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

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.

Study Overview

• Status: Completed
• Conditions: Maxillofacial Abnormalities; Emesis, Postoperative
• Intervention / Treatment: Drug: Intravenous drug

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Granisetron group; one group received granisetron 3 mg drug	Drug: Intravenous drug; medications were applied intravenously to the groups 30 minutes before end of the procedure
Experimental: Granisetron and Metoclopramide group; one group received a combination of granisetron 3 mg and metoclopramide 10 mg drugs	Drug: Intravenous drug; medications were applied intravenously to the groups 30 minutes before end of the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: ÖZGE 3 ÖZYILMAZ, DDS, Bezmialem Vakif University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Actual): April 5, 2021
• Study Completion (Actual): April 5, 2021

Study Registration Dates

• First Submitted: June 1, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: metoclopramide; orthognathic surgery; granisetron; anti-emetic agent
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Congenital Abnormalities; Signs and Symptoms, Digestive; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Vomiting; Nausea; Postoperative Nausea and Vomiting; Maxillofacial Abnormalities
• Other Study ID Numbers: ozgedoganay.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients were anonymously recorded. Due to the data and patient's security, if it requested from the investigators, in that case we will decide.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No