Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Remifentanil and Controlled Hypotension for Functional Endoscopic Sinus Surgery: Comparison With Tramadol and Metoprolol

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Rize Üniversitesi
Information provided by (Responsible Party):
Başar Erdivanlı, Rize Üniversitesi Identifier:
First received: June 19, 2015
Last updated: October 25, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Nasal Polyps
Drug: Remifentanil
Drug: Tramadol
Drug: Metoprolol
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Rize Üniversitesi:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 90
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)
Arms Assigned Interventions
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
Drug: Remifentanil
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)
Drug: Tramadol
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: Contramal
Drug: Metoprolol
5 mg of metoprolol will be administered intravenously in 2 minutes after the administration of neuromuscular blocking agent (rocuronium).
Other Name: Beloc

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 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.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • diagnosis of rhinosinusitis
  • indication for functional endoscopic sinus surgery

Exclusion Criteria:

  • American Society of Anesthesiologists risk score > 2
  • undertreated hypertension
  • HgA1C (hemoglobin 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02484859

Contact: Başar Erdivanlı, Asst. Prof. 04642130491 ext 2128
Contact: Özlem Çelebi Erdivanlı, Asst. Prof. 04642130491 ext 1392

Recep Tayyip Erdogan University Recruiting
Rize, Eastern Blacksea, Turkey, 53100
Contact: Başar Erdivanlı, Asst    04642130491 ext 2128   
Contact: Özlem Çelebi Erdivanlı, Asst    04642130491 ext 1392   
Sponsors and Collaborators
Rize Üniversitesi
Principal Investigator: Başar Erdivanlı, Asst. Prof. Recep Tayyip Erdogan University, Medical Faculty, Department of Anesthesiology and Reanimation
  More Information

Responsible Party: Başar Erdivanlı, Asst. Prof., Rize Üniversitesi Identifier: NCT02484859     History of Changes
Other Study ID Numbers: 2015/14
Study First Received: June 19, 2015
Last Updated: October 25, 2015

Keywords provided by Rize Üniversitesi:
Drug: remifentanil
Drug: tramadol
Drug: metoprolol
Functional endoscopic sinus surgery
Controlled hypotension

Additional relevant MeSH terms:
Nasal Polyps
Vascular Diseases
Cardiovascular Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Neuromuscular Blocking Agents
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Neuromuscular Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Adrenergic beta-1 Receptor Antagonists processed this record on May 25, 2017