The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia
Intervention: Isocapnic Hyperponea (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s): Rita Katznelson, MD, Principal Investigator, Affiliation: Toronto General Hospital, University Health Network
Summary
The twilight phase between being asleep and awake during recovery from anesthesia is a
precarious time fraught with risks to the post-operative patient. Hyperventilation
accelerates the elimination of inhaled anesthetics but reduces their CO2 blood
concentrations which delays their resumption of spontaneous breathing. We previously showed
that our method of hyperventilation without affecting the CO2 concentration--which we call
IH--accelerates the rate of emergence from anesthesia with isoflurane. In this study we
will study the effect of IH on the rate of emergence from Sevoflurane anesthesia.
Clinical Details
Official title: The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score
Secondary outcome: Quality of recovery in the recovery room as indicated by the level of consciousness, incidence of nausea, vomiting, shivering and other phenomena occuring during recovery
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
Inclusion criteria:
1. Elective gynecological procedure
2. ASA I-III
3. Age 18-80 years
4. Signed informed consent
Exclusion criteria:
1. ASA IV
2. Patients with contra-indications to Sevoflurane anesthesia or other anesthetics
included in the protocol
3. Active smoking, asthma or other history of hyper-reactive airway disease
4. History of chronic obstructive lung disease limiting exercise
5. History of angina, previous myocardial infarction, valvular heart disease, or heart
surgery
6. Presence of heart murmurs or neck bruits
7. ECT abnormalities including atrial fibrillation, prolonged P-R interval, prolonged
Q-T interval, presence of Q waves in inferior, anterior or lateral leads, criteria
for left ventricular hypertrophy, T-wave abnormalities,
8. History of difficult airway access
9. Pulmonary hypertension and/or right ventricle dysfunction
10. History of bulous emphysema, and/or spontaneous pneumothorax
11. History of alcohol or drugs abuse
12. Known history of psychiatric illness and/or medications
13. Patients that required postoperative mechanical ventilation for any reason
Locations and Contacts
Toronto General Hospital, University Health Network, Toronto, Ontario M5G 2C4, Canada
Additional Information
Starting date: October 2005
Last updated: August 3, 2010
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