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
Verified date | June 2024 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
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. |
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