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

Purpose

The proposed study will measure the time from the end of surgery until the time patients meet the discharge criteria from the postoperative anesthesia care unit and the time from the end of surgery until the patients regained cognitive function after anesthesia.

Condition	Intervention	Phase
Hypercapnia	Other: standard of care for phase one anesthesia care Device: Quick Emergence Device	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Health Services Research
Official Title:	Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

Further study details as provided by University of Utah:

Primary Outcome Measures:

Recovery From Anesthesia [ Time Frame: up to 2 hours ] [ Designated as safety issue: Yes ]
average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).

Secondary Outcome Measures:

Return of Cognitive Function [ Time Frame: up to 30 minutes ] [ Designated as safety issue: Yes ]
average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth

Enrollment:	22
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
Experimental: Phase 1 Recovery Quick Emergence Device is in place for phase 1 anesthesia recovery	Device: Quick Emergence Device The Quick Emergence Device is placed between the endotracheal tube and the anesthesia breathing circuit to enable hypercapnia when ventilation is increased. The end-tidal gas sampling line is connected between the device and the endotracheal tube connector. Minute ventilation is doubled and the EtCO2 is elevated to approximately 48 mmHg from the previous maintenance level of 35 mmHg. Other Name: QED-100 from Anecare Inc
No Intervention: Standard of care Tidal volume and respiratory rate are not changed during phase 1 recovery from anesthesia	Other: standard of care for phase one anesthesia care Patients received intravenous fentanyl at the discretion of the attending anesthesiologist. Anesthesia was induced with a remifentanil infusion, lidocaine, propofol, and rocuronium or succinylcholine at the anesthesiologist's discretion. Maintenance anesthesia was 6% end tidal desflurane with oxygen flows of 2 L/min (though clinicians could deviate from this at their discretion). Clinicians were directed to maintain blood pressure at ±20% of baseline. A baseline remifentanil infusion was used throughout each case, and both remifentanil and fentanyl were titrated at the anesthesiologist's discretion. Ventilation was adjusted to maintain an end tidal carbon dioxide concentration (EtCO2) of 35 mmHg. Ondansetron 4 mg was given prophylactically before the end of surgery.

Arms

Assigned Interventions

Experimental: Phase 1 Recovery

Quick Emergence Device is in place for phase 1 anesthesia recovery

Device: Quick Emergence Device

The Quick Emergence Device is placed between the endotracheal tube and the anesthesia breathing circuit to enable hypercapnia when ventilation is increased. The end-tidal gas sampling line is connected between the device and the endotracheal tube connector. Minute ventilation is doubled and the EtCO2 is elevated to approximately 48 mmHg from the previous maintenance level of 35 mmHg.

Other Name: QED-100 from Anecare Inc

No Intervention: Standard of care

Tidal volume and respiratory rate are not changed during phase 1 recovery from anesthesia

Other: standard of care for phase one anesthesia care

Patients received intravenous fentanyl at the discretion of the attending anesthesiologist. Anesthesia was induced with a remifentanil infusion, lidocaine, propofol, and rocuronium or succinylcholine at the anesthesiologist's discretion. Maintenance anesthesia was 6% end tidal desflurane with oxygen flows of 2 L/min (though clinicians could deviate from this at their discretion). Clinicians were directed to maintain blood pressure at ±20% of baseline. A baseline remifentanil infusion was used throughout each case, and both remifentanil and fentanyl were titrated at the anesthesiologist's discretion. Ventilation was adjusted to maintain an end tidal carbon dioxide concentration (EtCO2) of 35 mmHg. Ondansetron 4 mg was given prophylactically before the end of surgery.

Detailed Description:

Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. 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 end tidal carbon dioxide concentration was kept at 52 mmHg rather than 28 mmHg during emergence. In our second study we found that hypercapnia and hyperpnoea accelerated recovery proportionately for sevoflurane and desflurane. 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.

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

No publications provided

Responsible Party:	Dwayne Westenskow, Professor, University of Utah
ClinicalTrials.gov Identifier:	NCT00708526 History of Changes
Other Study ID Numbers:	26111
Study First Received:	June 30, 2008
Results First Received:	January 30, 2009
Last Updated:	October 18, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

hypercapnia
hyperpnoea
accelerated recovery

Additional relevant MeSH terms:

Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013