Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

Hypercapnia Clinical Trial

Official title:

Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708526
• Other study ID #: 26111
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypercapnia

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Anecare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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