Effects of Antiemetic Agents in Orthognathic Surgery Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2021-04-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emesis, Postoperative Maxillofacial Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized double blinded clinical study

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Granisetron group

one group received granisetron 3 mg drug

Group Type ACTIVE_COMPARATOR

Intravenous drug

Intervention Type DRUG

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

Granisetron and Metoclopramide group

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

Group Type EXPERIMENTAL

Intravenous drug

Intervention Type DRUG

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

Interventions

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Intravenous drug

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes