Emesis, Postoperative, Maxillofacial Abnormalities
Conditions
Keywords
anti-emetic agent, orthognathic surgery, granisetron, metoclopramide
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.
Interventions
DRUGIntravenous drug
medications were applied intravenously to the groups 30 minutes before end of the procedure
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
randomized double blinded clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting | fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively | The primary outcome of interest in the present study was the incidence of PONV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic arterial pressure | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. | It was measured during the surgery. |
| Diastolic arterial pressure | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. | It was measured during the surgery. |
| Mean arterial pressure | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. | It was measured during the surgery. |
| heart rate | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. | It was measured during the surgery. |
| peripheral arterial saturation | preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation. | It was measured during the surgery. |
| Visual analogue scale | fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively | 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. |
| Bleeding amount | before extubation | It was recorded at the end of the surgery. |
| Infused fluid volume | before extubation | It was recorded during the surgery. |
| Duration of surgery | before extubation | It was recorded at the end of the surgery. |
| Rescue antiemetic | it was recorded until follow-up period ended and if applied it would be recorded. Between fully awake in ward and 24th hours postoperatively. | It was recorded at the end of the follow-up period. |
| total doses of drugs | before extubation | It was recorded during the surgery. |
Countries
Turkey (Türkiye)
Outcome results
None listed