Postoperative Nausea and VomitingPhase 4NCT02541019
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy
A Phase 4 study testing Ondansetron and Palonosetron in people with Postoperative Nausea and Vomiting, run by Hospital Federal de Bonsucesso at 1 site in Brazil.
Trial summary
Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the main characterized prophylactic agents in patients at high risk, however there are few studies comparing the efficacy of these drugs and no… Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ondansetron and Palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to 1 Jul 2017
- 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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Will be selected patients aged over 60 years, ASA 1-3 that are candidates for laparoscopic cholecystectomy
Who cannot join
- Participation in another study last month.
- Body mass index> 35.
- The occurrence of episodes of nausea or vomiting in the last 24 h prior to surgery.
- Use of corticosteroids.
- Smoking.
- Alcoholism.
Show all 10Show fewer
- Use of psychoactive drugs or any other drug with antiemetic effect.
- Known hypersensitivity to any study medication
- Severe diseases in organs such as kidney, liver, lung, heart, brain and bone marrow.
- Conversion laparoscopic cholecystectomy for conventional cholecystectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the main characterized prophylactic agents in patients at high risk, however there are few studies comparing the efficacy of these drugs and no study that addresses women aged over 60 years.
In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis of PONV.
Read the detailed description
Clinical, prospective, randomized double-blind trial will be conducted at the Federal Hospital Bonsucesso (HFB), Rio de Janeiro, Brazil. Eighty female patients, olther than 60 years, ASA I to III, undergoing laparoscopic cholecystectomy will be studied. They will be randomized into two groups of 40. One group will receive Palonosetron 75 mcg (Group P) and the other will receive Ondansetron 4mg (Group O). Patients will not receive premedication. Will be monitored in the operating room with non-invasive blood pressure, cardioscopy, pulse oximetry, capnography and bispectral index (BIS). After cannulation of peripheral vein, 10 ml of blood will be collected for further analysis. They will be given one minute before induction of anesthesia, intravenous (IV) bolus preparations of the studied antiemetics. Patients will be pre-oxygenated with oxygen at 100% for 5 minutes and the anesthetic induction is performed with intravenous administration of fentanyl 3 mcg / kg; Lidocaine 1.5 mg / kg and propofol 2 mg / kg. Tracheal intubation will be facilitated after 3 minutes of administration of Rocuronium 0.6 mg / kg EV .Maintenance of anesthesia will be with Sevoflurane 2 L / min in 50% oxygen / air, with its concentration adjusted to maintain BIS between 40-60. Remifentanil 0.05 mcg / kg / min to 0.2 mcg / kg / min IV can be administered intraoperatively if the heart rate or blood pressure to rise more than 20% of values baseline. Additional doses of rocuronium may also be administered as needed. Patients will receive paracoxibe 40 mg,dipirone 50 mg / kg and 50 mg of ranitidine IV after tracheal intubation and have the surgical wound infiltration with 20 mL of ropivacaine 0.5%, before the sutures. Neuromuscular blockade reversed with neostigmine 0.04 mg / kg and atropine 0.02 mg / kg IV at the end of surgery. Will be limited to insufflation of the pneumoperitoneum to abdominal pressure of 15 mmHg.
A non-participating physician will be aware of the research on which antiemetic was given and be responsible for postoperative prescription of patients. The researchers did not have access to prescription and medical records within 48 hours after surgery. Both groups will recive metoclopramide 10 mg (EV) as rescue medication for PONV, and the Group O will continue with prescription ondansetron 4 mg (EV) regular 8 / 8h, in the following 48 h after surgery. Patients will receive clinical visit by the research team 2, 6, 24 and 48 h after the end of surgery and will be questioned about the frequency and intensity of PONV, as well as other side effects. Finished the last evaluation, researchers will review the prescription and will note the use of opioids (type, dose, route of administration), use of rescue medication, total cost of antiemetic therapy (including 5HT3 antagonist and rescue medication), based on "Brasíndice" table.
All patients have their blood samples analyzed in the clinical research laboratory of the Universidade Federal Fluminense, for concurrent research of prevalence of polymorphisms of 5HT3 receptors and their correlation with the antiemetic effect. DNA will be extracted from blood samples using a kit to genomic DNA purification. Polymerase chain reaction test for real time will be applied below for analysis of single nucleotide polymorphisms of. The reactions are prepared with Genotyping according to the manufacturer's instructions and performed on a sequence detection system using standard thermal cycling conditions.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Ondansetron, Palonosetron
- Keywords
- C23.888.821.712.700
- 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.
OndansetronDrug
4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery.
PalonosetronDrug
75 mcg IV, one minute before the anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron | Experimental | Palonosetron (iv) one minute before anesthesic induction. Receives: Drug: Palonosetron |
| Ondansetron | Experimental | ondansetron (iv) one minute before anesthesic induction and ondansetron regular three times a day for two days after the surgery. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and intensity of individual episodes of PONV.
Measured: 48 h after surgery
Secondary outcomes (7)
Intensity of nausea
Evaluate nausea intensity in numeric scale (0-10) during clinical visit
Measured: during clinical visit 2, 6, 24 and 48 h postoperatively
Need of medication for antiemetic rescue
Assess the need of medication for antiemetic rescue during the 48 h after surgery
Measured: during the 48 h after surgery
Number of complete responders to medication
Determine the number of complete responders to medications (no emetic episode or rescue medication during the 48 hours after surgery)
Measured: during the 48 h after surgery
Degree of satisfaction with antiemetic therapy
Know the degree of satisfaction with antiemetic therapy, through the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very satisfied)
Measured: during the 48 h after surgery
Cost of antiemetic medication
total cost of antiemetic therapy (including 5HT3 antagonist and rescue medication), based on the table "Brasíndice".
Measured: during the 48 h after surgery
Frequency and intensity of adverse effects
Determine the frequency and intensity of adverse effects by means of numerical scale(0-10) (headache, dizziness, drowsiness and others)
Measured: during the 48 h after surgery
Frequency of polymorphism of 5HT3a receptors and 5HT3b
To assess the frequency of polymorphism and 5HT3b 5HT3a receptors and their correlation with the frequency and intensity of antiemetic effect and adverse effects.
Measured: participants will be followed for the duration of hospital stay, an expected average of 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startOct 2015
- Primary completion1 Jan 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Federal de Bonsucesso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estevão Braga, Hospital Federal de Bonsucesso
- Investigators
- Ismar L Cavalcanti, PhD, Principal investigator, UFF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541019
- Sponsor's protocol ID
- 48149215.0.0000.5253
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Horn CC, Wallisch WJ, Homanics GE, Williams JP. Pathophysiological and neurochemical mechanisms of postoperative nausea and vomiting. Eur J Pharmacol. 2014 Jan 5;722:55-66. doi: 10.1016/j.ejphar.2013.10.037. Epub 2013 Oct 26.
PubMed 24495419Silva AC, O'Ryan F, Poor DB. Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review. J Oral Maxillofac Surg. 2006 Sep;64(9):1385-97. doi: 10.1016/j.joms.2006.05.024.
PubMed 16916674Grover VK, Mathew PJ, Hegde H. Efficacy of orally disintegrating ondansetron in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomised, double-blind placebo controlled study. Anaesthesia. 2009 Jun;64(6):595-600. doi: 10.1111/j.1365-2044.2008.05860.x.
PubMed 19453311Turkistani A, Abdullah K, Manaa E, Delvi B, Khairy G, Abdulghani B, Khalil N, Damas F, El-Dawlatly A. Effect of fluid preloading on postoperative nausea and vomiting following laparoscopic cholecystectomy. Saudi J Anaesth. 2009 Jul;3(2):48-52. doi: 10.4103/1658-354X.57872.
PubMed 20532102Oksuz H, Zencirci B, Ezberci M. Comparison of the effectiveness of metoclopramide, ondansetron, and granisetron on the prevention of nausea and vomiting after laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2007 Dec;17(6):803-8. doi: 10.1089/lap.2006.0243.
PubMed 18158814Rusch D, Eberhart LH, Wallenborn J, Kranke P. Nausea and vomiting after surgery under general anesthesia: an evidence-based review concerning risk assessment, prevention, and treatment. Dtsch Arztebl Int. 2010 Oct;107(42):733-41. doi: 10.3238/arztebl.2010.0733. Epub 2010 Oct 22.
PubMed 21079721Rueffert H, Thieme V, Wallenborn J, Lemnitz N, Bergmann A, Rudlof K, Wehner M, Olthoff D, Kaisers UX. Do variations in the 5-HT3A and 5-HT3B serotonin receptor genes (HTR3A and HTR3B) influence the occurrence of postoperative vomiting? Anesth Analg. 2009 Nov;109(5):1442-7. doi: 10.1213/ane.0b013e3181b2359b. Epub 2009 Aug 27.
PubMed 19713259Janicki PK, Sugino S. Genetic factors associated with pharmacotherapy and background sensitivity to postoperative and chemotherapy-induced nausea and vomiting. Exp Brain Res. 2014 Aug;232(8):2613-25. doi: 10.1007/s00221-014-3968-z. Epub 2014 May 4.
PubMed 24792505Trammel M, Roederer M, Patel J, McLeod H. Does pharmacogenomics account for variability in control of acute chemotherapy-induced nausea and vomiting with 5-hydroxytryptamine type 3 receptor antagonists? Curr Oncol Rep. 2013 Jun;15(3):276-85. doi: 10.1007/s11912-013-0312-x.
PubMed 23512709Choi YS, Shim JK, Yoon DH, Jeon DH, Lee JY, Kwak YL. Effect of ramosetron on patient-controlled analgesia related nausea and vomiting after spine surgery in highly susceptible patients: comparison with ondansetron. Spine (Phila Pa 1976). 2008 Aug 1;33(17):E602-6. doi: 10.1097/BRS.0b013e31817c6bde.
PubMed 18670328Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin. 2003 Fall;41(4):13-32. doi: 10.1097/00004311-200341040-00004. No abstract available.
PubMed 14574212Ribeiro AHS, Braga ELC, Ferreira NAG, Olej B, Vercosa N, Antunes LDS, Cavalcanti IL. CYP2D6 isoenzyme and ABCB1 gene polymorphisms associated with postoperative nausea and vomiting in women undergoing laparoscopic cholecystectomy: a randomized trial. Braz J Anesthesiol. 2024 May-Jun;74(3):744423. doi: 10.1016/j.bjane.2023.02.002. Epub 2023 Feb 23.
PubMed 36841429
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02541019
- Acronym / sponsor ID
- 48149215.0.0000.5253
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- C23.888.821.712.700
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Federal de BonsucessoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 4 Sep 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.
Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the main characterized prophylactic agents in patients at high risk, however there are few studies comparing the efficacy of these drugs and no study that addresses women aged over 60 years.
In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis of PONV.
Detailed description
Clinical, prospective, randomized double-blind trial will be conducted at the Federal Hospital Bonsucesso (HFB), Rio de Janeiro, Brazil. Eighty female patients, olther than 60 years, ASA I to III, undergoing laparoscopic cholecystectomy will be studied. They will be randomized into two groups of 40. One group will receive Palonosetron 75 mcg (Group P) and the other will receive Ondansetron 4mg (Group O). Patients will not receive premedication. Will be monitored in the operating room with non-invasive blood pressure, cardioscopy, pulse oximetry, capnography and bispectral index (BIS). After cannulation of peripheral vein, 10 ml of blood will be collected for further analysis. They will be given one minute before induction of anesthesia, intravenous (IV) bolus preparations of the studied antiemetics. Patients will be pre-oxygenated with oxygen at 100% for 5 minutes and the anesthetic induction is performed with intravenous administration of fentanyl 3 mcg / kg; Lidocaine 1.5 mg / kg and propofol 2 mg / kg. Tracheal intubation will be facilitated after 3 minutes of administration of Rocuronium 0.6 mg / kg EV .Maintenance of anesthesia will be with Sevoflurane 2 L / min in 50% oxygen / air, with its concentration adjusted to maintain BIS between 40-60. Remifentanil 0.05 mcg / kg / min to 0.2 mcg / kg / min IV can be administered intraoperatively if the heart rate or blood pressure to rise more than 20% of values baseline. Additional doses of rocuronium may also be administered as needed. Patients will receive paracoxibe 40 mg,dipirone 50 mg / kg and 50 mg of ranitidine IV after tracheal intubation and have the surgical wound infiltration with 20 mL of ropivacaine 0.5%, before the sutures. Neuromuscular blockade reversed with neostigmine 0.04 mg / kg and atropine 0.02 mg / kg IV at the end of surgery. Will be limited to insufflation of the pneumoperitoneum to abdominal pressure of 15 mmHg.
A non-participating physician will be aware of the research on which antiemetic was given and be responsible for postoperative prescription of patients. The researchers did not have access to prescription and medical records within 48 hours after surgery. Both groups will recive metoclopramide 10 mg (EV) as rescue medication for PONV, and the Group O will continue with prescription ondansetron 4 mg (EV) regular 8 / 8h, in the following 48 h after surgery. Patients will receive clinical visit by the research team 2, 6, 24 and 48 h after the end of surgery and will be questioned about the frequency and intensity of PONV, as well as other side effects. Finished the last evaluation, researchers will review the prescription and will note the use of opioids (type, dose, route of administration), use of rescue medication, total cost of antiemetic therapy (including 5HT3 antagonist and rescue medication), based on "Brasíndice" table.
All patients have their blood samples analyzed in the clinical research laboratory of the Universidade Federal Fluminense, for concurrent research of prevalence of polymorphisms of 5HT3 receptors and their correlation with the antiemetic effect. DNA will be extracted from blood samples using a kit to genomic DNA purification. Polymerase chain reaction test for real time will be applied below for analysis of single nucleotide polymorphisms of. The reactions are prepared with Genotyping according to the manufacturer's instructions and performed on a sequence detection system using standard thermal cycling conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palonosetron | Experimental | Drug: PalonosetronPalonosetron (iv) one minute before anesthesic induction. |
| Ondansetron | Experimental | Drug: Ondansetronondansetron (iv) one minute before anesthesic induction and ondansetron regular three times a day for two days after the surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Will be selected patients aged over 60 years, ASA 1-3 that are candidates for laparoscopic cholecystectomy
Key exclusion criteria (10 listed)
- Participation in another study last month.
- Body mass index> 35.
- The occurrence of episodes of nausea or vomiting in the last 24 h prior to surgery.
- Use of corticosteroids.
- Smoking.
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 |
|---|---|---|
| Ondansetron4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery. | Drug | Ondansetron |
| Palonosetron75 mcg IV, one minute before the anesthesia induction. | Drug | Palonosetron |
Primary outcome
Frequency and intensity of individual episodes of PONV.
Time frame: 48 h after surgery
7 secondary outcomes
Intensity of nausea
Time frame: during clinical visit 2, 6, 24 and 48 h postoperatively
Need of medication for antiemetic rescue
Time frame: during the 48 h after surgery
Number of complete responders to medication
Time frame: during the 48 h after surgery
Degree of satisfaction with antiemetic therapy
Time frame: during the 48 h after surgery
Cost of antiemetic medication
Time frame: during the 48 h after surgery
Frequency and intensity of adverse effects
Time frame: during the 48 h after surgery
Frequency of polymorphism of 5HT3a receptors and 5HT3b
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 h
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 9 Aug 2017.
- Results publication: PubMed 24495419Horn CC, Wallisch WJ, Homanics GE, Williams JP. Pathophysiological and neurochemical mechanisms of postoperative nausea and vomiting. Eur J Pharmacol. 2014 Jan 5;722:55-66. doi: 10.1016/j.ejphar.2013.10.037. Epub 2013 Oct 26.
- Results publication: PubMed 16916674Silva AC, O'Ryan F, Poor DB. Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review. J Oral Maxillofac Surg. 2006 Sep;64(9):1385-97. doi: 10.1016/j.joms.2006.05.024.
- Results publication: PubMed 19453311Grover VK, Mathew PJ, Hegde H. Efficacy of orally disintegrating ondansetron in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomised, double-blind placebo controlled study. Anaesthesia. 2009 Jun;64(6):595-600. doi: 10.1111/j.1365-2044.2008.05860.x.
- Results publication: PubMed 20532102Turkistani A, Abdullah K, Manaa E, Delvi B, Khairy G, Abdulghani B, Khalil N, Damas F, El-Dawlatly A. Effect of fluid preloading on postoperative nausea and vomiting following laparoscopic cholecystectomy. Saudi J Anaesth. 2009 Jul;3(2):48-52. doi: 10.4103/1658-354X.57872.
- Results publication: PubMed 18158814Oksuz H, Zencirci B, Ezberci M. Comparison of the effectiveness of metoclopramide, ondansetron, and granisetron on the prevention of nausea and vomiting after laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2007 Dec;17(6):803-8. doi: 10.1089/lap.2006.0243.
- Results publication: PubMed 21079721Rusch D, Eberhart LH, Wallenborn J, Kranke P. Nausea and vomiting after surgery under general anesthesia: an evidence-based review concerning risk assessment, prevention, and treatment. Dtsch Arztebl Int. 2010 Oct;107(42):733-41. doi: 10.3238/arztebl.2010.0733. Epub 2010 Oct 22.
- Results publication: PubMed 19713259Rueffert H, Thieme V, Wallenborn J, Lemnitz N, Bergmann A, Rudlof K, Wehner M, Olthoff D, Kaisers UX. Do variations in the 5-HT3A and 5-HT3B serotonin receptor genes (HTR3A and HTR3B) influence the occurrence of postoperative vomiting? Anesth Analg. 2009 Nov;109(5):1442-7. doi: 10.1213/ane.0b013e3181b2359b. Epub 2009 Aug 27.
- Results publication: PubMed 24792505Janicki PK, Sugino S. Genetic factors associated with pharmacotherapy and background sensitivity to postoperative and chemotherapy-induced nausea and vomiting. Exp Brain Res. 2014 Aug;232(8):2613-25. doi: 10.1007/s00221-014-3968-z. Epub 2014 May 4.
- Results publication: PubMed 23512709Trammel M, Roederer M, Patel J, McLeod H. Does pharmacogenomics account for variability in control of acute chemotherapy-induced nausea and vomiting with 5-hydroxytryptamine type 3 receptor antagonists? Curr Oncol Rep. 2013 Jun;15(3):276-85. doi: 10.1007/s11912-013-0312-x.
- Results publication: PubMed 18670328Choi YS, Shim JK, Yoon DH, Jeon DH, Lee JY, Kwak YL. Effect of ramosetron on patient-controlled analgesia related nausea and vomiting after spine surgery in highly susceptible patients: comparison with ondansetron. Spine (Phila Pa 1976). 2008 Aug 1;33(17):E602-6. doi: 10.1097/BRS.0b013e31817c6bde.
- Results publication: PubMed 14574212Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin. 2003 Fall;41(4):13-32. doi: 10.1097/00004311-200341040-00004. No abstract available.
- Derived from this study: PubMed 36841429Ribeiro AHS, Braga ELC, Ferreira NAG, Olej B, Vercosa N, Antunes LDS, Cavalcanti IL. CYP2D6 isoenzyme and ABCB1 gene polymorphisms associated with postoperative nausea and vomiting in women undergoing laparoscopic cholecystectomy: a randomized trial. Braz J Anesthesiol. 2024 May-Jun;74(3):744423. doi: 10.1016/j.bjane.2023.02.002. Epub 2023 Feb 23.
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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.
Ismar L Cavalcanti, PhD principal investigator
UFF
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 Ondansetron and Palonosetron in people with Postoperative Nausea and Vomiting, run by Hospital Federal de Bonsucesso at 1 site in Brazil.
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 10 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 9 Aug 2017. 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 Brazil. 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?
Frequency and intensity of individual episodes of PONV. (time frame: 48 h after surgery). 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 NCT02541019, which also lists 12 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 9 Aug 2017.