Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

This study has been completed.
Sponsor:
Collaborator:
Anecare
Information provided by (Responsible Party):
Dwayne Westenskow, University of Utah
ClinicalTrials.gov Identifier:
NCT00708526
First received: June 30, 2008
Last updated: October 18, 2011
Last verified: October 2011
  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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Respiratory
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014