Laparoscopic SurgeryPhase 3NCT05439798
Effect of Palonosetron, Ondansetron and Dexamethasone in the Prevention of Postoperative Nausea and Vomiting
A Phase 3 study testing Ondansetron+Dexamethasone, Palonosetron+Dexamethasone and Dexamethasone in people with Laparoscopic Surgery and Pediatrics, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative nausea and vomiting (PONV) is an important outcome for the patient; patients generally rate PONV as worse than postoperative pain. The term PONV is typically used to describe nausea and/or vomiting or retching in the post-anesthetic care unit or within 24 hours postoperatively. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Laparoscopic Surgery, Pediatrics, Nausea and Vomiting, Postoperative
- What is being tested?
- Ondansetron+Dexamethasone, Palonosetron+Dexamethasone and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 31 May 2023
- Phase
- Phase 3
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Class I-II,
- Between the ages of 7-18,
- Patients with written informed consent from themselves and their parents
Who cannot join
- Allergic to study drugs,
- Taking antiemetic drugs 24 hours before the operation,
- Gastroesophageal reflux disease,
- Body mass index (BMI) >35 kg/m 2,
- In the period of menstruation,
- Receiving cancer chemotherapy in the last four weeks,
- Allergy to NSAIDs,
- Patients with bronchial asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Palonosetron + Dexamethazone, Ondansetron + Dexamethazone and Dexametazone Alone Against Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Laparoscopic Surgery
Postoperative nausea and vomiting (PONV) is an important outcome for the patient; patients generally rate PONV as worse than postoperative pain. The term PONV is typically used to describe nausea and/or vomiting or retching in the post-anesthetic care unit or within 24 hours postoperatively. Postoperative nausea and vomiting usually resolves or is treated without sequelae, but may require unexpected hospitalization and delay recovery room discharge. In the prophylaxis of PONV, ondansetron is one of the first widely used 5-HT3 receptor antagonists. Palonosetron, on the other hand, is a second generation 5-HT3 receptor antagonist with a half-life of 40 hours and higher receptor binding affinity. In addition, dexamethasone is another class of drugs that has emerged as a potentially useful prophylaxis for patients who are a corticosteroid and are at high risk of PONV with minimal side effects. However, a multimodal approach rather than antiemetic prophylaxis with a single pharmacological agent is described as a good way to reduce PONV, especially in high-risk cases. Conducted a previous systematic review and meta-analysis of the addition of dexamethasone to various 5-HT3 antagonists; however, it included only one study of palonosetron + dexamethasone. Since then, several meta-analyses have been performed on the efficacy of the combination of palonosetron and dexamethasone. This study was designed to find out the incidence of PONV by comparing the efficacy of the combination of palonosetron-dexamethasone, ondansetron-dexamethasone and dexamethasone alone for the prevention of PONV in patients undergoing pediatric laparoscopic surgery.
Read the detailed description
This study will be conducted with the data to be obtained from the Anesthesiology Surgery Form and Pediatric Surgery Service Forms in 66 patients aged 7-18 years, after the approval of Local Ethics Committee, Faculty of Medicine, Selcuk University. The patıents will be randomized ınto 3 groups. Patients in Group OD (n = 22) (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg-1). For this group of patients, ondansetron (0.1 mg.kg-1) (5 ml) will be prepared and will be named No: 1. It will be administered at the 8th and 16th hours postoperatively. In Group PD (n = 22) (Group palonosetron+dexamethasone), patients will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). In Group D (n = 22) (Group Dexamethasone) iv only dexamethasone (0.5 mg.kg-1) will be given. For the patients in Group PD and Group D, normal saline (SF) (5 ml solution) will be prepared for intravenous administration and will be named No: 2 and 3, respectively, and will be administered again at the 8th and 16th hours. The reason why we give SF here is to provide drug blanking, but not to give active drug, since the half-life of palonasetron and dexamethasone is long, up to 36 hours. The files of the patients will be examined and demographic data. For the primary purpose of this study, PONV values will be evaluated at 2, 6, 12, 24, 48, and 72 hours postoperatively. The intensity of nausea (0 = no nausea, 10 = worst possible nausea) will be rated on a verbal numerical rating scale (VNRS). The severity of nausea and vomiting will be classified as mild (1-3), moderate (4-6) and severe (7-10) according to VNRS scores. Secondary endpoints, time of taking first rescue antiemetic and total dose of rescue antiemetic, and complications (dizziness, headache, and arrhythmia) will be recorded.
- Conditions
- Laparoscopic Surgery, Pediatrics, Nausea and Vomiting, Postoperative, Antiemetics, Therapeutic Use
- Being tested
- Ondansetron+Dexamethasone, Palonosetron+Dexamethasone, Dexamethasone
- 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.
Ondansetron+DexamethasoneDrug
The patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg) The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1).
The patients In Group D (Group Dexamethasone) will be given iv only dexamethasone (0.5 mg.kg-1)
Palonosetron+DexamethasoneDrug
The patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg) The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1).
The patients In Group D (Group Dexamethasone) will be given iv only dexamethasone (0.5 mg.kg-1)
DexamethasoneDrug
Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Group OD (Group ondansetron+dexamethasone) | Active comparator | The patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg-1). Receives: Drug: Ondansetron+Dexamethasone |
| Group PD (Group palonosetron+dexamethasone) | Active comparator | The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). Receives: Drug: Palonosetron+Dexamethasone |
| Group D (Group Dexamethasone) | Placebo comparator | The patients in Group D (Group Dexamethasone) will be given intravenous (iv) dexamethasone (0.5 mg.kg-1). Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of palonosetron, ondansetron and dexamethasone in postoperative nausea and vomiting
The primary endpoint of this study was to find the incidence of PONV among the three groups.
Measured: 72 hours
Secondary outcomes (3)
The time to first rescue antiemetic intake
The Secondary endpoints were the time to first rescue antiemetic intake
Measured: 72 hours
The total amount of antiemetic use
the total amount of antiemetic use
Measured: 72 hours
The complications
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jun 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Selcuk 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, double-blind, controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Cicekci, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439798
- Sponsor's protocol ID
- farukcicekci6
- Status last verified
- Jun 2022
- First submitted
- 18 May 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Palonosetron + Dexamethazone, Ondansetron + Dexamethazone and Dexametazone Alone Against Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT05439798
- Acronym / sponsor ID
- farukcicekci6
- Conditions
- Laparoscopic Surgery, Pediatrics, Nausea and Vomiting, Postoperative, Antiemetics, Therapeutic Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 30 Jun 2022 (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.
Postoperative nausea and vomiting (PONV) is an important outcome for the patient; patients generally rate PONV as worse than postoperative pain. The term PONV is typically used to describe nausea and/or vomiting or retching in the post-anesthetic care unit or within 24 hours postoperatively. Postoperative nausea and vomiting usually resolves or is treated without sequelae, but may require unexpected hospitalization and delay recovery room discharge. In the prophylaxis of PONV, ondansetron is one of the first widely used 5-HT3 receptor antagonists. Palonosetron, on the other hand, is a second generation 5-HT3 receptor antagonist with a half-life of 40 hours and higher receptor binding affinity. In addition, dexamethasone is another class of drugs that has emerged as a potentially useful prophylaxis for patients who are a corticosteroid and are at high risk of PONV with minimal side effects. However, a multimodal approach rather than antiemetic prophylaxis with a single pharmacological agent is described as a good way to reduce PONV, especially in high-risk cases. Conducted a previous systematic review and meta-analysis of the addition of dexamethasone to various 5-HT3 antagonists; however, it included only one study of palonosetron + dexamethasone. Since then, several meta-analyses have been performed on the efficacy of the combination of palonosetron and dexamethasone. This study was designed to find out the incidence of PONV by comparing the efficacy of the combination of palonosetron-dexamethasone, ondansetron-dexamethasone and dexamethasone alone for the prevention of PONV in patients undergoing pediatric laparoscopic surgery.
Detailed description
This study will be conducted with the data to be obtained from the Anesthesiology Surgery Form and Pediatric Surgery Service Forms in 66 patients aged 7-18 years, after the approval of Local Ethics Committee, Faculty of Medicine, Selcuk University. The patıents will be randomized ınto 3 groups. Patients in Group OD (n = 22) (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg-1). For this group of patients, ondansetron (0.1 mg.kg-1) (5 ml) will be prepared and will be named No: 1. It will be administered at the 8th and 16th hours postoperatively. In Group PD (n = 22) (Group palonosetron+dexamethasone), patients will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). In Group D (n = 22) (Group Dexamethasone) iv only dexamethasone (0.5 mg.kg-1) will be given. For the patients in Group PD and Group D, normal saline (SF) (5 ml solution) will be prepared for intravenous administration and will be named No: 2 and 3, respectively, and will be administered again at the 8th and 16th hours. The reason why we give SF here is to provide drug blanking, but not to give active drug, since the half-life of palonasetron and dexamethasone is long, up to 36 hours. The files of the patients will be examined and demographic data. For the primary purpose of this study, PONV values will be evaluated at 2, 6, 12, 24, 48, and 72 hours postoperatively. The intensity of nausea (0 = no nausea, 10 = worst possible nausea) will be rated on a verbal numerical rating scale (VNRS). The severity of nausea and vomiting will be classified as mild (1-3), moderate (4-6) and severe (7-10) according to VNRS scores. Secondary endpoints, time of taking first rescue antiemetic and total dose of rescue antiemetic, and complications (dizziness, headache, and arrhythmia) will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- prospective, randomized, double-blind, controlled
| Arm | Type | Receives |
|---|---|---|
| Group OD (Group ondansetron+dexamethasone) | Active comparator | Drug: Ondansetron+DexamethasoneThe patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg-1). |
| Group PD (Group palonosetron+dexamethasone) | Active comparator | Drug: Palonosetron+DexamethasoneThe patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). |
| Group D (Group Dexamethasone) | Placebo comparator | Drug: DexamethasoneThe patients in Group D (Group Dexamethasone) will be given intravenous (iv) dexamethasone (0.5 mg.kg-1). |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) Class I-II,
- Between the ages of 7-18,
- Patients with written informed consent from themselves and their parents
Key exclusion criteria (8 listed)
- Allergic to study drugs,
- Taking antiemetic drugs 24 hours before the operation,
- Gastroesophageal reflux disease,
- Body mass index (BMI) >35 kg/m 2,
- In the period of menstruation,
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 |
|---|---|---|
| Ondansetron+DexamethasoneThe patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg) The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). The patients In Group D (Group Dexamethasone) will be given iv only dexamethasone (0.5 mg.kg-1) | Drug | Group OD (Group ondansetron+dexamethasone) |
| Palonosetron+DexamethasoneThe patients in Group OD (Group ondansetron+dexamethasone) will be given intravenous (iv) ondansetron (0.1 mg.kg-1) + dexamethasone (0.5 mg.kg) The patients in Group PD (Group palonosetron+dexamethasone) will be given intravenous (iv) palonosetron (0.75µg.kg-1) + dexamethasone (0.5 mg.kg-1). The patients In Group D (Group Dexamethasone) will be given iv only dexamethasone (0.5 mg.kg-1) | Drug | Group PD (Group palonosetron+dexamethasone) |
| DexamethasoneDexamethasone | Drug | Group D (Group Dexamethasone) |
Primary outcome
Incidence of palonosetron, ondansetron and dexamethasone in postoperative nausea and vomiting
Time frame: 72 hours
The primary endpoint of this study was to find the incidence of PONV among the three groups.
3 secondary outcomes
The time to first rescue antiemetic intake
Time frame: 72 hours
The total amount of antiemetic use
Time frame: 72 hours
The complications
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
Related trials for Laparoscopic Surgery
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron+Dexamethasone, Palonosetron+Dexamethasone and Dexamethasone in people with Laparoscopic Surgery and Pediatrics, run by Selcuk 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 3 inclusion and 8 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 30 Jun 2022. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Incidence of palonosetron, ondansetron and dexamethasone in postoperative nausea and vomiting (time frame: 72 hours). 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 30 Jun 2022.