Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

Overview

Patients will be divided into three groups. Group H patients will be given 100 mg Hydroxyzine orally 1 hour before surgery while group A patients will receive 0.5 mg Alprazolam orally. group P will be placebo group. Amsterdam Preoperative Anxiety and Knowledge Scale (APAIS) anxiety scores will be evaluated and recorded 1 hour before surgery. APAIS score will be evaluated again in the the operation room before surgery started. After base measurements of patients are recorded with standard monitoring, spinal block will be performed with 15 mg Heavy Bupivacaine from the L2-L3 or L3-L4 levels of spinal cord in sting position. When T10 level sensory block and Bromage 0-1 neuromusculer block will be occured , surgery will be started. Heart rate, non-invasive arterial blood pressure and the degree of peripheral O2 saturation will be measured at 5 minutes interval throughout the operation. IOWA anesthesia satisfaction scale will also performed to the patients the day after the surgery.

Full Title of Study: “The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: June 1, 2020

Interventions

  • Drug: Hydroxyzine Hydrochloride
    • Hyroxyzine hydrochloride is given to the patient one hour before surgery.
  • Drug: Alprazolam tablet
    • Alprozolam is given to the patient one hour before surgery.
  • Drug: Placebo
    • Placebo candy

Arms, Groups and Cohorts

  • Experimental: alprazolam
  • Experimental: hydroxyzine
  • Placebo Comparator: control

Clinical Trial Outcome Measures

Primary Measures

  • preopartive anxiety
    • Time Frame: 1 hour later orally admition of drugs
    • Amsterdam Preoperative Anxiety and Information Scale (APA─░S) (between 0-30)

Secondary Measures

  • Patient satisfaction
    • Time Frame: 24 hours after surgery
    • IOWA pation satisfaction scale (between 9-54)

Participating in This Clinical Trial

Inclusion Criteria

  • sacrococcygeal dermoid cyst patients – Saceptance of spinal anaesthesia – between 18-60 years old patients – ASA I-II Exclusion Criteria:
  • drug allergy – BMI>35kg/m2 – psychiatric disorders – serious renal and hepatic damage – coagulation disorders – serious cardiac and respiratory disorderders – rejection of spinal anesthesia
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 60 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Istanbul Medeniyet University
    • Provider of Information About this Clinical Study
      • Principal Investigator: mesure gul nihan ozden, Principal investigator – Istanbul Medeniyet University
    • Overall Contact(s)
      • OZGUN TOPCUOGLU, MD, +905318970188, ozgntopcuoglu@gmail.com

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