Effects of Preoperative Anxiety and Pre… | Clinical Trial

Key information

Conditions

Preoperative Anxiety Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-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

Treatment and study plan

The Beck Anxiety Inventory (BAI) of adult patients

Other

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

Other names: 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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jun 8, 2025
Registry last updated: Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed