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Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

Primary Purpose

Agitation on Recovery From Sedation

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Hydroxyzine Hydrochloride
Alprazolam tablet
Placebo
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation on Recovery From Sedation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    alprazolam

    hydroxyzine

    control

    Arm Description

    Outcomes

    Primary Outcome Measures

    preopartive anxiety
    Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30)

    Secondary Outcome Measures

    Patient satisfaction
    IOWA pation satisfaction scale (between 9-54)

    Full Information

    First Posted
    November 30, 2019
    Last Updated
    December 4, 2019
    Sponsor
    Istanbul Medeniyet University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04184141
    Brief Title
    Preoperative Use of Alprazolam and Hydroxyzine in Anxiety
    Official Title
    The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    June 1, 2020 (Anticipated)
    Study Completion Date
    September 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Medeniyet University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Agitation on Recovery From Sedation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    alprazolam
    Arm Type
    Experimental
    Arm Title
    hydroxyzine
    Arm Type
    Experimental
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxyzine Hydrochloride
    Intervention Description
    Hyroxyzine hydrochloride is given to the patient one hour before surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Alprazolam tablet
    Intervention Description
    Alprozolam is given to the patient one hour before surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo candy
    Primary Outcome Measure Information:
    Title
    preopartive anxiety
    Description
    Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30)
    Time Frame
    1 hour later orally admition of drugs
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    IOWA pation satisfaction scale (between 9-54)
    Time Frame
    24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    OZGUN TOPCUOGLU, MD
    Phone
    +905318970188
    Email
    ozgntopcuoglu@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

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