Phase 4
Completed N=88
Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery
Source: ClinicalTrials.gov NCT02484859 ↗Enrolled (actual)
88
Serious AEs
23.9%
Results posted
Sep 2019
Primary outcomePrimary: Intraoperative Bleeding Score — 1; 1 units on a scale — p=>0.69
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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
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. Informational only — not medical advice.