Efficacy of Remifentanil in Preventing Emergence Agitation

NCT ID: NCT06539013

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2024-10-01

Brief Summary

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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

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Conditions

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Emergence Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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group 1 Remifentanily

Patients in Group 1 received 0.05-0.2 μg/kg/min IV remifentanil infusion as analgesic.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

remifentanil infusion

group 2 N2O

N2O instead of 50% air was applied to patients in Group 2 for intraoperative analgesia.

Group Type ACTIVE_COMPARATOR

N2O

Intervention Type DRUG

Use of N2O for analgesia

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.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Use of Fentanylfor analgesia

Interventions

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Remifentanil

remifentanil infusion

Intervention Type DRUG

N2O

Use of N2O for analgesia

Intervention Type DRUG

Fentanyl

Use of Fentanylfor analgesia

Intervention Type DRUG

Other Intervention Names

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Use of remifentanil infusion for analgesia Use of N2O for analgesia Use of Fentanyl for analgesia

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hülya Tosun Söner

Anesthesiology and Reanimation Spesialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hülya Tosun Söner

Role: CONTACT

+905352792102

Osman Uzundere

Role: CONTACT

+905330206362

Facility Contacts

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Hülya Tosun Söner, doctor

Role: primary

+905352792102

Other Identifiers

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HTosunSONE

Identifier Type: -

Identifier Source: org_study_id

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