Clinical trial

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

Name

2015/14

Description

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.

Trial arms

Trial start

2015-07-01

Estimated PCD

2015-12-01

Trial end

2016-02-01

Status

Completed

Phase

Early phase I

Treatment

Remifentanil

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.

Arms:

remifentanil

Other names:

Ultiva

Tramadol

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.

Arms:

tramadol + metoprolol

Other names:

Contramal

Metoprolol

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

Arms:

tramadol + metoprolol

Other names:

Beloc

Size

Primary endpoint

Intraoperative Bleeding Score

throughout surgery, up to 3 hours

Eligibility criteria

Inclusion Criteria: * diagnosis of rhinosinusitis * indication for functional endoscopic sinus surgery Exclusion Criteria: * American Society of Anesthesiologists risk score \> 2 * undertreated hypertension * Haemoglobin A1c test level \> 7.5 * pregnancy * concurrent surgery * history of drug abuse * history of or new diagnosis of allergy to any of the study drugs * history of post-operative nausea and vomiting

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 88, 'type': 'ACTUAL'}}

Updated at

2023-12-20

1 organization

3 products

1 indication

Organization

Recep Tayyip Erdogan University

Product

Indication

Product

Product