Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017167
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-08-14
Brief Title:
Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Status:
RECRUITING
Status Verified Date:
2023-08
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:
The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group
The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy
The secondary outcomes are
The severity of post operative nausea and vomiting
Use of rescue antiemetic drugs
Postoperative pain and sedation
The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy
The secondary outcomes are
The severity of post operative nausea and vomiting
Use of rescue antiemetic drugs
Postoperative pain and sedation
Detailed Description:
General anesthesia is widely used in several surgeries It can cause some complications such as postoperative nausea and vomiting PONV PONV is more common in general anesthesia than spinal anesthesia PONV remains an extremely significant challenge due to its complex mechanism resulting in serious consequences Therefore an effective way to prevent or arrest PONV is urgently needed as Also it can cause electrolyte imbalance and aggravate bleeding that delay hospital discharge
The causes of PONV are multifactorial and can largely be categorized as patient risk factors anaesthetic technique and surgical procedure Antiemetics work on several different receptor sites to prevent or treat PONV
No single antiemetic pharmaceutical has been provided to be a universal solution to PONV In general multimodal combination treatment has superior viability for PONV prophylaxis compared with monotherapy
Because nausea and vomiting were defined as two separate phe-nomena studies should report and evaluate the variables distinctly While since few patients experience vomiting without nausea the incidence of PONV and postoperative nausea PON is fairly similar thus original papers often do not try to distinguish these variables So if PONV but not PON was reported in trails we considered the PONV variables as a very close substitute for PON when both PONV and PON were reported simultaneously we assessed the nausea values The most commonly used time interval to measure the role of antiemetic is 24 hours 6
Ondansetron is a serotonin receptor antagonist which is very important in preventing nausea and vomiting due to surgery and chemotherapy it exhibited an anti-vomiting effect by inhibiting 5-Hydroxytryptamine type 3 5-HT3 receptors in the vomiting centre
Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist which binds to transmembrane G protein-binding receptor located in the brain and spinal cord Since nausea and vomiting may be induced by high catecholamine concentrations a decrease of sympathetic tone could explain the antiemetic effect of dexmedetomidine Finally consumption of intraoperative opioids which increases the risk of PONV may be reduced through the use of dexmedetomidine It affects the functions of central nervous circulatory systems and exhibits sedative analgesic sympatholytic properties Recently the effect of dexmedetomidine on PONV has been the focus of clinical researchers Nevertheless controversy about the effectiveness of dexmedetomidine for PONV is still ongoing for different results reported in associated literature
Glucocorticoids may exert an antiemetic effect by inhibiting inflammatory mediators and by interacting with serotonin neurokinin a-adrenergic receptors and other receptors Furthermore several studies have shown that dexamethasone enhances the antiemetic efficacies of 5-hydroxytryptamine type 3 5-HT3 receptor antagonists
The causes of PONV are multifactorial and can largely be categorized as patient risk factors anaesthetic technique and surgical procedure Antiemetics work on several different receptor sites to prevent or treat PONV
No single antiemetic pharmaceutical has been provided to be a universal solution to PONV In general multimodal combination treatment has superior viability for PONV prophylaxis compared with monotherapy
Because nausea and vomiting were defined as two separate phe-nomena studies should report and evaluate the variables distinctly While since few patients experience vomiting without nausea the incidence of PONV and postoperative nausea PON is fairly similar thus original papers often do not try to distinguish these variables So if PONV but not PON was reported in trails we considered the PONV variables as a very close substitute for PON when both PONV and PON were reported simultaneously we assessed the nausea values The most commonly used time interval to measure the role of antiemetic is 24 hours 6
Ondansetron is a serotonin receptor antagonist which is very important in preventing nausea and vomiting due to surgery and chemotherapy it exhibited an anti-vomiting effect by inhibiting 5-Hydroxytryptamine type 3 5-HT3 receptors in the vomiting centre
Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist which binds to transmembrane G protein-binding receptor located in the brain and spinal cord Since nausea and vomiting may be induced by high catecholamine concentrations a decrease of sympathetic tone could explain the antiemetic effect of dexmedetomidine Finally consumption of intraoperative opioids which increases the risk of PONV may be reduced through the use of dexmedetomidine It affects the functions of central nervous circulatory systems and exhibits sedative analgesic sympatholytic properties Recently the effect of dexmedetomidine on PONV has been the focus of clinical researchers Nevertheless controversy about the effectiveness of dexmedetomidine for PONV is still ongoing for different results reported in associated literature
Glucocorticoids may exert an antiemetic effect by inhibiting inflammatory mediators and by interacting with serotonin neurokinin a-adrenergic receptors and other receptors Furthermore several studies have shown that dexamethasone enhances the antiemetic efficacies of 5-hydroxytryptamine type 3 5-HT3 receptor antagonists
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