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Completed

NCT Number: NCT00708526

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.

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Key information

Conditions

Hypercapnia Hyperventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Other names: QED-100 from Anecare Inc

Primary outcomes

  1. Recovery From Anesthesia

    Time frame: up to 2 hours

    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 outcomes

  1. Return of Cognitive Function

    Time frame: up to 30 minutes

    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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Anecare

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 2, 2008
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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