CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 88 enrolled
Drug / intervention
Remifentanil +2 moredrug
Likely dose
Remifentanil 0.5 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02484859
NCT02484859Phase 4Completed

Comparison of Normotensive Anesthesia Using a Combination of Metoprolol and Tramadol With Controlled Hypotension Using Remifentanil in Endoscopic Sinus Surgery

Recep Tayyip Erdogan University·interventional·Posted Jun 30, 2015·Updated Dec 20, 2023

In Brief

A Phase 4 clinical trial evaluating Remifentanil, Tramadol, and 1 other intervention for Nasal Polyps. Completed, enrolled 88 participants across 1 site.

Detailed Summary

Functional endoscopic sinus surgery (FESS) is indicated in diseases such as chronic sinusitis refractory to medical treatment, nasal polyposis, mass lesions in the nasal cavity. The purpose of this study is to determine whether tramadol and metoprolol are as effective as remifentanil in providing controlled hypotension during FESS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Polyps
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 30, 2015
Enrollment StartJul 1, 2015
Primary CompletionDec 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.0 years ago

Interventions

Remifentanildrug

Remifentanil infusion will be started with a bolus dose of 0.5 µg/kg before the induction, and will be continued throughout the surgery at a dose of 0.25-0.5 µg/kg/min. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.

Tramadoldrug

1 mg/kg tramadol will be added to 100 ml of isotonic fluid, and will be administered intravenously in exactly 30 minutes via a perfusor. The infusion will be started just before the induction.

Metoprololdrug

0.1 mg/kg of metoprolol will be administered intravenously within 5 minutes following the administration of neuromuscular blocking agent.