Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

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.

Study Overview

• Status: Completed
• Conditions: Hypercapnia
• Intervention / Treatment: Device: Quick Emergence Device; Other: standard of care for phase one anesthesia care

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: QED-100 from Anecare Inc
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery From Anesthesia	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).	up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of Cognitive Function	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	up to 30 minutes

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Anecare
• Investigators: Principal Investigator: Dwayne Westenskow, University of Utah

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: June 30, 2008
• First Posted (Estimate): July 2, 2008

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: hypercapnia; hyperpnoea; accelerated recovery
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 26111