Improved Patient Recovery After Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dwayne Westenskow, University of Utah
ClinicalTrials.gov Identifier:
NCT01477398
First received: November 14, 2011
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

The proposed study will measure the incidence of adverse events and the decrease in time to meet discharge criteria from the post anesthesia care unit when hypercapnic and hyperpnoea are used during emergence.


Condition Intervention
Recovery From Anesthesia
Device: QED-100

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improved Patient Recovery of Spontaneous Respiration After Anesthesia With Hypercapnic Hyperpnoea

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • treatment (inspired CO2) caused patients to breath more vigorously [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    Chest bands measuring the patients tidal volume will show that patients who receive the treatment will have larger tidal volumes than patients in the control group during the first 10 minutes after the end of surgery


Secondary Outcome Measures:
  • treatment caused the anesthetic vapors to be cleared more rapidly [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    A anesthetic gas analyzer will measure the amount of anesthetic gas in the patient's exhaled gas and will show that patients who receive the treatment will have lower exhaled anesthetic gas concentration than patients in the control group during the first 10 minutes after the end of surgery


Enrollment: 31
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: inspired CO2
Inspired CO2
Device: QED-100
Use of the QED-100 results in mild hypercapnia during emergence
Other Names:
  • Quick Recovery Device
  • AneClear
No Intervention: No intervention: Standard of Care
tidal volume and respiratory rate are not changed during recovery from anesthesia

Detailed Description:

Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. The benefits of accelerating patient recovery in the operating room may extend to the post anesthesia care unit if the patient is more alert and easier to care for when they arrive in the unit. Respiratory patterns and gas levels - including CO2, O2, and anesthetic vapor - will be measured in order to better understand a patient's respiratory status during recovery.

In Feb 2009 we finished our first study (IRB 26111) and submitted a publication. The journal reviewers identified a serious limitation: we could not report whether the treated patients recovered from anesthesia faster because the treatment (inspired CO2) caused them to breath more vigorously or because the treatment caused the anesthetic vapors to be cleared more rapidly from the brain. Our new application uses essentially the same study protocol as the former study but adds chest bands to measure the patient's rate of breathing and expired gas monitoring to measure the rate at which the vapors are removed.

  Eligibility

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

Inclusion Criteria:

  • adult ASA class I-III subjects of both genders scheduled to undergo eye surgery at the Moran Hospital.

Exclusion Criteria:

  • a history of renal or hepatic disease, chronic alcohol or drug abuse, disabling neuropsychiatric disorder, hypersensitivity, or unusual response to other halogenated anesthetics, pulmonary hypertension, increased intracranial pressure, seizure disorder, or personal/familial history of malignant hyperthermia, and current smokers.
  • Subjects will also be excluded if they are currently being treated with known hepatic enzyme-inducing drugs (e.g., phenobarbital, dilantin, or isoniazid) or with drugs known to alter anesthetic requirements (e.g., opiates, clonidine, alpha2 agonists, alcohol, anticonvulsants, antidepressants, barbiturates, benzodiazepines or other tranquilizers).
  • Subjects will also be excluded if they have intolerance to non-steroidal anti-inflammatories.
  • In addition subjects who have received general anesthesia within the previous 7 days, received any investigational drug within the previous 28 days, or participated in a previous isoflurane or desflurane study will be excluded.
  • Female subjects can be neither pregnant nor breast feeding.
  • Subjects with significant restrictive lung disease will also be excluded.
  • Subjects passing these criteria will be further evaluated with a medical history including medications, abbreviated physical examination, clinical laboratory tests (urine drug test), and a urine or serum human chorionic gonadotropin pregnancy test for women with childbearing potential.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01477398

Locations
United States, Utah
Moran Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
  More Information

No publications provided

Responsible Party: Dwayne Westenskow, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01477398     History of Changes
Other Study ID Numbers: 36354
Study First Received: November 14, 2011
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014