Efficacy of Remifentanil in Preventing Emergence Agitation (agitation)

Efficacy of Remifentanil in Preventing Emergence Agitation in Patients Undergoing Nasal Surgery Under Desflurane Anesthesia: A Prospective Double-blind Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Remifentanil; Drug: N2O; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hülya tosun söner; Phone Number: +905352792102; Email: hulyatosunsoner@hotmail.com
• Study Contact Backup: Name: osman Uzundere; Phone Number: +905330206362; Email: osmanuzundere@gmail.com

Study Locations

• Turkey
  • Kayapınar
    • Diyarbakır, Kayapınar, Turkey, 21070
      • Recruiting
      • Health Sciences University Gazi Yaşargil Training and Research Hospital
      • Contact: Hülya Tosun Söner, doctor; Phone Number: +905352792102; Email: hulyatosunsoner@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

-

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1 Remifentanily; Patients in Group 1 received 0.05-0.2 μg/kg/min IV remifentanil infusion as analgesic.	Drug: Remifentanil; remifentanil infusion; Other Names: Use of remifentanil infusion for analgesia
Active Comparator: group 2 N2O; N2O instead of 50% air was applied to patients in Group 2 for intraoperative analgesia.	Drug: N2O; Use of N2O for analgesia; Other Names: Use of N2O for analgesia
Active Comparator: group 3 Fentanly; 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; Use of Fentanylfor analgesia; Other Names: Use of Fentanyl for analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 calm1 Awakens to voice (eye opening/contact) > 10 seconds2 Light sedation; briefly awakens to voice (eye opening/contant) < 10 seconds3 Moderate sedation; movement or eye opening. No eye contact4 Deep sedation; no response to voice, but movement or eye opening to physical stimulation5 Unarousable; no response to voice or physical stimulation	Postoperative care unit 1.second_5. second_15.second

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial pressure	mmHg	Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min
Heart rate	beats/min	Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Aberrant Motor Behavior in Dementia; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Fentanyl
• Other Study ID Numbers: HTosunSONE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No