Oral granisetron as prophylaxis for nausea and vomiting during fluorescein angiography. a multicentre, double-blind, randomised, parallel group, placebo-controlled study
Mattioli, V.; Calò, A.; Pisoni, G.; Ancona, G.; Zollino, D.; Brunetti, P.
Minerva Anestesiologica 64(12): 553-561
1998
ISSN/ISBN: 0375-9393 PMID: 10085671 Document Number: 7257
Prophylaxis with oral Granisetron was assessed in patients undergoing fluorescein angiography (FAG) in order to evaluate its efficacy in reducing patients' discomfort due to nausea and vomiting (4% > 20%) and to ensure completion of the investigation. Multicentre, randomised, double-blind, placebo-controlled study, with a follow-up visit performed 24 hrs after FAG. Five Anaesthesia/Resuscitation and Ophthalmology operational units participated in the study. 120 patients (24 from each Centre) of both sexes and aged > 18 years, suffering from retinal disorders, were enrolled after informed consent. Pregnancy, lactation, anti-neoplastic treatment, ASA status IV/V were main exclusion criteria. All recruired patients completed the study. Ophthalmological evaluation was performed 30 days before and the same day as FAG. Anaesthesiological assessment on the same day as FAG, recording, BP, HR, ASA status, allergic diathesis, allergy to medications and contrast media, concomitant treatments. Oral Granisetrom 1 mg or placebo was given on an empty stomach 1 hr before the injection of 5 ml 20% fluorescein in 3 sec. A follow-up examination was done 24 hrs after FAG. In both groups nausea, retching and vomiting were seen after fluorescein injection. The study demonstrated that Granisetron is more active than placebo in controlling nausea (3 cases vs 4), and retching (2 vs 6). It was significantly more effective than placebo in the prevention of vomiting (0 vs 3). Efficacy was evaluated with chi 2, p < or = 0.05). The results suggest that Granisetron may be indicated as prophylaxis in patients undergoing FAG in order to prevent or control emesis, improve patients' comfort and ensure successful outcome of the investigation.
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