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NCT Number: NCT06539013

Efficacy of Remifentanil in Preventing Emergence Agitation

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.

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Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hülya Tosun Söner, doctor

CONTACT

[email protected]

+905352792102

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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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.

Treatment and study plan

Remifentanil

Drug

remifentanil infusion

Other names: Use of remifentanil infusion for analgesia

N2O

Drug

Use of N2O for analgesia

Other names: Use of N2O for analgesia

Fentanyl

Drug

Use of Fentanylfor analgesia

Other names: Use of Fentanyl for analgesia

Primary outcomes

  1. Richmond Agitation-Sedation Scale (RASS)

    Time frame: 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 outcomes

  1. mean arterial pressure

    Time frame: Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min

    mmHg

  2. Heart rate

    Time frame: Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min

    beats/min

Study contacts

Contact information is provided by the study sponsor or research team.

Hülya Tosun Söner

CONTACT

[email protected]

+905352792102

Osman Uzundere

CONTACT

[email protected]

+905330206362

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: agitation

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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