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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Başar Erdivanlı, Rize Üniversitesi.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02484859
First Posted: June 30, 2015
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Başar Erdivanlı, Rize Üniversitesi
  Purpose
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 (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 Başar Erdivanlı, 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484859


Contacts
Contact: Başar Erdivanlı, Asst. Prof. 04642130491 ext 2128 basar.erdivanli@erdogan.edu.tr
Contact: Özlem Çelebi Erdivanlı, Asst. Prof. 04642130491 ext 1392 ozlem.celebi@erdogan.edu.tr

Locations
Turkey
Recep Tayyip Erdogan University Recruiting
Rize, Eastern Blacksea, Turkey, 53100
Contact: Başar Erdivanlı, Asst    04642130491 ext 2128    basar.erdivanli@erdogan.edu.tr   
Contact: Özlem Çelebi Erdivanlı, Asst    04642130491 ext 1392    ozlem.celebi@erdogan.edu.tr   
Sponsors and Collaborators
Rize Üniversitesi
Investigators
Principal Investigator: Başar Erdivanlı, Asst. Prof. Recep Tayyip Erdogan University, Medical Faculty, Department of Anesthesiology and Reanimation
  More Information

Publications:
Responsible Party: Başar Erdivanlı, Asst. Prof., Rize Üniversitesi
ClinicalTrials.gov Identifier: NCT02484859     History of Changes
Other Study ID Numbers: 2015/14
First Submitted: June 19, 2015
First Posted: June 30, 2015
Last Update Posted: October 12, 2017
Last Verified: October 2015

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

Additional relevant MeSH terms:
Hypotension
Nasal Polyps
Vascular Diseases
Cardiovascular Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Remifentanil
Tramadol
Metoprolol
Neuromuscular Blocking Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists