Agitation on Recovery From SedationPhase 4NCT04184141
Preoperative Use of Alprazolam and Hydroxyzine in Anxiety
A Phase 4 study testing Hydroxyzine Hydrochloride and Alprazolam tablet in people with Agitation on Recovery From Sedation, run by Istanbul Medeniyet University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Agitation on Recovery From Sedation
- What is being tested?
- Hydroxyzine Hydrochloride and Alprazolam tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- sacrococcygeal dermoid cyst patients
- Saceptance of spinal anaesthesia
- between 18-60 years old patients
- ASA I-II
Who cannot join
- drug allergy
- BMI>35kg/m2
- psychiatric disorders
- serious renal and hepatic damage
- coagulation disorders
- serious cardiac and respiratory disorderders
- rejection of spinal anesthesia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction
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.
- Conditions
- Agitation on Recovery From Sedation
- Being tested
- Hydroxyzine Hydrochloride, Alprazolam tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyzine HydrochlorideDrug
Hyroxyzine hydrochloride is given to the patient one hour before surgery.
Alprazolam tabletDrug
Alprozolam is given to the patient one hour before surgery.
PlaceboDrug
Placebo candy
| Study group | Role | What they receive |
|---|---|---|
| alprazolam | Experimental | Not described Receives: Drug: Alprazolam tablet |
| hydroxyzine | Experimental | Not described Receives: Drug: Hydroxyzine Hydrochloride |
| control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
preopartive anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30)
Measured: 1 hour later orally admition of drugs
Secondary outcomes (1)
Patient satisfaction
IOWA pation satisfaction scale (between 9-54)
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation on Recovery From SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mesure gul nihan ozden, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184141
- Sponsor's protocol ID
- 2018-0195
- Status last verified
- Dec 2019
- First submitted
- 30 Nov 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT04184141
- Acronym / sponsor ID
- 2018-0195
- Conditions
- Agitation on Recovery From Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alprazolam | Experimental | Drug: Alprazolam tablet |
| hydroxyzine | Experimental | Drug: Hydroxyzine Hydrochloride |
| control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- sacrococcygeal dermoid cyst patients
- Saceptance of spinal anaesthesia
- between 18-60 years old patients
- ASA I-II
Key exclusion criteria (7 listed)
- drug allergy
- BMI>35kg/m2
- psychiatric disorders
- serious renal and hepatic damage
- coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyzine HydrochlorideHyroxyzine hydrochloride is given to the patient one hour before surgery. | Drug | hydroxyzine |
| Alprazolam tabletAlprozolam is given to the patient one hour before surgery. | Drug | alprazolam |
| PlaceboPlacebo candy | Drug | control |
Primary outcome
preopartive anxiety
Time frame: 1 hour later orally admition of drugs
Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30)
1 secondary outcome
Patient satisfaction
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxyzine Hydrochloride and Alprazolam tablet in people with Agitation on Recovery From Sedation, run by Istanbul Medeniyet University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OZGUN TOPCUOGLU, MD (+905318970188, ozgntopcuoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preopartive anxiety (time frame: 1 hour later orally admition of drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.