A comparative study of the antiemetic efficacy of dexamethasone, ondansetron, and metoclopramide in patients undergoing gynecological surgery.
Tugsan Egemen Bilgin, Handan Birbicer, Zeliha Ozer...
https://pubmed.ncbi.nlm.nih.gov/20581776/Actively Recruiting
Led by Alexandria University · Updated on 2025-07-25
210
Participants Needed
1
Research Sites
13 weeks
Total Duration
Postoperative nausea and vomiting PONV frequently occur after ambulatory surgeries like cataract surgery, affecting up to 80% of high-risk patients and 20-30% overall. PONV can disrupt recovery, delay discharge, increase medical costs, and lower patient satisfaction. It may also lead to serious complications such as suprachoroidal hemorrhage SCH, a condition involving bleeding in the eye. This study evaluates whether dexamethasone can reduce PONV incidence compared to metoclopramide in adults undergoing cataract surgery. Participants are randomized into three groups one receiving 8 mg dexamethasone, another 10 mg metoclopramide, and a placebo group receiving saline. All patients receive sedation with midazolam, ketamine, and nalbuphine, along with a peribulbar block using lidocaine and bupivacaine. The study is double-blind and placebo-controlled, conducted at Alexandria University hospitals, with medication administered before sedation. Rescue antiemetic ondansetron and analgesic ketorolac drugs are available if needed. During the study, participants undergo preoperative evaluation including history, examination, and laboratory tests. Standard monitoring includes ECG, blood pressure, and oxygen saturation. Researchers assess nausea severity, vomiting incidence, pain scores, and use of rescue medications on the first postoperative day. The primary outcome is the number of patients experiencing nausea and vomiting post-surgery. Secondary outcomes include pain levels and side effects such as dizziness, itching, and headache. The study aims to improve management of PONV to enhance patient recovery and satisfaction.
CONDITIONS
Dexamethasone Versus Metoclopramide for Prophylaxis of Nausea and Vomiting After Cataract Surgery
S
sarah m elgamal, MD
M
moutaz ghandour, MD
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Alexandria University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day during surgery
Participants receive one of three study medications before sedation: dexamethasone, metoclopramide, or saline placebo. All receive sedation and a nerve block for surgery.
1 visit (in-person)
Duration - 1 day after surgery
Researchers assess nausea, vomiting, pain, and side effects on the first day after surgery. Rescue medications are available if needed.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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Tugsan Egemen Bilgin, Handan Birbicer, Zeliha Ozer...
https://pubmed.ncbi.nlm.nih.gov/20581776/Alexandria University
Lead Sponsor