Nausea, PostoperativeNCT04533867
Palonosetron vs. Ondansetron for Postoperative Nausea and Vomiting in Bariatric Surgery
An observational study of Nausea, Postoperative and Vomiting, Postoperative, run by Bagcilar Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nausea, Postoperative, Vomiting, Postoperative, Patient Reported Outcomes
- What is being tested?
- Laparoscopic sleeve gastrectomy, Palonosetron 1mcg/kg and Ondansetron 1 mg/kg, max dose 8 mg
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Aug 2020to 1 Jan 2021
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: obese patients underwent laparoscopic sleeve gastrectomy
Who may be able to join
- All morbidity obese patients underwent laparoscopic sleeve gastrectomy
Who cannot join
- drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bagcılar Training and Research Hospital
Istanbul
Surp Pırgic Armenian Hospital
Istanbul
About this study
Official title: Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.
Read the detailed description
Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.
- Conditions
- Nausea, Postoperative, Vomiting, Postoperative, Patient Reported Outcomes, Pain, Postoperative, Antiemetics
- Being tested
- Laparoscopic sleeve gastrectomy, Palonosetron 1mcg/kg, Ondansetron 1 mg/kg, max dose 8 mg
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape
Palonosetron 1mcg/kgDrug
Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.
Ondansetron 1 mg/kg, max dose 8 mgDrug
Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | In Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once. Receives: Procedure: Laparoscopic sleeve gastrectomy; Drug: Ondansetron 1 mg/kg, max dose 8 mg | |
| Palonosetron | The antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once. Receives: Procedure: Laparoscopic sleeve gastrectomy; Drug: Palonosetron 1mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nause and vomiting 6hr
Visual Analog Scale score for nausea and vomiting
Measured: postoperative 6 hours
Nause and vomiting 24hr
Visual Analog Scale score for nausea and vomiting
Measured: postoperative 24 hours
Nause and vomiting 48hr
Visual Analog Scale score for nausea and vomiting
Measured: postoperative 48 hours
Nause and vomiting 72hr
Visual Analog Scale score for nausea and vomiting
Measured: postoperative 72 hours
amount of rescue anti-emetic drugs
Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week.
Measured: postoperative seventh day
Secondary outcomes (4)
Pain 6hr
Visual Analog Scale score for pain
Measured: postoperative 6 hours
Pain 24hr
Visual Analog Scale score for pain
Measured: postoperative 24 hours
Pain 48hr
Visual Analog Scale score for pain
Measured: postoperative 48 hours
Pain 72hr
Visual Analog Scale score for pain
Measured: postoperative 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start15 Aug 2020
- Primary completion15 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nausea, PostoperativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nadir Adnan Hacım, Bagcilar Training and Research Hospital
- Investigators
- Ali Solmaz, Ass. Prof., Study director, Private Camlıca Erdem Hospital/Istanbul-TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533867
- Sponsor's protocol ID
- Beren Hacım 3
- Status last verified
- Jan 2021
- First submitted
- 9 Aug 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aydin A, Kacmaz M, Boyaci A. Comparison of ondansetron, tropisetron, and palonosetron for the prevention of postoperative nausea and vomiting after middle ear surgery. Curr Ther Res Clin Exp. 2019 Jun 22;91:17-21. doi: 10.1016/j.curtheres.2019.06.002. eCollection 2019.
PubMed 31384338Lee S, Kim I, Pyeon T, Lee S, Song J, Rhee J, Jeong S. Population pharmacokinetics of palonosetron and model-based assessment of dosing strategies. J Anesth. 2019 Jun;33(3):381-389. doi: 10.1007/s00540-019-02641-5. Epub 2019 Apr 11.
PubMed 30976908Rajnikant K, Bhukal I, Kaloria N, Soni SL, Kajal K. Comparison of Palonosetron and Dexamethasone with Ondansetron and Dexamethasone to Prevent Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy. Anesth Essays Res. 2019 Apr-Jun;13(2):317-322. doi: 10.4103/aer.AER_21_19.
PubMed 31198253
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04533867
- Acronym / sponsor ID
- Beren Hacım 3
- Conditions
- Nausea, Postoperative, Vomiting, Postoperative, Patient Reported Outcomes, Pain, Postoperative, Antiemetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 1 Sep 2020 (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.
Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.
Detailed description
Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | – | Procedure: Laparoscopic sleeve gastrectomy, Drug: Ondansetron 1 mg/kg, max dose 8 mgIn Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once. |
| Palonosetron | – | Procedure: Laparoscopic sleeve gastrectomy, Drug: Palonosetron 1mcg/kgThe antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- obese patients underwent laparoscopic sleeve gastrectomy
Key inclusion criteria (1 listed)
- All morbidity obese patients underwent laparoscopic sleeve gastrectomy
Key exclusion criteria (1 listed)
- drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.
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 |
|---|---|---|
| Laparoscopic sleeve gastrectomySleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape | Procedure or surgery | Ondansetron, Palonosetron |
| Palonosetron 1mcg/kgInjectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery. | Drug | Palonosetron |
| Ondansetron 1 mg/kg, max dose 8 mgInjectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery. | Drug | Ondansetron |
Primary outcome
Nause and vomiting 6hr
Time frame: postoperative 6 hours
Visual Analog Scale score for nausea and vomiting
Nause and vomiting 24hr
Time frame: postoperative 24 hours
Visual Analog Scale score for nausea and vomiting
Nause and vomiting 48hr
Time frame: postoperative 48 hours
Visual Analog Scale score for nausea and vomiting
Nause and vomiting 72hr
Time frame: postoperative 72 hours
Visual Analog Scale score for nausea and vomiting
amount of rescue anti-emetic drugs
Time frame: postoperative seventh day
Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week.
4 secondary outcomes
Pain 6hr
Time frame: postoperative 6 hours
Pain 24hr
Time frame: postoperative 24 hours
Pain 48hr
Time frame: postoperative 48 hours
Pain 72hr
Time frame: postoperative 72 hours
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 22 Jan 2021.
- Results publication: PubMed 31384338Aydin A, Kacmaz M, Boyaci A. Comparison of ondansetron, tropisetron, and palonosetron for the prevention of postoperative nausea and vomiting after middle ear surgery. Curr Ther Res Clin Exp. 2019 Jun 22;91:17-21. doi: 10.1016/j.curtheres.2019.06.002. eCollection 2019.
- Results publication: PubMed 30976908Lee S, Kim I, Pyeon T, Lee S, Song J, Rhee J, Jeong S. Population pharmacokinetics of palonosetron and model-based assessment of dosing strategies. J Anesth. 2019 Jun;33(3):381-389. doi: 10.1007/s00540-019-02641-5. Epub 2019 Apr 11.
- Results publication: PubMed 31198253Rajnikant K, Bhukal I, Kaloria N, Soni SL, Kajal K. Comparison of Palonosetron and Dexamethasone with Ondansetron and Dexamethasone to Prevent Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy. Anesth Essays Res. 2019 Apr-Jun;13(2):317-322. doi: 10.4103/aer.AER_21_19.
- Individual participant dataSharing planned: Undecided
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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.
Ali Solmaz, Ass. Prof. study director
Private Camlıca Erdem Hospital/Istanbul-TURKEY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea, Postoperative and Vomiting, Postoperative, run by Bagcilar Training and Research Hospital at 2 sites 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 1 inclusion and 1 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Nause and vomiting 6hr (time frame: postoperative 6 hours). The study lists 5 primary outcomes in all. 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 NCT04533867, which also lists 3 linked publications.
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 22 Jan 2021.