OBJECTIVES: Controlling preoperative anxiety (PAN) without increasing post-operative psychomotor dysfunction has been an anesthesia concern especially in ambulatory surgeries; therefore using a strong anxiolytic with minimal psychomotor dysfunction for premedication is very desirable. In this study, it was hypothesized that Passiflora incarnata decreases PAN as much as Oxazepam.
Design: A Double Blind, Placebo Controlled Study.
METHODS: In this double blinded placebo controlled study, 128 patients would be divided into Passiflora group (n=68) receiving oral Passiflora incarnata and oxazepam group (n=60) receiving Oxazepam (10 mg), 90 min before surgery. A numerical rating scale (NRS) would be used for each patient to evaluate patients' anxiety, before, and 90 min after premedication. Psychomotor function would be assessed with Trieger Dot Test (TDT) and Digit-Symbol Substitution Test (DSST) at arrival in operating room, and 90 min after tracheal extubation.
Inclusion criteria: Patients referring to our anesthesia clinic, classified as American Society of Anesthesiologists (ASA) physical status of I or II, aged 18-60, who will be candidated for ambulatory inguinal herniorhaphy.
Exclusion criteria: Patients with a history of anxiety disorders or consuming sedative, analgesic, antidepressant, or anti epileptic drugs; addict patients; patients with numerical rating scale (NRS) of less than one, for anxiety; Patients with any contraindications to the medications of study.
Interrvention: Passiflora incarnata, 500 mg, ( Passipy TM Iran Darouk) orally used 120 min before surgery in one group, and Oxazepam, 10 mg, orally used, 120 min before surgery in another group.
Main outcome variables: Investigation and comparison of anxiety reduction in both groups, evaluating and comparing occurrence of psychomotor disorder between the both groups.
Design: A Double Blind, Placebo Controlled Study.
METHODS: In this double blinded placebo controlled study, 128 patients will randomize into Passiflora group (n=68) receiving oral Passiflora incarnata and oxazepam group (n=60) receiving oxazepam (10 mg), 90 min before surgery. A numerical rating scale (NRS) will be used for each patient to assess patients' anxiety, before, and 90 min following premedication. Psychomotor function will be assessed with Trieger Dot Test (TDT) and Digit-Symbol Substitution Test (DSST) at arrival in operating room, and 90 min after tracheal extubation.
Inclusion criteria: Patients referring to our anesthesia clinic, classified as American Society of Anesthesiologists (ASA) physical status of I or II, aged 18-60, who will be candidated for ambulatory inguinal herniorhaphy.
Exclusion criteria: Patients with a history of anxiety disorders or consuming sedative, analgesic, antidepressant, or antiepileptic drugs; addict patients; patients with numerical rating scale (NRS) of less than one, for anxiety; Patients with any contraindications to the medications of study.
Interrvention: Passiflora incarnata, 500 mg, ( PassipyTM IranDarouk) orally 120 min before surgery in one group, Oxazepam, 10 mg, orally, 120 min before surgery in another group.