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Completed

NCT Number: NCT01477398

Improved Patient Recovery After Anesthesia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QED-100

Device

Use of the QED-100 results in mild hypercapnia during emergence

Other names: Quick Recovery Device, AneClear

Primary outcomes

  1. treatment (inspired CO2) caused patients to breath more vigorously

    Time frame: 30 min

    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 outcomes

  1. treatment caused the anesthetic vapors to be cleared more rapidly

    Time frame: 30 min

    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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Improved Patient Recovery of Spontaneous Respiration After Anesthesia With Hypercapnic Hyperpnoea

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2011
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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