Improved Patient Recovery After Anesthesia

NCT01477398 | Completed Early Phase 1 DMC

• 1 other identifier: 36354
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recovery From Anesthesia

Outcome Measures

Primary Outcomes (1)

• treatment (inspired CO2) caused patients to breath more vigorously

  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

  30 min

Secondary Outcomes (1)

• treatment caused the anesthetic vapors to be cleared more rapidly

  30 min

Study Arms (2)

inspired CO2

ACTIVE COMPARATOR

Inspired CO2

Device: QED-100

No intervention: Standard of Care

NO INTERVENTION

tidal volume and respiratory rate are not changed during recovery from anesthesia

Interventions

QED-100 DEVICE

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

Also known as: Quick Recovery Device, AneClear

inspired CO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 22, 2011
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 22, 2016

Record last verified: 2016-08