Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

NCT00708526 | Completed Results DMC

• 1 other identifier: 26111
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercapnia

Keywords

hypercapnia; hyperpnoea; accelerated recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Return of Cognitive Function

  up to 30 minutes

Study Arms (2)

Phase 1 Recovery

EXPERIMENTAL

Quick Emergence Device is in place for phase 1 anesthesia recovery

Device: Quick Emergence Device

Standard of care

OTHER

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

Other: standard of care for phase one anesthesia care

Interventions

standard of care for phase one anesthesia care OTHER

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.

Standard of care

Quick Emergence Device 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.

Also known as: QED-100 from Anecare Inc

Phase 1 Recovery

Eligibility Criteria

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

You may qualify if:

• adults
• ASA class I-III
• 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
• 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.

Sponsors & Collaborators

• University of Utah: lead
• Anecare: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Hypercapnia; Hyperventilation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dwayne Westenskow, PhD
• Organization: University of Utah

Dwayne.Westenskow@hsc.utah.edu

801-581-2478

Study Officials

• Dwayne Westenskow

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 2, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 29, 2022
• Results First Posted: October 19, 2011

Record last verified: 2022-11

Locations

US (1)