AntiemeticPhase 4NCT04576390
Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing ERCP
A Phase 4 study testing Ondansetron 4 mg and Palonosetron 75 mcg in people with Antiemetic and Postoperative Nausea and Vomiting, run by Theodor Bilharz Research Institute.
Trial summary
This study is designed to compare the effects of a single dose Ondansetron 4mg versus Palonosetron 75mcg in the prophylaxis against early \& delayed postoperative nausea and vomiting in the first 48 hours post-operatively in patients undergoing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to determine the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Antiemetic, Postoperative Nausea and Vomiting
- What is being tested?
- Ondansetron 4 mg and Palonosetron 75 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2020to 25 May 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
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-60 years of age
- American Society of Anaesthesiologists physical status (ASA) grade I-II
- 1 - 2 Risk factor for PONV according to Apfel Score
- o Apfel Score includes 4 points : Female gender, history of PONV and/or motion sickness, non-smoking status, and post-operative use of opioids , the risk of PONV is 10%, 20%, 40%,60% or 80% respectively
- Undergoing elective ERCP.
- Having provided written informed consent signed by patient or guardian.
Who cannot join
- Allergy to any drug being used in the study
- ASA III-IV
- History of vomiting, retching, nausea or antiemetics use in the 24 hours prior to day of procedure
- Patients receiving steroids, prokinetics, or antacids intake in the previous 48 hours
- Patients with significant gastro-oesophageal disease
- Menstruating, lactating or pregnant females
- History of alcohol or substance abuse
- Significant systemic disease of the liver, kidneys, heart, lungs, Cancer and or diabetes mellitus.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography ERCP: A Prospective Randomized Controlled Study
This study is designed to compare the effects of a single dose Ondansetron 4mg versus Palonosetron 75mcg in the prophylaxis against early \& delayed postoperative nausea and vomiting in the first 48 hours post-operatively in patients undergoing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to determine the complete response, complete control and failure rates.
Read the detailed description
Premedication will be omitted. Pre-operative baseline values of heart rate and blood pressure will be recorded. On arrival in the operation theatre, the routine monitoring devices (ECG, Pulse Oximetry \& Non Invasive Blood Pressure) will be applied and base line heart rate, blood pressure (Systolic, diastolic and mean arterial blood pressure) and arterial Oxygen saturation will be recorded.
After an intravenous line is secured, while pre-oxygenating the patient. Anaesthesia will be induced using fentanyl 1-2 µg/kg and sodium propofol 1.5-2.5 mg/kg according to the patient general condition and hemodynamics and intubation will be facilitated by using atracurium besylate 0.5mg/kg.
Anaesthesia will be maintained with O2 in air (50%), sevoflurane (0.8-1.0 MAC). Muscle relaxation will be maintained with boluses of atracurium besylate 0.1 mg/kg. Intermittent positive pressure ventilation will be adjusted to maintain end tidal carbon dioxide between 30-35mm Hg. Intravenous crystalloids (3-4 ml/kg/hr) will infused during intra-operative and immediate post-operative period. Intra-operatively, the following parameters will be monitored: ECG, blood pressure, pulse rate, end tidal carbon dioxide (ET CO2) \& oxygen saturation (SpO2). Diclofenac sodium 1mg/kg intramuscularly to protect against Post ERCP Pancreatitis \& Paracetamol (1gm) intravenously will be administered 15 minutes before the end of procedure followed by the administration of the anti-emetic prophylaxis according to group allocation.
At the end, residual neuromuscular block will be antagonized using atropine and neostigmine and trachea will be extubated after signs of adequate neuro-muscular reversal are achieved. After extubation, patients will be transferred to the Post anaesthesia care unit where the blood pressure, heart rate, respiratory rate and O2 saturation will be monitored continuously every five minutes for 60 minutes.
If Visual Analogue Score (VAS) score is ≥3, rescue analgesia will be provided with Pethidine in 10mg increments / 5minutes until the VAS score is less than 3.
Pain intensity will be assessed using VAS for the first 24 hours. Post-operative pain relief will be provided Paracetamol (1gm) intravenously given regularly every 8 hours for the first 24 hours.
Any incidence of nausea, retching or vomiting and use of any rescue medication during the first 24 hours at time interval of 0, 1/2, 1, 2, 6,12, 24 and 48 h will be noted, Nausea is defined as the subjective sensation of an urge to vomit, in the absence of expulsive muscular movements. Retching is defined as an unproductive effort to vomit. Vomiting is defined as the forcible expulsion of the gastric contents through the mouth. Retching and vomiting will be collectively termed emetic episodes.
Rescue anti-emetic therapy in the form of Metoclopramide 10 mg intravenously will be provided for any patient suffering from an emetic episode as described above. The use of antiemetic rescue medication will be recorded \& analysed.
Patients will stay at the hospital post ERCP according to the discretion of the treating physician opinion, if any patient will be discharged before 48 hours, the data will be collected by telephone.
- Conditions
- Antiemetic, Postoperative Nausea and Vomiting
- Being tested
- Ondansetron 4 mg, Palonosetron 75 mcg
- Keywords
- Palonosetron, Ondansetron, PONV, ERCP
- 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 4 mgDrug
Also called Zofran
Antiemetic drug
Palonosetron 75 mcgDrug
Also called Aloxi
Antiemetic drug
| Study group | Role | What they receive |
|---|---|---|
| Group O | Active comparator | On the day of procedure, the recruited patients in Group O will be given Ondansetron 4 mg diluted for up to 5ml using normal saline by a colleague not participating to the study or the patient care \& will label the syringes as antiemetic. Receives: Drug: Ondansetron 4 mg |
| Group P | Active comparator | On the day of procedure, the recruited patients in Group P will be given Palonosetron 75 mcg diluted for up to 5ml using normal saline by a colleague not participating to the study or the patient care \& will label the syringes as antiemetic. Receives: Drug: Palonosetron 75 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV
Incidence of nausea, retching or vomiting
Measured: During 24 hours post-operatively
Secondary outcomes (5)
Incidence of PONV
Incidence of nausea, retching or vomiting
Measured: During 48 hours post-operatively
Complete Responders
Number of patients has no rescue medication and no emesis
Measured: During 48 hours postoperatively
Complete control
Number of patients has no rescue medication, no emesis, no more than mild nausea
Measured: During 48 hours postoperatively
Failed prophylaxis
Number of patients with episode of emesis and needs rescue medication
Measured: During 48 hours postoperatively
Time to rescue anti-emetics or emesis
Time until patient takes antiemetic or emesis occurs
Measured: Time in minutes during 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start24 Oct 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion25 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntiemeticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Hanan Farouk Khafagy, Theodor Bilharz Research Institute
- Investigators
- Omar M. Abou-Hashim, residant, Study chair, Theodor Bilharz Research InstituteYahia M. Hammad, Lecteurer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576390
- Sponsor's protocol ID
- TBRI -Palonosetron
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography ERCP: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04576390
- Acronym / sponsor ID
- TBRI -Palonosetron
- Conditions
- Antiemetic, Postoperative Nausea and Vomiting
- Keywords
- Palonosetron, Ondansetron, PONV, ERCP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 24 Oct 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 25 May 2021 (estimated)
- First posted
- 6 Oct 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.
This study is designed to compare the effects of a single dose Ondansetron 4mg versus Palonosetron 75mcg in the prophylaxis against early \& delayed postoperative nausea and vomiting in the first 48 hours post-operatively in patients undergoing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to determine the complete response, complete control and failure rates.
Detailed description
Premedication will be omitted. Pre-operative baseline values of heart rate and blood pressure will be recorded. On arrival in the operation theatre, the routine monitoring devices (ECG, Pulse Oximetry \& Non Invasive Blood Pressure) will be applied and base line heart rate, blood pressure (Systolic, diastolic and mean arterial blood pressure) and arterial Oxygen saturation will be recorded.
After an intravenous line is secured, while pre-oxygenating the patient. Anaesthesia will be induced using fentanyl 1-2 µg/kg and sodium propofol 1.5-2.5 mg/kg according to the patient general condition and hemodynamics and intubation will be facilitated by using atracurium besylate 0.5mg/kg.
Anaesthesia will be maintained with O2 in air (50%), sevoflurane (0.8-1.0 MAC). Muscle relaxation will be maintained with boluses of atracurium besylate 0.1 mg/kg. Intermittent positive pressure ventilation will be adjusted to maintain end tidal carbon dioxide between 30-35mm Hg. Intravenous crystalloids (3-4 ml/kg/hr) will infused during intra-operative and immediate post-operative period. Intra-operatively, the following parameters will be monitored: ECG, blood pressure, pulse rate, end tidal carbon dioxide (ET CO2) \& oxygen saturation (SpO2). Diclofenac sodium 1mg/kg intramuscularly to protect against Post ERCP Pancreatitis \& Paracetamol (1gm) intravenously will be administered 15 minutes before the end of procedure followed by the administration of the anti-emetic prophylaxis according to group allocation.
At the end, residual neuromuscular block will be antagonized using atropine and neostigmine and trachea will be extubated after signs of adequate neuro-muscular reversal are achieved. After extubation, patients will be transferred to the Post anaesthesia care unit where the blood pressure, heart rate, respiratory rate and O2 saturation will be monitored continuously every five minutes for 60 minutes.
If Visual Analogue Score (VAS) score is ≥3, rescue analgesia will be provided with Pethidine in 10mg increments / 5minutes until the VAS score is less than 3.
Pain intensity will be assessed using VAS for the first 24 hours. Post-operative pain relief will be provided Paracetamol (1gm) intravenously given regularly every 8 hours for the first 24 hours.
Any incidence of nausea, retching or vomiting and use of any rescue medication during the first 24 hours at time interval of 0, 1/2, 1, 2, 6,12, 24 and 48 h will be noted, Nausea is defined as the subjective sensation of an urge to vomit, in the absence of expulsive muscular movements. Retching is defined as an unproductive effort to vomit. Vomiting is defined as the forcible expulsion of the gastric contents through the mouth. Retching and vomiting will be collectively termed emetic episodes.
Rescue anti-emetic therapy in the form of Metoclopramide 10 mg intravenously will be provided for any patient suffering from an emetic episode as described above. The use of antiemetic rescue medication will be recorded \& analysed.
Patients will stay at the hospital post ERCP according to the discretion of the treating physician opinion, if any patient will be discharged before 48 hours, the data will be collected by telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group O | Active comparator | Drug: Ondansetron 4 mgOn the day of procedure, the recruited patients in Group O will be given Ondansetron 4 mg diluted for up to 5ml using normal saline by a colleague not participating to the study or the patient care \& will label the syringes as antiemetic. |
| Group P | Active comparator | Drug: Palonosetron 75 mcgOn the day of procedure, the recruited patients in Group P will be given Palonosetron 75 mcg diluted for up to 5ml using normal saline by a colleague not participating to the study or the patient care \& will label the syringes as antiemetic. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18-60 years of age
- American Society of Anaesthesiologists physical status (ASA) grade I-II
- 1 - 2 Risk factor for PONV according to Apfel Score
- o Apfel Score includes 4 points : Female gender, history of PONV and/or motion sickness, non-smoking status, and post-operative use of opioids , the risk of PONV is 10%, 20%, 40%,60% or 80% respectively
- Undergoing elective ERCP.
Key exclusion criteria (8 listed)
- Allergy to any drug being used in the study
- ASA III-IV
- History of vomiting, retching, nausea or antiemetics use in the 24 hours prior to day of procedure
- Patients receiving steroids, prokinetics, or antacids intake in the previous 48 hours
- Patients with significant gastro-oesophageal disease
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 4 mgAlso: ZofranAntiemetic drug | Drug | Group O |
| Palonosetron 75 mcgAlso: AloxiAntiemetic drug | Drug | Group P |
Primary outcome
Incidence of PONV
Time frame: During 24 hours post-operatively
Incidence of nausea, retching or vomiting
5 secondary outcomes
Incidence of PONV
Time frame: During 48 hours post-operatively
Complete Responders
Time frame: During 48 hours postoperatively
Complete control
Time frame: During 48 hours postoperatively
Failed prophylaxis
Time frame: During 48 hours postoperatively
Time to rescue anti-emetics or emesis
Time frame: Time in minutes during 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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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.
Omar M. Abou-Hashim, residant study chair
Theodor Bilharz Research Institute
Yahia M. Hammad, Lecteurer study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron 4 mg and Palonosetron 75 mcg in people with Antiemetic and Postoperative Nausea and Vomiting, run by Theodor Bilharz Research Institute.
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 6 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mounis A. Sedira, Prof. (00201110081661, mounis200@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PONV (time frame: During 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 6 Oct 2020.