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Efficacy of Remifentanil in Preventing Emergence Agitation

Not Applicable
Recruiting
Conditions
Emergence Agitation
Interventions
Registration Number
NCT06539013
Lead Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
99
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
group 1 RemifentanilyRemifentanilPatients in Group 1 received 0.05-0.2 μg/kg/min IV remifentanil infusion as analgesic.
group 3 FentanlyFentanylIn 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.
group 2 N2ON2ON2O instead of 50% air was applied to patients in Group 2 for intraoperative analgesia.
Primary Outcome Measures
NameTimeMethod
Richmond Agitation-Sedation Scale (RASS)Postoperative care unit 1.second_5. second_15.second

* 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

Secondary Outcome Measures
NameTimeMethod
mean arterial pressureBefore induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min

mmHg

Heart rateBefore induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min

beats/min

Trial Locations

Locations (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

🇹🇷

Diyarbakır, Kayapınar, Turkey

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