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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06454825
Other study ID # ozgedoganay.001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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