Phase 4 N=88 Randomized Quadruple-blind Other

Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery

Nasal Polyps

Bottom Line

View on ClinicalTrials.gov: NCT02484859 ↗

Enrolled (actual)

Serious AEs

23.9%

Results posted

Sep 2019

Primary outcome: Primary: Intraoperative Bleeding Score — 1; 1 units on a scale — p=>0.69

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Remifentanil (Drug); Tramadol (Drug); Metoprolol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Recep Tayyip Erdogan University
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Intraoperative Bleeding Score	1; 1	>0.69
SECONDARY Time to Achieve Intraoperative Bleeding Score < 3	8.3; 13.4	<0.001 sig
SECONDARY Bleeding Rate	0.53; 0.45	0.052
SECONDARY Postoperative Pain	3; 3; 4; 4	0.05
SECONDARY Number of Participants With Postoperative Nausea and Vomiting	14; 10	0.47

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02484859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.