Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06428084 |
| Other study ID # |
AN-202405.01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2023 |
| Est. completion date |
February 28, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Universitas Padjadjaran |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. Ondansetron's antiemetic properties derive
from its ability to inhibit serotonin receptors, whereas Haloperidol targets dopamine
receptors, and Dexamethasone reduces prostaglandin production.
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.
