Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery
Condition: Nasal Polyps
MeSH terms: Nasal Polyps
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This study aims to compare two techniques for controlled hypotension during FESS. In both
      cases, the patients will be evaluated during the preoperative anesthetic visit, and will be
      given care by an anesthesiologist during the perioperative period.

      Patients who are scheduled for an elective FESS operation will be included in the study.
      During the preoperative anaesthetic visit, patients who do not meet any of the the exclusion
      criteria will be offered to participate in hte study. Patients accepting to contribute tot he
      study will be randomised into one of the two groups via closed envelope technique.

      A pilot study with 20 patients resulted in similar means and slightly different standard
      deviations of mean blood pressure. This pilot study showed that 44 patients in each group are
      sufficient to obtain 80% power with an alpha error of 0.05 and beta error of 20%. To
      compensate for missing/inconsistent data, or allow for better matching of the demographic
      variables, 3-5 additional patients will be recruited.

      The anesthesiologist in charge of the patient will not be blinded to the groups, and will be
      responsible for maintaining the hypotension (and patient safety) with either remifentanil in
      one group, or tramadol and metoprolol in the other group. Systolic, diastolic, and mean blood
      pressures, and heart rate will be recorded into a spreadsheet every three minutes during the
      anaesthetic and surgical period. The data will be recorded via an excel form, which will
      validate the entries upon entrance. The accuracy and completeness of registry data will be
      verified by a third investigator, who will compare the registry data to the medical monitor
      records at the end of each operative day.

      The surgeon will be blinded to the groups, and will be responsible for scoring the surgical
      vision and bleeding with the intraoperative bleeding score. The study drugs will be
      administered via the same type of infusion pump to facilitate the blinding process.

      Any adverse event will be reported in the patient chart and study records.

      Statistical analysis will be carried out using R and Statistical Package for the Social
      Sciences (SPSS) programs. Demographic variables (age, gender, American Society of
      Anesthesiologists (ASA) score, comorbidities) will be analysed using descriptive statistics.
      Study variables such as duration of operation, variance of the hemodynamic parameters, amount
      of bleeding, bleeding score, occurrence of adverse events will be analysed with the
      appropriate statistical tests.
    

Intervention name(s): Remifentanil; Tramadol; Metoprolol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 0.1 mg/kg of metoprolol will be administered intravenously within 5 minutes following the administration of neuromuscular blocking agent.
Other intervention name(s): Ultiva; Contramal; Beloc
Intervention MeSH terms: Metoprolol; Remifentanil; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug: remifentanil; Drug: tramadol; Drug: metoprolol; Functional endoscopic sinus surgery; Controlled hypotension