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Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

NCT ID: NCT04184141

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Agitation on Recovery From Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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alprazolam

Group Type EXPERIMENTAL

Alprazolam tablet

Intervention Type DRUG

Alprozolam is given to the patient one hour before surgery.

hydroxyzine

Group Type EXPERIMENTAL

Hydroxyzine Hydrochloride

Intervention Type DRUG

Hyroxyzine hydrochloride is given to the patient one hour before surgery.

control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo candy

Interventions

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Hydroxyzine Hydrochloride

Hyroxyzine hydrochloride is given to the patient one hour before surgery.

Intervention Type DRUG

Alprazolam tablet

Alprozolam is given to the patient one hour before surgery.

Intervention Type DRUG

Placebo

Placebo candy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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mesure gul nihan ozden

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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OZGUN TOPCUOGLU, MD

Role: CONTACT

Phone: +905318970188

Email: [email protected]

Other Identifiers

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2018-0195

Identifier Type: -

Identifier Source: org_study_id