Effects of Antiemetic Agents in Orthognathic Surgery Patients

Maxillofacial Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06454825
• Other study ID #: ozgedoganay.001
• Status: Completed
• Phase: Phase 4
• Start date: April 14, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: June 2024
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maxillofacial Abnormalities
• Postoperative Nausea and Vomiting

Intervention

Drug:
• Intravenous drug
medications were applied intravenously to the groups 30 minutes before end of the procedure

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	heart rate	It was measured during the surgery.	preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
Secondary	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.
Secondary	total doses of drugs	It was recorded during the surgery.	before extubation
Secondary	Bleeding amount	It was recorded at the end of the surgery.	before extubation
Secondary	Infused fluid volume	It was recorded during the surgery.	before extubation
Secondary	Duration of surgery	It was recorded at the end of the surgery.	before extubation
Secondary	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.