Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery

NCT02484859 | Completed Phase 4 Results DMC

• 1 other identifier: 2015/14
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Polyps

Keywords

Drug: remifentanil; Drug: tramadol; Drug: metoprolol; Functional endoscopic sinus surgery; Controlled hypotension

Outcome Measures

Primary Outcomes (1)

• Intraoperative Bleeding Score

  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. 1. Slight bleeding, no suction is required. 2. Slight bleeding, occasional suctioning required. 3. Slight bleeding, frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. 4. Moderate bleeding, frequent suctioning required. Bleeding threatens surgical field as soon as suction is removed. 5. 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.

  throughout surgery, up to 3 hours

Secondary Outcomes (4)

• Time to Achieve Intraoperative Bleeding Score < 3

  throughout surgery, up to 20 minutes

• Bleeding Rate

  throughout surgery, up to 3 hours

• Postoperative Pain

  following extubation, up to 24 hours

• Number of Participants With Postoperative Nausea and Vomiting

  following extubation, up to 24 hours

Study Arms (2)

remifentanil

ACTIVE COMPARATOR

Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. 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.

Drug: Remifentanil

tramadol + metoprolol

ACTIVE COMPARATOR

Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.

Drug: Tramadol; Drug: Metoprolol

Interventions

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.

Also known as: Ultiva

remifentanil

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.

Also known as: Contramal

tramadol + metoprolol

Metoprolol DRUG

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

Also known as: Beloc

tramadol + metoprolol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of rhinosinusitis
• indication for functional endoscopic sinus surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University

Rize, Eastern Blacksea, 53100, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 24403974 BACKGROUND

• 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.

  PMID: 21467830 BACKGROUND

• 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.

  PMID: 19128632 BACKGROUND

• 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.

  PMID: 17991265 BACKGROUND

• 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.

  PMID: 16444651 BACKGROUND

• 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.

  PMID: 16856048 BACKGROUND

• 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.

  PMID: 15816598 BACKGROUND

MeSH Terms

Conditions

Nasal Polyps

Interventions

Remifentanil; Tramadol; Metoprolol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Propanols

Results Point of Contact

• Title: Dr. Başar Erdivanlı
• Organization: Recep Tayyip Erdoğan Üniversitesi

berdivanli@gmail.com

04642130491

Study Officials

• Başar Erdivanlı, Asst. Prof.

  Recep Tayyip Erdogan University, Medical Faculty, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 30, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: December 20, 2023
• Results First Posted: September 10, 2019

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)