Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea - Full Text View

Sponsors and Collaborators:	University of Utah Anecare
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00708526

Purpose

The proposed study will measure the decrease in time to meet discharge criteria from the PACU and a reduction in the incidence of adverse events when hypercapnic hyperpnoea is used during emergence.

Condition	Intervention	Phase
Hypercapnia	Device: QED Other: standard of care for phase one anesthesia care	Phase II

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Safety Study
Official Title:	Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

Further study details as provided by University of Utah:

Primary Outcome Measures:

decrease in time to meet discharge criteria from the PACU [ Time Frame: Phase 1 anesthesia recovery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

a reduction in the incidence of adverse events when hypercapnic hyperpnoea is used during emergence. [ Time Frame: Phase 1 anesthesia recovery ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	March 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental QED is in place for phase 1 anesthesia recovery	Device: QED The QED is place in the anesthesia circuit prior to wake up
1: Active Comparator monitoring of subject recovering during anesthesia phase 1 and phase 2	Other: standard of care for phase one anesthesia care standard of care

Detailed Description:

Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia (1-4). In our first clinical study with isoflurane we confirmed that the time from turning off the vaporizer to opening of eyes was shortened by an average of 62% when the minute ventilation was elevated and the EtCO2 was kept at 52 mmHg rather than 28 mmHg during emergence (5). In our second study we found that hypercapnia and hyperpnoea accelerated recovery proportionately for sevoflurane and desflurane (6). The benefits of accelerating subject recovery in the operating room may extend to the entire recovery period if the subject is more alert and easier to care for when they arrive in the post anesthesia care unit (PACU).

Eligibility

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

Criteria

Inclusion Criteria:

adults
ASA class I-III
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
personal/familial history of malignant hyperthermia.
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).
intolerance to non-steroidal anti-inflammatories.
have received general anesthesia within the previous 7 days,
received any investigational drug within the previous 28 days,
participated in a previous isoflurane or desflurane study
Female subjects can be neither pregnant nor breast feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708526

Locations

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

University of Utah

Anecare

Investigators

Principal Investigator:

Dwayne Westenskow

University of Utah

More Information

Responsible Party:	Anecare ( Dwayne Westenskow )
Study ID Numbers:	26111
Study First Received:	June 30, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00708526
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

hypercapnia
hyperpnoea
accelerated recovery

Study placed in the following topic categories:

Signs and Symptoms
Hypercapnia
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on January 14, 2009