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Completed

NCT Number: NCT06454825

Effects of Antiemetic Agents in Orthognathic Surgery Patients

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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Key information

Conditions

Emesis, Postoperative Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases Stomatognathic System Abnormalities Vomiting

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous drug

Drug

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

Primary outcomes

  1. Postoperative nausea and vomiting

    Time frame: 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 outcomes

  1. Visual analogue scale

    Time frame: 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.

  2. Systolic arterial pressure

    Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

    It was measured during the surgery.

  3. Diastolic arterial pressure

    Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

    It was measured during the surgery.

  4. Mean arterial pressure

    Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

    It was measured during the surgery.

  5. heart rate

    Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

    It was measured during the surgery.

  6. peripheral arterial saturation

    Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.

    It was measured during the surgery.

  7. total doses of drugs

    Time frame: before extubation

    It was recorded during the surgery.

  8. Bleeding amount

    Time frame: before extubation

    It was recorded at the end of the surgery.

  9. Infused fluid volume

    Time frame: before extubation

    It was recorded during the surgery.

  10. Duration of surgery

    Time frame: before extubation

    It was recorded at the end of the surgery.

  11. Rescue antiemetic

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Effects of Combined Antiemetic Protocol For The Prevention Of Postoperative Nausea And Vomiting In Orthognathic Surgery: A Randomized Double Blinded Clinical Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2024
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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