Preoperative Oral Valiflore Reduces Anxiety in Laparoscopic Cholecystectomy: a Double Blind, Placebo Controlled Study

Background: Many patients undergoing surgical procedures experience preoperative anxiety. Therefore; develop a drug as a premedication with strong anxiolytic effect and minimal psychomotor impairment is desirable. Materials and Methods: Under ethics committee approval, eighty patients, who met the inclusion criteria, were randomly assigned to two groups to receive either oral Valiflore (600 mg, Niak) or placebo as a premedication, 90 minutes before surgery. A numerical rating scale (NRS) for anxiety and the Ramsay sedation scale were measured at baseline, and 15, 30, 60, 90 minutes after premedication. Psychomotor function recovery was assessed using the Digit Symbol Substitution Test and the Trieger Dot Test on arrival in the operating room, 30 and 90 minutes after tracheal extubation. The duration of anesthesia, surgery and recovery time were recorded for each patient. Results: There were no significant differences in the patients’ demographic characteristics, ASA physical status, basal NRS score, the sedation level at different time intervals, duration of anesthesia, surgery and recovery time in the two groups (p>0.05). The NRS anxiety scores were significantly lower in the Valiflore group in comparison with the control group (p<0.001). There was no significant difference in psychomotor function test in both groups. Conclusion: Oral administration of Valiflore as a premedication reduces anxiety before surgery without inducing sedation.