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

NCT07010042 | Completed

• 1 other identifier: 2020Septo/Rhinoplasty Surgery
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preoperative Anxiety; Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During the first 15 minutes postoperatively

Study Arms (2)

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

The Beck Anxiety Inventory (BAI) of adult patients OTHER

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.

Group K:n:43 patients; Group P: n: 43patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

86

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Bays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oceans and Seas; Geological Phenomena; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 8, 2025
• Study Start: March 15, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

TU (1)