Remifentanil and Controlled Hypotension for Functional Endoscopic Sinus Surgery: Comparison With Tramadol and Metoprolol
|Nasal Polyps||Drug: Remifentanil Drug: Tramadol Drug: Metoprolol||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
|Official Title:||Remifentanil and Controlled Hypotension for Functional Endoscopic Sinus Surgery: Comparison With Tramadol and Metoprolol|
- Intraoperative bleeding score [ Time Frame: Participants will be followed up at the first day of surgery ]Intraoperative bleeding score will be determined by the surgeon blinded to the group information at the end of the surgery
- Postoperative pain scores [ Time Frame: Participants will be followed up at the first day of surgery ]Time to first analgesic request, and total analgesic consumption during the first 24 postoperative hours. Participants' pain scores will be measured at the postoperative recovery room, and every 2 hours using a visual analogue scale.
- Composite outcome measure: variation of intraoperative blood pressure [ Time Frame: Participants will be followed up at the first day of surgery ]Intraoperatively, the systolic blood pressure will be maintained below 90 mmHg, and heart rate below 60 per minute
- Composite outcome measure: variation of intraoperative heart rate [ Time Frame: Participants will be followed up at the first day of surgery ]Intraoperatively, the systolic blood pressure will be maintained below 90 mmHg, and heart rate below 60 per minute
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Active Comparator: remifentanil
i.v. infusion of remifentanil at a rate of 0.25-0.5 µg/kg, followed by an i.v. bolus of 0.5 µg/kg
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 infusion will be lowered to 0.05 µg/kg/min, and continued until the patient is extubated.
Other Name: Ultiva
Active Comparator: tramadol + metoprolol
1 mg/kg of tramadol in 100 ml isotonic fluid administered i.v. within the first 30 minutes of the surgery (infusion will be started just before the induction), 5 mg of i.v. metoprolol administered in 2 minutes (after the administration of the neuromuscular blocking agent)
1 mg/kg tramadol will be added to 100 ml of isotonic fluid, and will be administered intravenously in exactly 30 minutes via pump. The infusion will be started just before the induction.
Other Name: ContramalDrug: Metoprolol
5 mg of metoprolol will be administered intravenously in 2 minutes after the administration of neuromuscular blocking agent (rocuronium).
Other Name: Beloc
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 SPSS (Statistical Package for the Social Sciences) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02484859
|Contact: Başar Erdivanlı, Asst. Prof.||04642130491 ext email@example.com|
|Contact: Özlem Çelebi Erdivanlı, Asst. Prof.||04642130491 ext firstname.lastname@example.org|
|Recep Tayyip Erdogan University||Recruiting|
|Rize, Eastern Blacksea, Turkey, 53100|
|Contact: Başar Erdivanlı, Asst 04642130491 ext 2128 email@example.com|
|Contact: Özlem Çelebi Erdivanlı, Asst 04642130491 ext 1392 firstname.lastname@example.org|
|Principal Investigator:||Başar Erdivanlı, Asst. Prof.||Recep Tayyip Erdogan University, Medical Faculty, Department of Anesthesiology and Reanimation|