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

This study has been terminated.
(the study was terminated for patient recruitment difficulty and interim power analysis)
Sponsor:
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01214057
First received: August 4, 2010
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Chronic Rhinosinusitis.
Drug: Propofol and Remifentanyl
Drug: Sevoflurane and Remifentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Preliminary Study to Assess the Effects of Total Intravenous Anesthesia With Propofol/Remifentanyl Compared to Sevoflurane/Remifentanyl for Endoscopic Sinus Surgery: Novel Approach.

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Bleeding [ Time Frame: upto 1 day ] [ Designated as safety issue: Yes ]
    Blood loss will be measured by counting the volume in the collection canisters and substracting the volume of irrigation used intraoperatively. 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.

  • Surgical Field Visualization [ Time Frame: upto 1 day ] [ Designated as safety issue: Yes ]
    The surgical grade score will be based on the Boezaart surgical risk assessment score. This is an inexpensive, reliable, and sensitive tool to rapidly evaluate intraoperative bleeding in ESS. The score of the operative field will be compared between the groups.

  • Assess platelet function [ Time Frame: upto 1 day ] [ Designated as safety issue: Yes ]
    Thromboelastography-Platelet Mapping will be performed on each patient and the results will be compared between the groups. The test will be performed before induction and in the PACU. This will determine baseline platelet function, the effect of the anesthetics.

  • Assess nasal blood flow to the sinonasal mucosa [ Time Frame: upto 1 day ] [ Designated as safety issue: Yes ]
    The Rhinolux will determine differences in the nasal blood flow between groups after induction of anesthesia, in a continous fashion. The Rhinolux is designed to measure changes in the swelling of the nasal mucosa by a tissue light absorption technique similar to that used in pulse oximetry.


Secondary Outcome Measures:
  • Comparison of operative time [ Time Frame: The day of surgery ] [ Designated as safety issue: No ]
    Operative time will be measured and compared between the 2 groups.

  • Comparison of quality of recovery. [ Time Frame: The day of surgery ] [ Designated as safety issue: No ]
    Patients will be asked regarding nausea and pain in the recovery unit. One microgram of fentanyl/kg and/or 0.05 mg of morphine would be given if the patient's numeric rating scale (NRS) of pain is more than 6 before leaving the OR. In the PACU Morphine 1-2 mg IV bolus every 5-10 minutes will be provided as well as ondansetron 4 mg IV bolus. Alternative medications and or supplements will be provided and noted if necessary.


Enrollment: 23
Study Start Date: May 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total Intravenous Anesthesia
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Drug: Propofol and Remifentanyl
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.
Other Names:
  • Propofol brand name is Diprivan
  • Remifentanyl brand name is Ultiva
Active Comparator: Inhaled Anesthesia
Inhaled anesthesia with sevoflurane and remifentanyl.
Drug: Sevoflurane and Remifentanyl
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.
Other Names:
  • Remifentanyl brand name is Ultiva
  • Sevoflurane brand name is Ultane and Sojourn

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  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 ClinicalTrials.gov identifier: NCT01214057

Locations
United States, Texas
Memorial Hermann Hospital - Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Davide Cattano, MD PhD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Davide Cattano, Associate Professor - Anesthesiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01214057     History of Changes
Other Study ID Numbers: HSC-MS-10-0014
Study First Received: August 4, 2010
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
chronic rhinosinusitis
endoscopic sinus surgery
TIVA
surgical field visualization

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anesthetics
Propofol
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014