Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction

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.

Study Overview

• Status: Unknown
• Conditions: Agitation on Recovery From Sedation
• Intervention / Treatment: Drug: Alprazolam tablet; Drug: Hydroxyzine Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: OZGUN TOPCUOGLU, MD; Phone Number: +905318970188; Email: ozgntopcuoglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control	Drug: Placebo; Placebo candy
Experimental: alprazolam	Drug: Alprazolam tablet; Alprozolam is given to the patient one hour before surgery.
Experimental: hydroxyzine	Drug: Hydroxyzine Hydrochloride; Hyroxyzine hydrochloride is given to the patient one hour before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preopartive anxiety	Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30)	1 hour later orally admition of drugs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	IOWA pation satisfaction scale (between 9-54)	24 hours after surgery

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: November 30, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Dermatologic Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Alprazolam; Hydroxyzine
• Other Study ID Numbers: 2018-0195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No