Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04184141

Enrollment

Registered

2019-12-03

Start date

2019-12-01

Completion date

2020-09-01

Last updated

2019-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation on Recovery From Sedation

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.

Interventions

DRUGHydroxyzine Hydrochloride

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

DRUGAlprazolam tablet

Alprozolam is given to the patient one hour before surgery.

DRUGPlacebo

Placebo candy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactOZGUN TOPCUOGLU, MD

ozgntopcuoglu@gmail.com+905318970188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026