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Minerva Anestesiologica 1998 December;64(12):553-61

Copyright © 1999 EDIZIONI MINERVA MEDICA

language: Italian

Oral Granisetron as prophylaxis for nausea and vomiting during fluorescein angiography. A multicentre, double-blind, randomised, parallel group, placebo-controlled study

Mattioli V. 1, Calò A. 2, Pisoni G. 3, Ancona G. 4, Zollino P. 5, Brunetti P. 6

1 Operational Unit of Anaesthesia and Resuscitation, AUSL Ba5 Paradiso Hospital - Gioia del Colle (Bari); 2 Operational Unit of Anaesthesia and Resuscitation, AUSL Ba5 S. Maria degli Angeli Hospital, Putignano (Bari); 3 Medical Department, Smith Kline Beecham Pharmaceuticals - Milan; 4 Operational Unit of Anaesthesia and Resuscitation, AOSL Di Venere-Giovanni XXIII Hospital - Bari; 5 Operational Unit of Anaesthesia and Resuscitation, AOSL SS. Annunziata Hospital - Taranto; 6 Operational Unit of Anaesthesia and Resuscitation, Miulli Religious Hospital - Acquaviva delle Fonti (Bari)


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Background. 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.
Experimental plan. Multicentre, randomised, double-blind, placebo-controlled study, with a follow-up visit performed 24 hrs after FAG.
Environment. Five Anaesthesia/Resuscitation and Ophthalmology operational units participated in the study.
Patients. 120 patients (24 from each Centre) of both sexes and aged >18 years, suffering from retinal disorders, were enrolled after informed consent. Pregnancy, lactation, antineoplastic treatment, ASA status IV/V were main exclusion criteria. All recruired patients completed the study.
Interventions. 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.
Survey. In both groups nausea, retching and vomiting were seen after fluorescein injection.
Results. The study demonstrated that Granise-tron 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 χ2, p≤0.05.
Conclusions. The results suggest that Granise-tron 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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