Improved Patient Recovery After Anesthesia

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT01477398

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Recovery From Anesthesia	Device: QED-100	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Improved Patient Recovery of Spontaneous Respiration After Anesthesia With Hypercapnic Hyperpnoea

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

treatment (inspired CO2) caused patients to breath more vigorously [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 Outcome Measures

treatment caused the anesthetic vapors to be cleared more rapidly [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Utah

ClinicalTrials.gov Identifier:

NCT01477398

Other Study ID Numbers:

36354

First Posted:

Nov 22, 2011

Last Update Posted:

Aug 22, 2016

Last Verified:

Aug 1, 2016

Study Results

No Results Posted as of Aug 22, 2016