Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428084
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-16
Brief Title:
Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing PONV
Sponsor:
Universitas Padjadjaran
Organization:
Universitas Padjadjaran
Study Overview
Official Title:
Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy A Randomized Controlled Trial
Status:
COMPLETED
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:
Nausea and vomiting following laparoscopic cholecystectomy remain common with occurrence rates of 40-70 during the initial 24 hours post-operation The underlying mechanisms of postoperative nausea and vomiting engage five distinct neurotransmitter receptors Consequently employing a combination of antiemetics from diverse classes that target various receptors for effective prevention is advised Ondansetrons antiemetic properties derive from its ability to inhibit serotonin receptors whereas Haloperidol targets dopamine receptors and Dexamethasone reduces prostaglandin production
Detailed Description:
Postoperative nausea and vomiting PONV are also known as the little problem interpreted as a seemingly less significant complication but lead to increased morbidity longer hospital stays increased medical costs and diminished patient satisfaction with healthcare services These symptoms are reported more frequently than postoperative pain making its prevention as important as postoperative pain management In laparoscopic cholecystectomy the occurrence of PONV can range from 40 - 70 which is higher than the 33 - 49 observed in other types of surgeries under general anesthesia within the first 24 hours post-procedure The mechanism of PONV is complex involving multiple neurotransmitters Targeted neurotransmitter receptors in the action of antiemetic drugs include muscarinic-1-acetylcholine M1 dopamine-2 D2 histamine-1 H1 5-Hydroxytryptamine-3-serotonin 5HT3 and neurokinin1-substance P NK1 receptors Based on this the prevention of postoperative nausea and vomiting is recommended using a combination of various groups of antiemetics that work on different receptors Studies have shown that combining different antiemetic classes is more effective than using a single agent A meta-analysis study stated that dexamethasone ondansetron and droperidol are the most used types of antiemetics alone or in combination Dexamethasone with a 5HT3 antagonist such as ondansetron is the most used antiemetic combination Another viable option includes dexamethasone with Butypherone group drugs such as droperidol which acts as a D2 antagonist However droperidol was subject to FDA black box warnings in 2003 due to its association with arrhythmias caused by QT interval prolongation Subsequent research has suggested haloperidol another Butypherone group drug as a safer alternative to droperidol
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