Back to resultsImproved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea
Primary Purpose
Hypercapnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard of care for phase one anesthesia care
Quick Emergence Device
Sponsored by
About this trial
This is an interventional health services research trial for Hypercapnia focused on measuring hypercapnia, hyperpnoea, accelerated recovery
Eligibility 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.
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Phase 1 Recovery
Standard of care
Arm Description
Quick Emergence Device is in place for phase 1 anesthesia recovery
Tidal volume and respiratory rate are not changed during phase 1 recovery from anesthesia
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00708526
First Posted
June 30, 2008
Last Updated
November 2, 2022
Sponsor
University of Utah
Collaborators
Anecare
1. Study Identification
Unique Protocol Identification Number
NCT00708526
Brief Title
Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea
Official Title
Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
Anecare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia
Keywords
hypercapnia, hyperpnoea, accelerated recovery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1 Recovery
Arm Type
Experimental
Arm Description
Quick Emergence Device is in place for phase 1 anesthesia recovery
Arm Title
Standard of care
Arm Type
Other
Arm Description
Tidal volume and respiratory rate are not changed during phase 1 recovery from anesthesia
Intervention Type
Other
Intervention Name(s)
standard of care for phase one anesthesia care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Quick Emergence Device
Other Intervention Name(s)
QED-100 from Anecare Inc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recovery From Anesthesia
Description
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).
Time Frame
up to 2 hours
Secondary Outcome Measure Information:
Title
Return of Cognitive Function
Description
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
Time Frame
up to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwayne Westenskow
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea
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