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Efficacy of Remifentanil in Preventing Emergence Agitation (agitation)

S

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status

Enrolling

Conditions

Emergence Agitation

Treatments

Drug: Remifentanil
Drug: Fentanyl
Drug: N2O

Study type

Interventional

Funder types

Other

Identifiers

NCT06539013
HTosunSONE

Details and patient eligibility

About

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.

Enrollment

99 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

99 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Hülya Tosun Söner; Osman Uzundere

Data sourced from clinicaltrials.gov

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