Emesis, PostoperativePhase 4NCT06454825
Effects of Antiemetic Agents in Orthognathic Surgery Patients
A Phase 4 study testing Intravenous drug in people with Emesis, Postoperative and Maxillofacial Abnormalities, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Emesis, Postoperative, Maxillofacial Abnormalities
- What is being tested?
- Intravenous drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2020to 5 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergoing orthognathic surgery
- ASA I and II physical status
- aged between 18 and 60 years
- must be volunteer to take study drugs
Who cannot join
- Unable or unwilling to give informed consent
- Underwent to genioplasty
- Documented hypersensitivity to study drugs
- Gastroesophageal reflux or hiatal hernia
- Diabetes mellitus
- Renal insufficiency
Show all 11Show fewer
- Pregnancy
- Electrolyte imbalance
- Neurological disease
- Mental retardation
- Prolonged QT interval.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: Effects of Combined Antiemetic Protocol For The Prevention Of Postoperative Nausea And Vomiting In Orthognathic Surgery: A Randomized Double Blinded Clinical Study
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.
Read the 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.
- Conditions
- Emesis, Postoperative, Maxillofacial Abnormalities
- Being tested
- Intravenous drug
- Keywords
- anti-emetic agent, orthognathic surgery, granisetron, metoclopramide
- Medical subject headings
- Postoperative Nausea and Vomiting, Maxillofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous drugDrug
medications were applied intravenously to the groups 30 minutes before end of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Granisetron group | Active comparator | one group received granisetron 3 mg drug Receives: Drug: Intravenous drug |
| Granisetron and Metoclopramide group | Experimental | one group received a combination of granisetron 3 mg and metoclopramide 10 mg drugs Receives: Drug: Intravenous drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
The primary outcome of interest in the present study was the incidence of PONV.
Measured: fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively
Secondary outcomes (11)
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.
Measured: fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively
Systolic arterial pressure
It was measured during the surgery.
Measured: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
Diastolic arterial pressure
It was measured during the surgery.
Measured: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
Mean arterial pressure
It was measured during the surgery.
Measured: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
heart rate
It was measured during the surgery.
Measured: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
peripheral arterial saturation
It was measured during the surgery.
Measured: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
total doses of drugs
It was recorded during the surgery.
Measured: before extubation
Bleeding amount
It was recorded at the end of the surgery.
Measured: before extubation
Infused fluid volume
It was recorded during the surgery.
Measured: before extubation
Duration of surgery
It was recorded at the end of the surgery.
Measured: before extubation
Rescue antiemetic
It was recorded at the end of the follow-up period.
Measured: it was recorded until follow-up period ended and if applied it would be recorded. Between fully awake in ward and 24th hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start14 Apr 2020
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emesis, PostoperativeStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blinded clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Özyılmaz, Bezmialem Vakif University
- Investigators
- ÖZGE 3 ÖZYILMAZ, DDS, Principal investigator, Bezmialem Vakif University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454825
- Sponsor's protocol ID
- ozgedoganay.001
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients were anonymously recorded. Due to the data and patient's security, if it requested from the investigators, in that case we will decide.
Publications
Doganay Ozyilmaz O, Bayburt KA, Alkan A, Uysal H. Effects of Combined Antiemetic Protocol for the Prevention of Postoperative Nausea and Vomiting in Orthognathic Surgery: A Randomized Double Blinded Clinical Study. J Oral Maxillofac Surg. 2025 Apr;83(4):429-438. doi: 10.1016/j.joms.2024.12.010. Epub 2024 Dec 27.
PubMed 39824505
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Antiemetic Protocol For The Prevention Of Postoperative Nausea And Vomiting In Orthognathic Surgery: A Randomized Double Blinded Clinical Study
- ClinicalTrials.gov ID
- NCT06454825
- Acronym / sponsor ID
- ozgedoganay.001
- Conditions
- Emesis, Postoperative, Maxillofacial Abnormalities
- Keywords
- anti-emetic agent, orthognathic surgery, granisetron, metoclopramide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blinded clinical study
| Arm | Type | Receives |
|---|---|---|
| Granisetron group | Active comparator | Drug: Intravenous drugone group received granisetron 3 mg drug |
| Granisetron and Metoclopramide group | Experimental | Drug: Intravenous drugone group received a combination of granisetron 3 mg and metoclopramide 10 mg drugs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Undergoing orthognathic surgery
- ASA I and II physical status
- aged between 18 and 60 years
- must be volunteer to take study drugs
Key exclusion criteria (11 listed)
- Unable or unwilling to give informed consent
- Underwent to genioplasty
- Documented hypersensitivity to study drugs
- Gastroesophageal reflux or hiatal hernia
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous drugmedications were applied intravenously to the groups 30 minutes before end of the procedure | Drug | Granisetron and Metoclopramide group, Granisetron group |
Primary outcome
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.
11 secondary outcomes
Visual analogue scale
Time frame: fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively
Systolic arterial pressure
Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
Diastolic arterial pressure
Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
Mean arterial pressure
Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
heart rate
Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
peripheral arterial saturation
Time frame: preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.
total doses of drugs
Time frame: before extubation
Bleeding amount
Time frame: before extubation
Infused fluid volume
Time frame: before extubation
Duration of surgery
Time frame: before extubation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 39824505Doganay Ozyilmaz O, Bayburt KA, Alkan A, Uysal H. Effects of Combined Antiemetic Protocol for the Prevention of Postoperative Nausea and Vomiting in Orthognathic Surgery: A Randomized Double Blinded Clinical Study. J Oral Maxillofac Surg. 2025 Apr;83(4):429-438. doi: 10.1016/j.joms.2024.12.010. Epub 2024 Dec 27.
- Individual participant dataSharing planned: No. Patients were anonymously recorded. Due to the data and patient's security, if it requested from the investigators, in that case we will decide.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ÖZGE 3 ÖZYILMAZ, DDS principal investigator
Bezmialem Vakif University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous drug in people with Emesis, Postoperative and Maxillofacial Abnormalities, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting (time frame: fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.