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Efficacy of Remifentanil in Preventing Emergence Agitation

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06539013
Acronym
agitation
Enrollment
99
Registered
2024-08-06
Start date
2024-08-01
Completion date
2024-10-01
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation

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.

Interventions

DRUGRemifentanil

remifentanil infusion

DRUGN2O

Use of N2O for analgesia

DRUGFentanyl

Use of Fentanylfor analgesia

Sponsors

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Heart rateBefore induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 minbeats/min
mean arterial pressureBefore induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 minmmHg

Countries

Turkey (Türkiye)

Contacts

Primary ContactHülya Tosun Söner
hulyatosunsoner@hotmail.com+905352792102
Backup ContactOsman Uzundere
osmanuzundere@gmail.com+905330206362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026