Preoperative Use of Alprazolam and Hydroxyzine in Anxiety
The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2019
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedDecember 6, 2019
December 1, 2019
6 months
November 30, 2019
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
preopartive anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30)
1 hour later orally admition of drugs
Secondary Outcomes (1)
Patient satisfaction
24 hours after surgery
Study Arms (3)
alprazolam
EXPERIMENTALhydroxyzine
EXPERIMENTALcontrol
PLACEBO COMPARATORInterventions
Hyroxyzine hydrochloride is given to the patient one hour before surgery.
Eligibility Criteria
You may qualify if:
- sacrococcygeal dermoid cyst patients
- Saceptance of spinal anaesthesia
- between 18-60 years old patients
- ASA I-II
You may not qualify if:
- drug allergy
- BMI\>35kg/m2
- psychiatric disorders
- serious renal and hepatic damage
- coagulation disorders
- serious cardiac and respiratory disorderders
- rejection of spinal anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 30, 2019
First Posted
December 3, 2019
Study Start
December 1, 2019
Primary Completion
June 1, 2020
Study Completion
September 1, 2020
Last Updated
December 6, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share