• Minerva anestesiologica · Dec 1998

    Randomized Controlled Trial Multicenter Study Clinical Trial

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

    • V Mattioli, A Calò, G Pisoni, G Ancona, D Zollino, and P Brunetti.
    • Operational Unit of Anaesthesia and Resuscitation, AUSL Ba5 Paradiso Hospital, Gioia del Colle, Bari.
    • Minerva Anestesiol. 1998 Dec 1;64(12):553-61.

    BackgroundProphylaxis 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 PlanMulticentre, randomised, double-blind, placebo-controlled study, with a follow-up visit performed 24 hrs after FAG.EnvironmentFive Anaesthesia/Resuscitation and Ophthalmology operational units participated in the study.Patients120 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.InterventionsOphthalmological 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.SurveyIn both groups nausea, retching and vomiting were seen after fluorescein injection.ResultsThe 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).ConclusionsThe 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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