Postoperative Nausea and VomitingPhase 3NCT03483350
Comp Granisetron Midazolam Comb in Lap Children
A Phase 3 study testing Granisetron and Midazolam in people with Postoperative Nausea and Vomiting, run by Assiut University.
Trial summary
Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients. The physiology of PONV is complex and not perfectly understood. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Granisetron and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Jan 2019
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- This study will include children, scheduled for elective Laparoscopic surgery
- Age 4-12 years
- ASA I or II
- Exclusion Criteria: Patients will be excluded who meet these criteria
- Patient refusal
- Any contraindication of laparoscopic surgery;as personal history of seizures, peripheral neurologic diseases, cardiac arrhythmias, liver disease, renal dysfunction and cardiac conduction abnormalises
- Known allergy to the drugs included in the study
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Granisetron Versus Midazolam and Thier Combination for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Surgery in Children
Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients.
The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons.
Read the detailed description
Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients.
The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons. The CRTZ receives input from vagal afferents in the gastrointestinal tract, and it can also detect emetogenic toxins, metabolites, and drugs circulating in the blood and cerebrospinal fluid due to its lack of the bloodbrain barrier. Multiple neurotransmitter pathways are implicated in the physiology of nausea and vomiting. Enterochromaffin cells in the gastrointestinal tract release serotonin, and the vagus nerve communicates with the CRTZ via 5-HT3 receptors. The CRTZ communicates with the NTS primarily via dopamine-2 (D2) receptors.
PONV may increase hospital expenditure by prolongation of hospital stay, and management of vomiting related complications such as dehydration, electrolyte disturbances, and pulmonary aspiration. Pediatric laparoscopic surgery is commonly associated with higher incidence of PONV. Mixtures of different classes of antiemetics have been used successfully to decrease the incidence of PONV but there was no agreement on the optimal combination. Granisetron a newer 5-HT3 antagonist has stronger receptor binding and has been found to be more potent and longer acting as antiemetic for preventing postoperative nausea and vomiting following laparoscopic surgery. Midazolam is commonly used as a premedication to relief anxiety. Midazolam given intravenously before the end of surgery was effective in decreasing the incidence of PONV. sub-hypnotic dose of midazolam was suggested that have a role in the management of PONV.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Granisetron, Midazolam
- 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
Ampoule
MidazolamDrug
Ampoule
| Study group | Role | What they receive |
|---|---|---|
| 1- 1st group | Experimental | 1- 1st group will include 30 patients will receive intravenous granisetron 10 μg/kg after induction of anesthesia and before start of surgery Receives: Drug: Granisetron |
| 2- 2nd | Experimental | 2- 2nd group will include 30 patients will receive intravenous midazolam 50 μg/kg after induction of anesthesia and before start of surgery Receives: Drug: Midazolam |
| 3- 3rd group | Experimental | 3- 3rd group will include 30 patients will receive combination intravenous granisetron 5 μg/kg with midazolam 25 μg/kg after induction of anesthesia and before start of surgery Receives: Drug: Granisetron; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vomiting score
Have you vomited?
0 - No, 1 - Once, 2 - Twice, 3 - Three or more time
Measured: for48hours(two day)
Secondary outcomes (1)
Nausea score
Have you experienced feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit)
0-No 1-Yes
Measured: for48hours(two day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionJan 2019 (estimated)
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 Postoperative Nausea and VomitingStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesam Nashat Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483350
- Sponsor's protocol ID
- Gmpl
- Status last verified
- Mar 2018
- First submitted
- 13 Feb 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
PubMed 12818945
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Granisetron Versus Midazolam and Thier Combination for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Surgery in Children
- ClinicalTrials.gov ID
- NCT03483350
- Acronym / sponsor ID
- Gmpl
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 30 Mar 2018 (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.
Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients.
The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons.
Detailed description
Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients.
The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons. The CRTZ receives input from vagal afferents in the gastrointestinal tract, and it can also detect emetogenic toxins, metabolites, and drugs circulating in the blood and cerebrospinal fluid due to its lack of the bloodbrain barrier. Multiple neurotransmitter pathways are implicated in the physiology of nausea and vomiting. Enterochromaffin cells in the gastrointestinal tract release serotonin, and the vagus nerve communicates with the CRTZ via 5-HT3 receptors. The CRTZ communicates with the NTS primarily via dopamine-2 (D2) receptors.
PONV may increase hospital expenditure by prolongation of hospital stay, and management of vomiting related complications such as dehydration, electrolyte disturbances, and pulmonary aspiration. Pediatric laparoscopic surgery is commonly associated with higher incidence of PONV. Mixtures of different classes of antiemetics have been used successfully to decrease the incidence of PONV but there was no agreement on the optimal combination. Granisetron a newer 5-HT3 antagonist has stronger receptor binding and has been found to be more potent and longer acting as antiemetic for preventing postoperative nausea and vomiting following laparoscopic surgery. Midazolam is commonly used as a premedication to relief anxiety. Midazolam given intravenously before the end of surgery was effective in decreasing the incidence of PONV. sub-hypnotic dose of midazolam was suggested that have a role in the management of PONV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1- 1st group | Experimental | Drug: Granisetron1- 1st group will include 30 patients will receive intravenous granisetron 10 μg/kg after induction of anesthesia and before start of surgery |
| 2- 2nd | Experimental | Drug: Midazolam2- 2nd group will include 30 patients will receive intravenous midazolam 50 μg/kg after induction of anesthesia and before start of surgery |
| 3- 3rd group | Experimental | Drug: Granisetron, Drug: Midazolam3- 3rd group will include 30 patients will receive combination intravenous granisetron 5 μg/kg with midazolam 25 μg/kg after induction of anesthesia and before start of surgery |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- This study will include children, scheduled for elective Laparoscopic surgery
- Age 4-12 years
- ASA I or II
- Exclusion Criteria: Patients will be excluded who meet these criteria
- Patient refusal
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GranisetronAmpoule | Drug | 1- 1st group, 3- 3rd group |
| MidazolamAmpoule | Drug | 2- 2nd, 3- 3rd group |
Primary outcome
Vomiting score
Time frame: for48hours(two day)
Have you vomited? 0 - No, 1 - Once, 2 - Twice, 3 - Three or more time
1 secondary outcome
Nausea score
Time frame: for48hours(two day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Background: PubMed 12818945Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Granisetron and Midazolam in people with Postoperative Nausea and Vomiting, run by Assiut University.
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 7 inclusion and 0 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 30 Mar 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zein ElAbideen Zareh Hassan Zareh Hassan, MD (01005187371, zein20002002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vomiting score (time frame: for48hours(two day)). 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 NCT03483350, 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 30 Mar 2018.