Total Intravenous Anesthesia (TIVA) vs. Inhaled Anesthesia for Endoscopic Sinus Surgery.

NCT01214057 | Terminated Results DMC

• 1 other identifier: HSC-MS-10-0014
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare total intravenous anesthesia to inhaled anesthesia in endoscopic sinus surgery for chronic sinusitis. The investigators will compare bleeding during surgery, duration of surgery, blood flow to the nose and other parameters. The investigators hypothesize that total intravenous anesthesia decreases bleeding and improves the view during surgery.

Conditions

Chronic Rhinosinusitis

Keywords

chronic rhinosinusitis; endoscopic sinus surgery; TIVA; surgical field visualization

Outcome Measures

Primary Outcomes (6)

• Volume of Blood Loss

  Blood loss was determined by subtracting the volume of irrigation used intraoperatively from the total volume of fluid in the collection canisters.The Neptune Waste Management System will be used for this purpose. This is a closed suction system that digitally counts the amount of fluid suctioned.

  during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)

• Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised

  Surgeons rated the surgical field using the Boezaart score (which ranges from 0 to 5, with 5 indicating the most compromised surgical field), and this outcome measure reports the number of participants with a Boezaart score of 5. Boezaart scoring is as follows: 0 (No bleeding, cadaveric conditions); 1 (Slight bleeding, no suctioning 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, and bleeding threatens surgical field directly after suction is removed); 5 (Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible).

  during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)

• Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)

  Thromboelastography-Platelet Mapping will be performed to assess the effect of the anesthetics on platelet function. Data are reported as Maximum Amplitude (MA) in millimeters (mm). A greater MA value indicates stronger clotting and greater platelet function.

  baseline

• Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)

  Thromboelastography-Platelet Mapping will be performed to assess the effect of the anesthetics on platelet function. Data are reported as Maximum Amplitude (MA) in millimeters (mm). A greater MA value indicates stronger clotting and greater platelet function.

  During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)

• Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System

  The Rhinolux system was used to measure nasal blood flow (it assessed changes in the swelling of the nasal mucosa by a tissue light absorption technique similar to that used in pulse oximetry)--more negative optical density unit values indicate greater nasal blood flow and less light.

  0-5 minutes after induction of anesthesia

• Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System

  The Rhinolux system was used to measure nasal blood flow (it assessed changes in the swelling of the nasal mucosa by a tissue light absorption technique similar to that used in pulse oximetry)--negative values indicate greater nasal blood flow and less light.

  60-90 minutes after induction of anesthesia

Secondary Outcomes (5)

• Duration of Surgery

  during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)

• Quality of Recovery as Indicated by Pain Rating Using a Visual Analogue Scale (VAS)

  During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)

• Quality of Recovery as Indicated by Number of Participants With Nausea

  During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)

• Quality of Recovery as Indicated by Recovery Time in the PACU

  During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)

• Quality of Recovery as Indicated by Number of Participants Who Received an Analgesic Post-operatively

  During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)

Study Arms (2)

Total Intravenous Anesthesia

EXPERIMENTAL

Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl

Drug: Propofol and Remifentanyl

Inhaled Anesthesia

ACTIVE COMPARATOR

Inhaled anesthesia with sevoflurane and remifentanyl.

Drug: Sevoflurane and Remifentanyl

Interventions

Propofol and Remifentanyl DRUG

Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.

Also known as: Propofol brand name is Diprivan, Remifentanyl brand name is Ultiva

Total Intravenous Anesthesia

Sevoflurane and Remifentanyl DRUG

Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.

Also known as: Remifentanyl brand name is Ultiva, Sevoflurane brand name is Ultane and Sojourn

Inhaled Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of chronic rhinosinusitis
• Indication by the surgeon of need for endoscopic sinus surgery

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital - Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Propofol; Remifentanil; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Davide Cattano, MD
• Organization: The University of Texas Health Science Center at Houston

Davide.Cattano@uth.tmc.edu

(713) 500-6200

Study Officials

• Davide Cattano, MD PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Anesthesiology

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: October 4, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 1, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-10

Locations

US (1)