Efficacy of Remifentanil in Preventing Emergence Agitation

NCT06539013 | Recruiting

• 1 other identifier: HTosunSONE
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study was to test the hypothesis that remifentanil administered for analgesia prevents emergence agitation more effectively than fentanyl and N2O in patients undergoing rhinoplasty who received desflurane as an inhaled anesthetic agent. The secondary aim of the study was to compare the demographic data, intraoperative and postoperative hemodynamic data, surgical time and modified Aldrete score of patients who received different intraoperative analgesia methods.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• Richmond Agitation-Sedation Scale (RASS)

  * 4 Combative, violent, danger to staff * 3 Pulls or removes tube(s) or catheters; aggressive * 2 Frequent non-purposeful movement, fights ventilator * 1 Anxious, apprehensive, but not aggressive 0 Alert and calm * 1 Awakens to voice (eye opening/contact) \> 10 seconds * 2 Light sedation; briefly awakens to voice (eye opening/contant) \< 10 seconds * 3 Moderate sedation; movement or eye opening. No eye contact * 4 Deep sedation; no response to voice, but movement or eye opening to physical stimulation * 5 Unarousable; no response to voice or physical stimulation

  Postoperative care unit 1.second_5. second_15.second

Secondary Outcomes (2)

• mean arterial pressure

  Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min

• Heart rate

  Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min

Study Arms (3)

group 1 Remifentanily

ACTIVE COMPARATOR

Patients in Group 1 received 0.05-0.2 μg/kg/min IV remifentanil infusion as analgesic.

Drug: Remifentanil

group 2 N2O

ACTIVE COMPARATOR

N2O instead of 50% air was applied to patients in Group 2 for intraoperative analgesia.

Drug: N2O

group 3 Fentanly

ACTIVE COMPARATOR

In addition to Desflurane, 50% oxygen and 50% air, 1 μg/kg IV fentanyl bolus was administered as analgesic when there was a 20% increase in heart rate and blood pressure values during the operation for patients in Group 3.

Drug: Fentanyl

Interventions

Remifentanil DRUG

remifentanil infusion

Also known as: Use of remifentanil infusion for analgesia

group 1 Remifentanily

N2O DRUG

Use of N2O for analgesia

Also known as: Use of N2O for analgesia

group 2 N2O

Fentanyl DRUG

Use of Fentanylfor analgesia

Also known as: Use of Fentanyl for analgesia

group 3 Fentanly

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study included patients over the age of 18, planned to undergo rhinoplasty by the plastic and reconstructive surgery department, and American Society of Anesthesiologist (ASA) I-II.

You may not qualify if:

• Patients with a known history of allergy to the drugs to be administered in the study, ASA III and above, body mass index (BMI) 35\>kg/m2, younger than 18 years of age, any problems that would prevent general anesthesia in the preoperative evaluation (upper respiratory tract infection, etc.), and those who did not agree to participate in the study were excluded from the study.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Remifentanil; Analgesia; Fentanyl

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)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia and Analgesia

Central Study Contacts

Hülya Tosun Söner

CONTACT

+905352792102; hulyatosunsoner@hotmail.com

Osman Uzundere

CONTACT

+905330206362; osmanuzundere@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Spesialist

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: August 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

TU (1)