Postoperative Nausea and Vomiting Clinical Trial
Official title:
A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia
Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea
and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence
may be the long duration of surgery and anesthesia and the high degree of manipulation of
the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset
of several complications, such as suprachoroidal hemorrhage, with disastrous visual
consequences.
To date there is no evidence as to the possible protective effect of anti-emetic therapy
with regard to interventions of vitrectomy performed under local anesthesia.
In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy
of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and
vomiting in patients undergoing vitrectomy under local anesthesia.
Patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3
pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery
and 15 minutes before the end of surgery.
The syringes were prepared by a third, neutral person not involved in the perioperative care
of the patient, immediately before the start of anesthesia.
All vitrectomy surgeries were performed, in each unit,under local anesthesia by a
retrobulbar block.
Each patients was observed and treated during a period of 24 hours after the surgery. For
patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a
rescue dose of 4 mg ondansetron IV.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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