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NCT Number: NCT02484859

Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery

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.

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Key information

Conditions

Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Recep Tayyip Erdogan University

Rize, Eastern Blacksea, 53100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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.

Other names: Ultiva

Tramadol

Drug

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.

Other names: Contramal

metoprolol

Drug

0.1 mg/kg of metoprolol will be administered intravenously within 5 minutes following the administration of neuromuscular blocking agent.

Other names: Beloc

Primary outcomes

  1. Intraoperative Bleeding Score

    Time frame: throughout surgery, up to 3 hours

    Intraoperative bleeding score is reported by the surgeon according to Boezaart Surgical Field Grading scale. The scale ranges from 0 to 5. '0' is the best, and '5' is the worst outcome.

    The scale construct is:

    0 No bleeding.

    • Slight bleeding, no suction is required.
    • Slight bleeding, occasional suctioning required.
    • Slight bleeding, frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
    • Moderate bleeding, frequent suctioning required. Bleeding threatens surgical field as soon as suction is removed.
    • Severe bleeding, constant suctioning required. Bleeding appears faster than suctioning.

    Thoroughout the intraoperative period, the surgeon is free to report a score at any time he/she sees appropriate.

Secondary outcomes

  1. Time to Achieve Intraoperative Bleeding Score < 3

    Time frame: throughout surgery, up to 20 minutes

    The intraoperative bleeding score will be reported by the surgeon throughout surgery. At the start of the surgery, a timer will be used to measure the duration to achieve a bleeding score of 2.

  2. Bleeding Rate

    Time frame: throughout surgery, up to 3 hours

    In the end of each surgery, bleeding rate will be calculated as ml/min by dividing total bleeding (amount of blood in the graded suction and sponges minus total irrigation fluid) to the duration of surgery (excluding local anesthetic infiltration, and nasal packing).

  3. Postoperative Pain

    Time frame: following extubation, up to 24 hours

    Postoperative pain scores on the day of surgery will be evaluated with a visual analog scale (0: no pain, 10: worst pain ever) at the post anaesthetic care unit (PACU), and the surgical ward. The evaluation will begin after the patient arrives at the post anaesthetic care unit, and will continue for 24 hours.

  4. Number of Participants With Postoperative Nausea and Vomiting

    Time frame: following extubation, up to 24 hours

    Postoperative nausea, retching, and vomiting on the day of surgery will be evaluated with a four-point ordinal scale (0-none, 1-nausea, 2-retching, 3-vomiting) at the post anaesthetic care unit, and the surgical ward. The evaluation will begin after the patient arrives at the post anaesthetic care unit, and will continue for 24 hours.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Comparison of Normotensive Anesthesia Using a Combination of Metoprolol and Tramadol With Controlled Hypotension Using Remifentanil in Endoscopic Sinus Surgery

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 30, 2015
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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