The effect of premedication with Valiflore on preoperative anxiety

Phase 2

• Conditions: Anxiety.; Generalized anxiety disorder

• Registration Number: IRCT201404115175N13
• Lead Sponsor: Tehran University of Medical Sciences and Health Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients at the age of 20-55; American Society of Anesthesiologists class I, II; Patients undergoing surgical laparoscopic cholecystectomy.

Exclusion criteria: Patients with a history of anxiety disorders and other mental disorders; Patients with a drug history of sedative drugs; Analgesic; Anti-depressant and anti-seizure; Patients with Numerical Rating Scale for anxiety less than 1.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety. Timepoint: Before administration of premedication, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes after administration of premedication. Method of measurement: Numeric Rating Scale.

Secondary Outcome Measures

Name	Time	Method
Sedation. Timepoint: Before administration of premedication, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes after administration of premedication. Method of measurement: Ramsey Sedation Scale.;Duration of anesthesia. Timepoint: First minute of anesthetia, first minute of recovery. Method of measurement: Time in minute.;Duration of surgery. Timepoint: First minute of starting surgery, minute of finishing surgery. Method of measurement: Time in minute.;Duration of departure time of recovery. Timepoint: First minute of entering recovery, minute of departure of recovery. Method of measurement: Time in minute.