Cholecystectomy, LaparoscopicPhase 4NCT04745273
Interaction Between Tramadol and Ondansetron
A Phase 4 study testing Ondansetron 4 MG (Kemoset 4mg) and Salin solution in people with Cholecystectomy, Laparoscopic, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
In the postoperative period; pain, nausea, and vomiting are undesirable side effects that reduce the patient's comfort and may lead to various complications. Ondansetron is frequently used as an antiemetic and tramadol hydrochloride is used for postoperative analgesia in laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- Ondansetron 4 MG (Kemoset 4mg) and Salin solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2020to 25 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 patients over the age of 18, ASA I-II, undergoing laparoscopic cholecystectomy
Who cannot join
- Patients under 18 years of age
- Patients with known allergies to the drugs to be used
- Pregnant and breastfeeding mothers
- Patients who received antiemetic or cortisone within 24 hours before surgery
- Patients with mental illness or epilepsy
- Patients with alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Kozyatagi Hastanesi
Istanbul, (_34742__) ______
About this study
Official title: The Effect of Ondansetron on the Efficacy of Tramadol
In the postoperative period; pain, nausea, and vomiting are undesirable side effects that reduce the patient's comfort and may lead to various complications. Ondansetron is frequently used as an antiemetic and tramadol hydrochloride is used for postoperative analgesia in laparoscopic cholecystectomy. However, some studies have reported that there is a drug interaction between these two drugs and they reduce each other's effects, thus requiring more analgesics in the postoperative period.
The aim of this study is; To evaluate whether ondansetron reduces the analgesic efficacy of tramadol hydrochloride in laparoscopic cholecystectomies.
Read the detailed description
During the operation, 4 mg iv ondansetron (2mL) will be administered to the ondansetron group and 2mL iv 09% saline will be administered to the placebo group. The patients' heart rate, blood pressure, oxygen saturation, sedation score (with Ramsey Seading Score), amount of pain (with NRS), degree of nausea (with NRS), whether there is vomiting, whether analgesic or antiemetic treatment is required, and the amount of tramadol use will be recorded at 1, 2, 4, 8, 12 and 24 hours in the postoperative period.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Ondansetron 4 MG (Kemoset 4mg), Salin solution
- Keywords
- tramadol, ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4 MG (Kemoset 4mg)Drug
Also called Kemoset
Ondansetron 4mg (iv) will administer to participants
Salin solutionOther
Salin solution 2ml (iv) will administer to participants
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Active comparator | Participants will receive Kemoset 4 mg iv intraoperatively Receives: Drug: Ondansetron 4 MG (Kemoset 4mg) |
| Salin solution | Placebo comparator | Participants will receive Salin solution 2ml (iv) intraoperatively Receives: Other: Salin solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interaction
The hypothesis of this study is that if ondanstron is given together with tramadol peroperatively, tramadol consumption is increase postoperatively due to tramadol ondansetron interaction. The primary outcome measure is consumption of tramadol postoperatively for 24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start2 Sep 2020
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- More trials run by Acibadem 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Bilgen, Acibadem University
- Investigators
- Sevgi Bilgen, Assoc. Prof., Study chair, Anethesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745273
- Sponsor's protocol ID
- SevgiB
- Status last verified
- Nov 2022
- First submitted
- 31 Jan 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bilgen S, Erdogan Ari D, Ozveri E. The Effect of Ondansetron on the Analgesic Efficacy of Tramadol in Patients Undergoing Laparoscopic Cholecystectomy. Int J Clin Pract. 2022 Mar 8;2022:7387600. doi: 10.1155/2022/7387600. eCollection 2022.
PubMed 35685538
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ondansetron on the Efficacy of Tramadol
- ClinicalTrials.gov ID
- NCT04745273
- Acronym / sponsor ID
- SevgiB
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- tramadol, ondansetron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 9 Feb 2021 (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.
In the postoperative period; pain, nausea, and vomiting are undesirable side effects that reduce the patient's comfort and may lead to various complications. Ondansetron is frequently used as an antiemetic and tramadol hydrochloride is used for postoperative analgesia in laparoscopic cholecystectomy. However, some studies have reported that there is a drug interaction between these two drugs and they reduce each other's effects, thus requiring more analgesics in the postoperative period.
The aim of this study is; To evaluate whether ondansetron reduces the analgesic efficacy of tramadol hydrochloride in laparoscopic cholecystectomies.
Detailed description
During the operation, 4 mg iv ondansetron (2mL) will be administered to the ondansetron group and 2mL iv 09% saline will be administered to the placebo group. The patients' heart rate, blood pressure, oxygen saturation, sedation score (with Ramsey Seading Score), amount of pain (with NRS), degree of nausea (with NRS), whether there is vomiting, whether analgesic or antiemetic treatment is required, and the amount of tramadol use will be recorded at 1, 2, 4, 8, 12 and 24 hours in the postoperative period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Active comparator | Drug: Ondansetron 4 MG (Kemoset 4mg)Participants will receive Kemoset 4 mg iv intraoperatively |
| Salin solution | Placebo comparator | Other: Salin solutionParticipants will receive Salin solution 2ml (iv) intraoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 patients over the age of 18, ASA I-II, undergoing laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Patients under 18 years of age
- Patients with known allergies to the drugs to be used
- Pregnant and breastfeeding mothers
- Patients who received antiemetic or cortisone within 24 hours before surgery
- Patients with mental illness or epilepsy
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 MG (Kemoset 4mg)Also: KemosetOndansetron 4mg (iv) will administer to participants | Drug | Ondansetron |
| Salin solutionSalin solution 2ml (iv) will administer to participants | Other | Salin solution |
Primary outcome
Interaction
Time frame: 24 hours
The hypothesis of this study is that if ondanstron is given together with tramadol peroperatively, tramadol consumption is increase postoperatively due to tramadol ondansetron interaction. The primary outcome measure is consumption of tramadol postoperatively for 24 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 8 Nov 2022.
- Derived from this study: PubMed 35685538Bilgen S, Erdogan Ari D, Ozveri E. The Effect of Ondansetron on the Analgesic Efficacy of Tramadol in Patients Undergoing Laparoscopic Cholecystectomy. Int J Clin Pract. 2022 Mar 8;2022:7387600. doi: 10.1155/2022/7387600. eCollection 2022.
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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.
Sevgi Bilgen, Assoc. Prof. study chair
Anethesiologist
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 4 MG (Kemoset 4mg) and Salin solution in people with Cholecystectomy, Laparoscopic, run by Acibadem 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 1 inclusion and 6 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 8 Nov 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 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?
Interaction (time frame: 24 hours). 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 NCT04745273, which also lists 1 linked publication.
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 8 Nov 2022.