Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

Istanbul Medeniyet University

Status and phase: Unknown; Phase 4

Conditions: Agitation on Recovery From Sedation

Treatments: Drug: Placebo; Drug: Alprazolam tablet; Drug: Hydroxyzine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04184141

2018-0195

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

alprazolam

Experimental group

Treatment:

Drug: Alprazolam tablet

hydroxyzine

Experimental group

Treatment:

Drug: Hydroxyzine Hydrochloride

control

Placebo Comparator group

Treatment:

Drug: Placebo