

  preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

• Diastolic arterial pressure

  preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

• Mean arterial pressure

  preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

• heart rate

  preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

Study Arms (2)

Granisetron group

ACTIVE COMPARATOR

one group received granisetron 3 mg drug

Drug: Intravenous drug

Granisetron and Metoclopramide group

EXPERIMENTAL

one group received a combination of granisetron 3 mg and metoclopramide 10 mg drugs

Drug: Intravenous drug

Interventions

Intravenous drug DRUG

medications were applied intravenously to the groups 30 minutes before end of the procedure

Granisetron and Metoclopramide group; Granisetron group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing orthognathic surgery
• ASA I and II physical status
• aged between 18 and 60 years
• must be volunteer to take study drugs

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Maxillofacial Abnormalities

Interventions

Infusion Pumps

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• ÖZGE 3 ÖZYILMAZ, DDS

  Bezmialem Vakif University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized double blinded clinical study

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 12, 2024
• Study Start: April 14, 2020
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)