Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437236
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-20
Brief Title:
Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery A Randomized Double-Blind Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
Spinal anesthesia is commonly used in cesarean section surgeries The most important adverse effects of spinal anesthesia are hypotension and bradycardia caused by sympathetic blockade with an incidence of about 55-100 However blocking the venous return by the gravid uterus increases the risk of hypotension Spinal anesthesia-induced hypotension is commonly associated with uncomfortable symptoms such as shivering nausea and vomiting in the mother Prolonged maternal hypotension may lead to serious maternal adverse effects such as cardiovascular collapse loss of consciousness apnea and aspiration of gastric contents In addition uteroplacental blood flow decreases in cases of sustained hypotension and detrimental neonatal effects such as fetal acidosis and fetal death may occur Preventing spinal anesthesia-induced hypotension during cesarean section is essential for the well-being of both the mother and neonate
Also Shivering often happens after spinal anesthesia Shivering is an unconscious and rhythmic movement involving several groups of muscles The increase of muscle activity generates the elevation of oxygen consumption lactic acidosis and carbon dioxide production In recent years researchers have focused on the effects of the Bezold-Jarisch reflex BJR This reflex includes a triad of bradycardia hypotension and apnea Researchers have suggested that serotonin and 5-hydroxytryptamine 3 5-HT3 receptors play an important role in the occurrence of the BJR after spinal anesthesia The 5-HT3 receptors are present in the heart lung and spine Diminished venous return caused by spinal anesthesia stimulates the cardiac chemoreceptors and parasympathetic activity increases which results in bradycardia and hypotension Studies have suggested that the use of 5-HT3 antagonists may attenuate spinal anesthesia-induced hypotension thus inhibiting peripheral vasodilatation alleviating the BJR and increasing venous return to the heart Ondansetron is a commonly used 5-HT3 receptor antagonist and its peak plasma concentration occurs within 30 min following IV injection Granisetron is a new 5-HT3 receptor antagonist and the onset of action occurs 30 min following its IV administration
Also Shivering often happens after spinal anesthesia Shivering is an unconscious and rhythmic movement involving several groups of muscles The increase of muscle activity generates the elevation of oxygen consumption lactic acidosis and carbon dioxide production In recent years researchers have focused on the effects of the Bezold-Jarisch reflex BJR This reflex includes a triad of bradycardia hypotension and apnea Researchers have suggested that serotonin and 5-hydroxytryptamine 3 5-HT3 receptors play an important role in the occurrence of the BJR after spinal anesthesia The 5-HT3 receptors are present in the heart lung and spine Diminished venous return caused by spinal anesthesia stimulates the cardiac chemoreceptors and parasympathetic activity increases which results in bradycardia and hypotension Studies have suggested that the use of 5-HT3 antagonists may attenuate spinal anesthesia-induced hypotension thus inhibiting peripheral vasodilatation alleviating the BJR and increasing venous return to the heart Ondansetron is a commonly used 5-HT3 receptor antagonist and its peak plasma concentration occurs within 30 min following IV injection Granisetron is a new 5-HT3 receptor antagonist and the onset of action occurs 30 min following its IV administration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None