Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

Phase 4

• Conditions: Agitation on Recovery From Sedation
• Interventions: Drug: Placebo; Drug: Hydroxyzine Hydrochloride; Drug: Alprazolam tablet

• Registration Number: NCT04184141
• Lead Sponsor: Istanbul Medeniyet University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-30
• Status Verified: 2019-12
• Study Start: 2019-12-01
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06
• Primary Completion: 2020-06-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Placebo	-
hydroxyzine	Hydroxyzine Hydrochloride	-
alprazolam	Alprazolam tablet	-

Primary Outcome Measures

Name	Time	Method
preopartive anxiety	1 hour later orally admition of drugs	Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30)

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	24 hours after surgery	IOWA pation satisfaction scale (between 9-54)