Clinical trial NCT06454825: Effects of Antiemetic Agents in Orthognathic Surgery Patients
Official title: Effects of Combined Antiemetic Protocol For The Prevention Of Postoperative Nausea And Vomiting In Orthognathic Surgery: A Randomized Double Blinded Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emesis, Postoperative
Maxillofacial Abnormalities
Keywords: anti-emetic agent
orthognathic surgery
granisetron
metoclopramide
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blinded clinical study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively
Secondary outcomes:
measure: Visual analogue scale
timeFrame: fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively
measure: Systolic arterial pressure
timeFrame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
measure: Diastolic arterial pressure
timeFrame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
measure: Mean arterial pressure
timeFrame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
measure: heart rate
timeFrame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
measure: peripheral arterial saturation
timeFrame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
measure: total doses of drugs
timeFrame: before extubation
measure: Bleeding amount
timeFrame: before extubation
measure: Infused fluid volume
timeFrame: before extubation
measure: Duration of surgery
timeFrame: before extubation
measure: Rescue antiemetic
timeFrame: it was recorded until follow-up period ended and if applied it would be recorded. Between fully awake in ward and 24th hours postoperatively.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University, Faculty of Dentistry
name: ÖZGE 3 ÖZYILMAZ, DDS
role: PRINCIPAL_INVESTIGATOR
References: