-
Study aim
-
Comparing antiemetic effect of Promethazine, Dexamethasone, Ondansetron and Haloperidol, Dexamethazone, Ondansetron after laparoscpoic bariatric surgery.
-
Design
-
This is a two arm parallel double blind clinical trial. The participants are selected from patients aged 18-65 years who are candidates for laparoscopic bariatric surgery and have the inclusion criteria. Eighty patients are divided to two equal groups through simple randomization using a random number table. Group A receives a three-drug regimen (Ondansetron 4 mg, Dexamethasone 8 mg and Haloperidol 2 mg) and group B receives Ondansetron 4 mg, Dexamethasone 8 mg and Promethazine 25 mg for PONV prophylaxis.
-
Settings and conduct
-
This is a randomized two arm parallel double blind clinical trial in Sina hospital.Patients and researcher are not informed of each patient's intervention group. Post operative follow up is done by researcher who knows the patient's names but not the antiemetic used.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
• Age 18-65 years
• BMI>30 Kg/m2
• ASA class I or II
Exclusion criteria:
• Contraindication to dexamethasone, ondansetron, haloperidol, and promethazine
• Use of illicit drugs, hormonal anti-inflammatory drugs, and antiemetics within 24 hours before surgery
• Serious adverse reaction like shock, cardiac arrest, and hemorrhage requiring transfusion
• History of prolonged QT
-
Intervention groups
-
Group A receives a three-drug regimen (Ondansetron 4 mg, Dexamethasone 8 mg and Haloperidol 2 mg) and group B receives Ondansetron 4 mg, Dexamethasone 8 mg and Promethazine 25 mg.
-
Main outcome variables
-
Post operative nausea and vomiting score at recovery room, 6 and 24 hours after surgery, First time of antiemetic prescription after surgery until 24 hours, Accumulative dose of antiemetics prescription after surgery until 24 hours, Recovery time