Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-01 @ 3:14 PM
Study NCT ID:
NCT03483350
Status:
UNKNOWN
Last Update Posted:
2018-03-30
First Post:
2018-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comp Granisetron Midazolam Comb in Lap Children
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Comparison of Granisetron Versus Midazolam and Thier Combination for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Surgery in Children
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: