Postoperative Nausea and VomitingPhase 4NCT02386059
Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia
A Phase 4 study testing Dexamethasone, Ondansetron and Dexamethasone + Ondansetron in people with Postoperative Nausea and Vomiting, run by University of Catania at 4 sites in Italy.
Trial summary
Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dexamethasone, Ondansetron and Dexamethasone + Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 4 sitesItaly
- Study dates
- Mar 2015to Sep 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to II
- Scheduled for vitrectomy under local anesthesia
Who cannot join
- Hypersensitivity to study drug or rescue medication
- Preoperative score for nausea greater than 4 out of 10 points
- Subjects who suffer from chronic nausea and/or vomiting
- Severe hepatic insufficiency (Child-Pugh score > 9)
- Other antiemetic within 12 hours prior to surgery
- Patients unable to undergo a local anesthetic
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- Subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease
- Psychotic illness or depression
- Addiction to illicit substances or alcohol
- Non-psychotic emotional disorders
- Pregnant or lactating
- Subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Polytechnic University of Marche
Ancona, The Marches
University of Catania
Catania, Sicily, 95125
Federico II University
Naples, Italy, 80131
MARIO ROMANO, professor, +39 081 5666780
University of Sassari
Sassari, Sardinia
About this study
Official title: A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia
Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences.
To date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia.
In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.
Read the detailed description
Patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3 pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery and 15 minutes before the end of surgery.
The syringes were prepared by a third, neutral person not involved in the perioperative care of the patient, immediately before the start of anesthesia.
All vitrectomy surgeries were performed, in each unit,under local anesthesia by a retrobulbar block.
Each patients was observed and treated during a period of 24 hours after the surgery. For patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a rescue dose of 4 mg ondansetron IV.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- PLACEBO, Dexamethasone, Ondansetron, Dexamethasone + Ondansetron
- Keywords
- ondansetron, dexamethasone, vitrectomy, local anesthesia
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLACEBODrug
received normal saline, intravenously
DexamethasoneDrug
4 mg, intravenously, at the start of surgery
OndansetronDrug
4 mg, intravenously, 15 minutes before the end of surgery.
Dexamethasone + OndansetronDrug
4 mg dexamethasone, intravenously at the start of surgery and 4 mg ondansetron intravenously 15 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO Group | Placebo comparator | Received normal saline Receives: Drug: PLACEBO |
| DEXAMETHASONE Group | Active comparator | Received 4 mg Dexamethasone. Receives: Drug: Dexamethasone |
| ONDANSETRON | Active comparator | Received 4 mg Ondansetron Receives: Drug: Ondansetron |
| DEXAMETHASONE + ONDANSETRON | Active comparator | Received 4mg Dexamethasone + 4mg Ondansetron Receives: Drug: Dexamethasone + Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery
Measured: 1-24 hours post-operatively
Secondary outcomes (4)
• Standardized score of nausea and/or vomiting severity if PONV occurs.
Measured: 1-24 hours post-operatively
• Pain score during the immediate post-operative period.
Measured: 1-24 hours post-operatively
• Number of antiemetic rescue medications given postoperatively.
Measured: 1-24 hours post-operatively
• Rates of known side effects.
Measured: 1-24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, REIBALDI MICHELE, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386059
- Sponsor's protocol ID
- UCatania
- Status last verified
- Mar 2015
- First submitted
- 5 Mar 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT02386059
- Acronym / sponsor ID
- UCatania
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- ondansetron, dexamethasone, vitrectomy, local anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 11 Mar 2015 (estimated)
- 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.
Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences.
To date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia.
In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.
Detailed description
Patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3 pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery and 15 minutes before the end of surgery.
The syringes were prepared by a third, neutral person not involved in the perioperative care of the patient, immediately before the start of anesthesia.
All vitrectomy surgeries were performed, in each unit,under local anesthesia by a retrobulbar block.
Each patients was observed and treated during a period of 24 hours after the surgery. For patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a rescue dose of 4 mg ondansetron IV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PLACEBO Group | Placebo comparator | Drug: PLACEBOReceived normal saline |
| DEXAMETHASONE Group | Active comparator | Drug: DexamethasoneReceived 4 mg Dexamethasone. |
| ONDANSETRON | Active comparator | Drug: OndansetronReceived 4 mg Ondansetron |
| DEXAMETHASONE + ONDANSETRON | Active comparator | Drug: Dexamethasone + OndansetronReceived 4mg Dexamethasone + 4mg Ondansetron |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to II
- Scheduled for vitrectomy under local anesthesia
Key exclusion criteria (12 listed)
- Hypersensitivity to study drug or rescue medication
- Preoperative score for nausea greater than 4 out of 10 points
- Subjects who suffer from chronic nausea and/or vomiting
- Severe hepatic insufficiency (Child-Pugh score > 9)
- Other antiemetic within 12 hours prior to surgery
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 |
|---|---|---|
| PLACEBOreceived normal saline, intravenously | Drug | PLACEBO Group |
| Dexamethasone4 mg, intravenously, at the start of surgery | Drug | DEXAMETHASONE Group |
| Ondansetron4 mg, intravenously, 15 minutes before the end of surgery. | Drug | ONDANSETRON |
| Dexamethasone + Ondansetron4 mg dexamethasone, intravenously at the start of surgery and 4 mg ondansetron intravenously 15 minutes before the end of surgery. | Drug | DEXAMETHASONE + ONDANSETRON |
Primary outcome
• Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery
Time frame: 1-24 hours post-operatively
4 secondary outcomes
• Standardized score of nausea and/or vomiting severity if PONV occurs.
Time frame: 1-24 hours post-operatively
• Pain score during the immediate post-operative period.
Time frame: 1-24 hours post-operatively
• Number of antiemetic rescue medications given postoperatively.
Time frame: 1-24 hours post-operatively
• Rates of known side effects.
Time frame: 1-24 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Ondansetron and Dexamethasone + Ondansetron in people with Postoperative Nausea and Vomiting, run by University of Catania at 4 sites in Italy.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MICHELE REIBALDI, Professor (+39 0953781291, mreibaldi@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery (time frame: 1-24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2015.