1mg Vs 3 mg of GranisetronPhase 3NCT04918862
A COMPARATIVE STUDY BETWEEN 1MG AND 3 MG OF GRANISETRON IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN STRABISMUS OPHTHALMIC SURGERIES DURING GENERAL ANESTHESIA
A Phase 3 study testing Granisetron in people with 1mg Vs 3 mg of Granisetron, run by Cairo University at 1 site in Egypt.
Trial summary
Investigators aim to determine the optimal dose of granisetron in strabismus ophthalmic surgeries under general anesthesia to prevent postoperative nausea and vomiting Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- 1mg Vs 3 mg of Granisetron
- What is being tested?
- Granisetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jan 2021to 18 May 2021
- Phase
- Phase 3
- 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
- • Adult patients > 18 years old.
- ASA I and II.
- Patients scheduled for strabismus surgery.
Who cannot join
- • ASA class > II.
- Patients with known hypersensitivity or contraindication to any of the study medications.
- Patients who had chronic nausea and vomiting or experienced retching, vomiting, moderate to severe nausea in the preoperative day.
- Patients who had received an antiemetic drug in the preoperative day.
- Patients with a body mass index ≥36.
- Pregnant or breast feeding female patient.
- Patients with gastrointestinal diseases.
- Patients with a history of motion sickness, diabetes mellitus, and GIT pathology (gastritis, hematemesis, peptic ulcer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of 1mg and 3 mg of Granisetron in the Prevention of Postoperative Nausea and Vomiting in Strabismus Ophthalmic Surgeries During General Anesthesia
Investigators aim to determine the optimal dose of granisetron in strabismus ophthalmic surgeries under general anesthesia to prevent postoperative nausea and vomiting
Read the detailed description
Postoperative nausea and vomiting (PONV) are common and distressing symptoms after surgery under general anesthesia. Despite advances in balanced anesthesia in recent decades, PONV can result in delayed discharge from the Post-Anesthesia Care Unit (PACU) recovery room, unexpected hospitalization and increase in medical costs.
The latest class of antiemetic for the prevention and treatment of PONV are the serotonin receptor antagonists (ondansetron, granisetron). These antiemetics do not have the negative effects of the older generations. Headache and dizziness are the main adverse effects of the serotonin receptor antagonists in the dosages used for PONV .
The FDA approved dose for the prevention of PONV is 1mg. This is based on a dose range study from Wilson and associates in which 0.1, 1.0, and 3.0 mg were associated with risk ratios for postoperative vomiting. The majority of studies on granisetron suggest that 3mg is superior to 1mg for the prevention of PONV, but those were published by a single center and there have been serious concerns about the validity of the data. In previous studies done on elective open abdominal surgery or vaginal hysterectomy but not in strabismus ophthalmic surgeries.
The ocular surgery associated with the highest incidence of PONV is strabismus surgery up to 85%. Vomiting after surgery is more likely 2-8hours than immediate postoperatively. Strabismus is a day case procedure and thus participants have to cope with emesis in the recovery room, or when traveling, or at home.
In this study, investigators compared two doses of granisetron in strabismus ophthalmic surgeries under general anesthesia
- Conditions
- 1mg Vs 3 mg of Granisetron
- Being tested
- Granisetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GranisetronDrug
Also called Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during general anesthesia.
210 patients were enrolled, divided into two groups [Granisetron 1 mg: 105 patients received 1mg granisetron, Granisetron 3 mg: 105 patients received 3mg granisetron]. The two groups were compared in demographic characteristics (age, gender, weight, and height), hemodynamic parameters (MAP and HR), and duration of surgery
| Study group | Role | What they receive |
|---|---|---|
| Granisetron 1 mg | Active comparator | Granisetron 1 mg: 105 patients received 1mg granisetron Receives: Drug: Granisetron |
| Granisetron 3 mg | Active comparator | Granisetron 3 mg: 105 patients received 3mg granisetron Receives: Drug: Granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative
The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative
Measured: Up to 24 hours
Secondary outcomes (4)
Detection of the optimal dose of granisetrone
Detection of the optimal dose of granisetrone/mg
Measured: Up to 24 hours
Detection of either attacks of nausea and vomiting occurred post operatively or not. •
Detection of either attacks of nausea and vomiting occurred post operatively or not
Measured: Post operatively over the first 24 hrs postoperative .
Blood Pressure
Blood Pressure measurment mmHg
Measured: Up to 24 hours
Heart Rate
Heart Rate measurment beat /minute
Measured: Up to 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 Jun 2021
- Study start8 Jan 2021
- Primary completion9 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 1mg Vs 3 mg of GranisetronStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 210 patients were recruited and allocated randomly to receive either granisetron 1.0mg (n =105) or granisetron 3.0mg (n =105). The two groups were compared regarding: demographic data of the patients, hemodynamic parameters including mean arterial pressure and heart rate and percentage of patients with no complain of postoperative nausea and vomiting at first 24 hours.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed Yousry Mohamed, Tamer Fayez Safan, Tamer Mohamed Khair, Mohamed, Ahmed A., M.D., Islam Mohamed Sayed
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Ahmed A Mohamed, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918862
- Sponsor's protocol ID
- MS-380-2020
- Status last verified
- Jun 2021
- First submitted
- 20 May 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till Submission
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of 1mg and 3 mg of Granisetron in the Prevention of Postoperative Nausea and Vomiting in Strabismus Ophthalmic Surgeries During General Anesthesia
- ClinicalTrials.gov ID
- NCT04918862
- Acronym / sponsor ID
- MS-380-2020
- Conditions
- 1mg Vs 3 mg of Granisetron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mohamed Yousry Mohamed, Tamer Fayez Safan, Tamer Mohamed Khair, Mohamed, Ahmed A., M.D., Islam Mohamed Sayed
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 9 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 9 Jun 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.
Investigators aim to determine the optimal dose of granisetron in strabismus ophthalmic surgeries under general anesthesia to prevent postoperative nausea and vomiting
Detailed description
Postoperative nausea and vomiting (PONV) are common and distressing symptoms after surgery under general anesthesia. Despite advances in balanced anesthesia in recent decades, PONV can result in delayed discharge from the Post-Anesthesia Care Unit (PACU) recovery room, unexpected hospitalization and increase in medical costs.
The latest class of antiemetic for the prevention and treatment of PONV are the serotonin receptor antagonists (ondansetron, granisetron). These antiemetics do not have the negative effects of the older generations. Headache and dizziness are the main adverse effects of the serotonin receptor antagonists in the dosages used for PONV .
The FDA approved dose for the prevention of PONV is 1mg. This is based on a dose range study from Wilson and associates in which 0.1, 1.0, and 3.0 mg were associated with risk ratios for postoperative vomiting. The majority of studies on granisetron suggest that 3mg is superior to 1mg for the prevention of PONV, but those were published by a single center and there have been serious concerns about the validity of the data. In previous studies done on elective open abdominal surgery or vaginal hysterectomy but not in strabismus ophthalmic surgeries.
The ocular surgery associated with the highest incidence of PONV is strabismus surgery up to 85%. Vomiting after surgery is more likely 2-8hours than immediate postoperatively. Strabismus is a day case procedure and thus participants have to cope with emesis in the recovery room, or when traveling, or at home.
In this study, investigators compared two doses of granisetron in strabismus ophthalmic surgeries under general anesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 210 patients were recruited and allocated randomly to receive either granisetron 1.0mg (n =105) or granisetron 3.0mg (n =105). The two groups were compared regarding: demographic data of the patients, hemodynamic parameters including mean arterial pressure and heart rate and percentage of patients with no complain of postoperative nausea and vomiting at first 24 hours.
| Arm | Type | Receives |
|---|---|---|
| Granisetron 1 mg | Active comparator | Drug: GranisetronGranisetron 1 mg: 105 patients received 1mg granisetron |
| Granisetron 3 mg | Active comparator | Drug: GranisetronGranisetron 3 mg: 105 patients received 3mg granisetron |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Adult patients > 18 years old.
Key exclusion criteria (8 listed)
- • ASA class > II.
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: Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during general anesthesia.210 patients were enrolled, divided into two groups [Granisetron 1 mg: 105 patients received 1mg granisetron, Granisetron 3 mg: 105 patients received 3mg granisetron]. The two groups were compared in demographic characteristics (age, gender, weight, and height), hemodynamic parameters (MAP and HR), and duration of surgery | Drug | Granisetron 1 mg, Granisetron 3 mg |
Primary outcome
The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative
Time frame: Up to 24 hours
The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative
4 secondary outcomes
Detection of the optimal dose of granisetrone
Time frame: Up to 24 hours
Detection of either attacks of nausea and vomiting occurred post operatively or not. •
Time frame: Post operatively over the first 24 hrs postoperative .
Blood Pressure
Time frame: Up to 24 hours
Heart Rate
Time frame: Up to 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 21 Jun 2021.
- Individual participant dataSharing planned: Undecided. Till Submission
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.
Ahmed A Mohamed, M.D principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Granisetron in people with 1mg Vs 3 mg of Granisetron, run by Cairo 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 3 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: finished, as of the sponsor's last update on 21 Jun 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative (time frame: Up to 24 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 21 Jun 2021.