A Phase 3 interventional study of Granisetron and Midazolam in Postoperative Nausea and Vomiting, sponsored by Assiut University. Status unknown. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-30.
Sponsored by Assiut University · Phase 3, Interventional, and Prevention
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Among 12 studies testing granisetron in Postoperative Nausea and Vomiting — 1 open to participants now, 1 under way, none of them phase 3. Granisetron · Postoperative Nausea and Vomiting.
Among the 12 studies testing granisetron in Postoperative Nausea and Vomiting, this one is the 8th largest by planned enrollment, is one of 4 that started in 2018, is one of 3 in phase 3, and was the 4th registered.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
Browse Postoperative Nausea and Vomiting studies →1 of the 12 studies testing granisetron in Postoperative Nausea and Vomiting is open now. Recruiting first, the newest first:
Assiut University
Ages 18–60 · Women only
Granisetron: first FDA approval 1993 (KYTRIL), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 65 Postoperative Nausea and Vomiting studies recruiting now, 22 (34%) set no upper age limit and 37 (57%) stop at 75 or younger; 14 take children under 18; 11 take healthy volunteers.
This study: 4 Years to 12 Years · all sexes · healthy volunteers too.
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12 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Median enrollment 97 across the 12 interventional studies. Of the 7 that completed or were terminated, 3 (43%) have results posted.
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None of the 12 has an industry lead sponsor. The 10 most frequent:
Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
14 studies in Postoperative Nausea and Vomiting by Assiut University: 4 open now, 4 under way, none of them phase 3. Of 7 finished, 0 (0%) have results posted.
Among the 14 studies in Postoperative Nausea and Vomiting by Assiut University, this one is the 9th largest by planned enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is the only one in phase 3, and was the 7th registered.
Assiut University’s Postoperative Nausea and Vomiting studies by the year they started, since 2015.
1 of the studies testing granisetron in Postoperative Nausea and Vomiting that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07360431Assiut UniversityGranisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy | 2027-10 |
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Among the 12 studies testing granisetron in Postoperative Nausea and Vomiting, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Assiut University’s 14 in Postoperative Nausea and Vomiting:
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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.
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.
Inclusion Criteria:
Exclusion Criteria: Patients will be excluded who meet these criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1- 1st group will include 30 patients will receive intravenous granisetron 10 μg/kg after induction of anesthesia and before start of surgery
Drug: Granisetron
2- 2nd group will include 30 patients will receive intravenous midazolam 50 μg/kg after induction of anesthesia and before start of surgery
Drug: Midazolam
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
Drug: Granisetron · Drug: Midazolam
Ampoule
Ampoule
Vomiting score
Have you vomited? 0 - No, 1 - Once, 2 - Twice, 3 - Three or more time
Time frame: for48hours(two day)
Nausea score
Have you experienced feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit) 0-No 1-Yes
Time frame: for48hours(two day)
No study locations are listed for this record.
Start is estimated for Mar 2018; primary completion for Aug 2018, 5 months later.
Of 22 phase 3 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Granisetron · Midazolam
Postoperative Nausea and Vomiting →