Nausea and Vomiting, PostoperativePhase 4NCT04899817
Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy
A Phase 4 study testing Granisetron in people with Nausea and Vomiting, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- Granisetron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- May 2021to Apr 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- both sexes Age between 18 and 60 years ASA1 2 3 Lap cholecystectomy under general anesthesia
Who cannot join
- patients refusal Pregnancy and breastfeeding Hepatic or renal disease ASA4 5 Allergy to the drug
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university hospital
Asyut, 71515
Layali S Dardeer, 01096928662, as0296856@gmail.com
About this study
Official title: Efficacy and Safety of Granisteron Versus Metoclopramide as Prophylaxis Antiemetic in Laparoscopic Cholecystectomy
Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy
Read the detailed description
Post operative nausea and vomitting is Avery common complication of laparoscopic surgery in that study we will compare between granisteron and metoclopramide as aprophlaxis against post operative nausea and vomitting
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- Granisetron
- Keywords
- Laparoscopic cholecystectomy
- 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.
GranisetronDrug
Also called Granitryl
The drug is given after induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group G | Active comparator | will receive granisteron 1mg after induction of general anesthesia Receives: Drug: Granisetron |
| Group C | Placebo comparator | Will receive metoclopramide 10 mg after induction of general anesthesia Receives: Drug: Granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomitting
Number of attacks of nausea and vomitting
Measured: Every 2 hours for 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study startMay 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyali Salah Dardeer, Assiut University
- Investigators
- Eman M Esmail, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899817
- Sponsor's protocol ID
- Antiemetics in lab cholecystec
- Status last verified
- May 2021
- First submitted
- 20 Apr 2021
- Last updated
- 25 May 2021
- 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 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Granisteron Versus Metoclopramide as Prophylaxis Antiemetic in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04899817
- Acronym / sponsor ID
- Antiemetics in lab cholecystec
- Conditions
- Nausea and Vomiting, Postoperative
- Keywords
- Laparoscopic cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 25 May 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.
Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy
Detailed description
Post operative nausea and vomitting is Avery common complication of laparoscopic surgery in that study we will compare between granisteron and metoclopramide as aprophlaxis against post operative nausea and vomitting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group G | Active comparator | Drug: Granisetronwill receive granisteron 1mg after induction of general anesthesia |
| Group C | Placebo comparator | Drug: GranisetronWill receive metoclopramide 10 mg after induction of general anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- both sexes Age between 18 and 60 years ASA1 2 3 Lap cholecystectomy under general anesthesia
Key exclusion criteria (1 listed)
- patients refusal Pregnancy and breastfeeding Hepatic or renal disease ASA4 5 Allergy to the drug
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 |
|---|---|---|
| GranisetronAlso: GranitrylThe drug is given after induction of general anesthesia | Drug | Group C, Group G |
Primary outcome
Postoperative nausea and vomitting
Time frame: Every 2 hours for 12 hours
Number of attacks of nausea and vomitting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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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.
Eman M Esmail study director
Assiut University
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 Granisetron in people with Nausea and Vomiting, Postoperative, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 25 May 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Layali Dardeer (01096928662, as0296856@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomitting (time frame: Every 2 hours for 12 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 25 May 2021.