Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

Agitation on Recovery From Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04184141
• Other study ID #: 2018-0195
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2019
• Source: Istanbul Medeniyet University
• Contact: OZGUN TOPCUOGLU, MD
• Phone: +905318970188
• Email: ozgntopcuoglu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation on Recovery From Sedation
• Psychomotor Agitation

Intervention

Drug:
• Hydroxyzine Hydrochloride
Hyroxyzine hydrochloride is given to the patient one hour before surgery.
• Alprazolam tablet
Alprozolam is given to the patient one hour before surgery.
• Placebo
Placebo candy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preopartive anxiety	Amsterdam Preoperative Anxiety and Information Scale (APAIS) (between 0-30)	1 hour later orally admition of drugs
Secondary	Patient satisfaction	IOWA pation satisfaction scale (between 9-54)	24 hours after surgery