Preoperative AnxietyNCT07010042
Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
An observational study of Preoperative Anxiety and Postoperative Delirium, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Preoperative Anxiety, Postoperative Delirium
- What is being tested?
- The Beck Anxiety Inventory (BAI) of adult patients
- Type of treatment
- Injection or infusion
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 Sep 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: 86
Who may be able to join
- - 18-65 years old,
- ASA I-II risk group
- Those who will be operated under general anesthesia under elective conditions.
- Will undergo surgery for Septo/Rhinoplasty
- Patients whose informed consent form was read to their parents was obtained
Who cannot join
- -Those do not want to participate in the study,
- ASA III -IV-V patients
- Having a history of drug allergy and drug interaction,
- Having a history of systemic disease such as heart, kidney, liver failure,
- Having a history of bleeding diathesis,
- Difficult intubation expected,
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- Obese,
- Emergency patients,
- Mental-motor retarded,
- Having psychiatric and neurological diseases,
- Those with chronic drug use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, Kozlu, 67600
About this study
Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
Read the detailed description
It is known that preoperative anxiety causes postoperative agitation.
In adult patients, preoperative anxiety is assessed with the Beck Anxiety Inventory (BAI) and BAI≥16 is considered 'anxious'. Postoperative agitation is assessed with the Riker Sedation-Agitation Scale (RSAS) and RSAS ≥5 is considered agitated, pain is assessed with the Numerical Pain Scale (NRS) >4 is considered postoperative pain. Measurements were recorded at 0, 5, 10 and 15 minutes postoperatively.
There are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.
- Conditions
- Preoperative Anxiety, Postoperative Delirium
- Being tested
- The Beck Anxiety Inventory (BAI) of adult patients
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Beck Anxiety Inventory (BAI) of adult patientsOther
Also called Postoperative agitation in adult patients is assessed with the Riker Sedation-Agitation Scale (RSAS)., The Numerical Pain Scale (NRS) is used to evaluate postoperative pain in adult patients.
Postoperative 0,5,10,15 minutes , RSAS and NRS values
| Study group | Role | What they receive |
|---|---|---|
| Group P: n: 43patients | Group P: Patients administered iv 1 gr paracetamol 30 minutes before surgery Receives: Other: The Beck Anxiety Inventory (BAI) of adult patients | |
| Group K:n:43 patients | Group K: Patients administered iv 1 gr paracetamol 15 minutes before the end of surgery Receives: Other: The Beck Anxiety Inventory (BAI) of adult patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
The correlation between the BAI values of the groups and the RSAS scores and NRS values Beck Anxiety Scale Scoring 8-15 points are categorized as mild anxiety symptoms, 2. 16-25 points are moderate anxiety symptoms, 3. 26-63 points are severe anxiety symptoms.
Riker Sedation-Agitation Scale:
7-Dangerous agitation 6-Very agitated 5-Agitated 4-Calm and cooperative 3-Sedated 2-Very sedated
1-Unarousable Numerical Rating Scale Scores range from 0-10, with higher scores indicating greater pain intensity.
Measured: During the first 15 minutes postoperatively
Preemptive Analgesia for Postoperative Agitation in Septo/Rhinoplasty Surgery
The relationship between the BAI values of the groups and the RSAS scores and NRS The correlation between the BAI values of the groups and the RSAS scores and NRS values Beck Anxiety Scale Scoring 8-15 points are categorized as mild anxiety symptoms, 2. 16-25 points are moderate anxiety symptoms, 3. 26-63 points are severe anxiety symptoms. Riker Sedation-Agitation Scale: 7-Dangerous agitation 6-Very agitated 5-Agitated 4-Calm and cooperative 3-Sedated 2-Very sedated 1-Unarousable Numerical Rating Scale Scores range from 0-10, with higher scores indicating greater pain intensity.
Measured: During the first 15 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start15 Mar 2020
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Küçükosman, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010042
- Sponsor's protocol ID
- 2020Septo/Rhinoplasty Surgery
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
- ClinicalTrials.gov ID
- NCT07010042
- Acronym / sponsor ID
- 2020Septo/Rhinoplasty Surgery
- Conditions
- Preoperative Anxiety, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 8 Jun 2025 (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.
Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
Detailed description
It is known that preoperative anxiety causes postoperative agitation.
In adult patients, preoperative anxiety is assessed with the Beck Anxiety Inventory (BAI) and BAI≥16 is considered 'anxious'. Postoperative agitation is assessed with the Riker Sedation-Agitation Scale (RSAS) and RSAS ≥5 is considered agitated, pain is assessed with the Numerical Pain Scale (NRS) >4 is considered postoperative pain. Measurements were recorded at 0, 5, 10 and 15 minutes postoperatively.
There are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P: n: 43patients | – | Other: The Beck Anxiety Inventory (BAI) of adult patientsGroup P: Patients administered iv 1 gr paracetamol 30 minutes before surgery |
| Group K:n:43 patients | – | Other: The Beck Anxiety Inventory (BAI) of adult patientsGroup K: Patients administered iv 1 gr paracetamol 15 minutes before the end of surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 86
Key inclusion criteria (5 listed)
- - 18-65 years old,
- ASA I-II risk group
- Those who will be operated under general anesthesia under elective conditions.
- Will undergo surgery for Septo/Rhinoplasty
- Patients whose informed consent form was read to their parents was obtained
Key exclusion criteria (11 listed)
- -Those do not want to participate in the study,
- ASA III -IV-V patients
- Having a history of drug allergy and drug interaction,
- Having a history of systemic disease such as heart, kidney, liver failure,
- Having a history of bleeding diathesis,
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 |
|---|---|---|
| The Beck Anxiety Inventory (BAI) of adult patientsAlso: Postoperative agitation in adult patients is assessed with the Riker Sedation-Agitation Scale (RSAS)., The Numerical Pain Scale (NRS) is used to evaluate postoperative pain in adult patients.Postoperative 0,5,10,15 minutes , RSAS and NRS values | Other | Group K:n:43 patients, Group P: n: 43patients |
Primary outcome
Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery
Time frame: During the first 15 minutes postoperatively
The correlation between the BAI values of the groups and the RSAS scores and NRS values Beck Anxiety Scale Scoring 8-15 points are categorized as mild anxiety symptoms, 2. 16-25 points are moderate anxiety symptoms, 3. 26-63 points are severe anxiety symptoms. Riker Sedation-Agitation Scale: 7-Dangerous agitation 6-Very agitated 5-Agitated 4-Calm and cooperative 3-Sedated 2-Very sedated 1-Unarousable Numerical Rating Scale Scores range from 0-10, with higher scores indicating greater pain intensity.
Preemptive Analgesia for Postoperative Agitation in Septo/Rhinoplasty Surgery
Time frame: During the first 15 minutes postoperatively
The relationship between the BAI values of the groups and the RSAS scores and NRS The correlation between the BAI values of the groups and the RSAS scores and NRS values Beck Anxiety Scale Scoring 8-15 points are categorized as mild anxiety symptoms, 2. 16-25 points are moderate anxiety symptoms, 3. 26-63 points are severe anxiety symptoms. Riker Sedation-Agitation Scale: 7-Dangerous agitation 6-Very agitated 5-Agitated 4-Calm and cooperative 3-Sedated 2-Very sedated 1-Unarousable Numerical Rating Scale Scores range from 0-10, with higher scores indicating greater pain intensity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Anxiety and Postoperative Delirium, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery (time frame: During the first 15 minutes postoperatively). The study lists 2 primary outcomes in all. 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 8 Jun 2025.