Clinical trial NCT02484859: Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery
Official title: Comparison of Normotensive Anesthesia Using a Combination of Metoprolol and Tramadol With Controlled Hypotension Using Remifentanil in Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasal Polyps
Keywords: Drug: remifentanil
Drug: tramadol
Drug: metoprolol
Functional endoscopic sinus surgery
Controlled hypotension
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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

Primary outcomes:
measure: Intraoperative Bleeding Score
timeFrame: throughout surgery, up to 3 hours
Secondary outcomes:
measure: Time to Achieve Intraoperative Bleeding Score < 3
timeFrame: throughout surgery, up to 20 minutes
measure: Bleeding Rate
timeFrame: throughout surgery, up to 3 hours
measure: Postoperative Pain
timeFrame: following extubation, up to 24 hours
measure: Number of Participants With Postoperative Nausea and Vomiting
timeFrame: following extubation, up to 24 hours
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
state: Eastern Blacksea
Study officials:
affiliation: Recep Tayyip Erdogan University, Medical Faculty, Department of Anesthesiology
name: Başar Erdivanlı, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hosemann W, Draf C. Danger points, complications and medico-legal aspects in endoscopic sinus surgery. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2013 Dec 13;12:Doc06. doi: 10.3205/cto000098.
citation: Cincikas D, Ivaskevicius J, Martinkenas JL, Balseris S. A role of anesthesiologist in reducing surgical bleeding in endoscopic sinus surgery. Medicina (Kaunas). 2010;46(11):730-4.
citation: Lin D, Dalgorf D, Witterick IJ. Predictors of unexpected hospital admissions after outpatient endoscopic sinus surgery: retrospective review. J Otolaryngol Head Neck Surg. 2008 Jun;37(3):309-11.
citation: Komatsu R, Turan AM, Orhan-Sungur M, McGuire J, Radke OC, Apfel CC. Remifentanil for general anaesthesia: a systematic review. Anaesthesia. 2007 Dec;62(12):1266-80. doi: 10.1111/j.1365-2044.2007.05221.x.
citation: Rathjen T, Bockmuhl U, Greim CA. [Modern anesthesiologic concepts supporting paranasal sinus surgery]. Laryngorhinootologie. 2006 Jan;85(1):20-3. doi: 10.1055/s-2005-870562. German.
citation: Khalil HS, Nunez DA. Functional endoscopic sinus surgery for chronic rhinosinusitis. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004458. doi: 10.1002/14651858.CD004458.pub2.
citation: Sartcaoglu F, Celiker V, Basgul E, Yapakci O, Aypar U. The effect of hypotensive anaesthesia on cognitive functions and recovery at endoscopic sinus surgery. Eur J Anaesthesiol. 2005 Feb;22(2):157-9. doi: 10.1017/s0265021505230284. No abstract available.