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CompletedNCT07010042Updated Jun 8, 2025

Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Septo/Rhinoplasty Surgery

An observational study in Preoperative Anxiety and Postoperative Delirium, sponsored by Zonguldak Bulent Ecevit University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-08.

Sponsored by Zonguldak Bulent Ecevit University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
86
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Preoperative Anxiety
  • Postoperative Delirium
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 86 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Zonguldak Bulent Ecevit University is the lead sponsor of 96 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

86

Inclusion criteria

    • 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

Exclusion criteria

Exclusion Criteria:

  • -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,
  • Obese,
  • Emergency patients,
  • Mental-motor retarded,
  • Having psychiatric and neurological diseases,
  • Those with chronic drug use
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
86 participants (actual)
Patient registry
No

Groups and cohorts

  • Group P: n: 43patients

    Group P: Patients administered iv 1 gr paracetamol 30 minutes before surgery

    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

    Other: The Beck Anxiety Inventory (BAI) of adult patients

Interventions

  • OtherThe Beck Anxiety Inventory (BAI) of adult patients

    Postoperative 0,5,10,15 minutes , RSAS and NRS values

    Also known as: 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the first 15 minutes postoperatively

  2. 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.

    Time frame: During the first 15 minutes postoperatively

07

Study locations

1 site
  • Zonguldak Bülent Ecevit University
    Zonguldak, Kozlu 67600, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07010042
Lead sponsor
Zonguldak Bulent Ecevit University
Responsible party
Gamze Küçükosman (medical doctor, Zonguldak Bulent Ecevit University) — Principal investigator
First posted
Jun 8, 2025
Start date
Mar 15, 2020
Primary completion
Sep 15, 2020
Completion
Sep 15, 2020
Last update
Jun 8, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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