The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00242671
First received: October 18, 2005
Last updated: August 3, 2010
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Anesthesia
Procedure: Isocapnic Hyperponea
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane.

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score

Secondary Outcome Measures:
  • 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

Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00242671

Locations
Canada, Ontario
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Rita Katznelson, MD Toronto General Hospital, University Health Network
  More Information

No publications provided

Responsible Party: Rita Katznelson, Toronto General Hospital, University Health Network
ClinicalTrials.gov Identifier: NCT00242671     History of Changes
Other Study ID Numbers: UHN REB 05-0299-AE
Study First Received: October 18, 2005
Last Updated: August 3, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
general anesthesia, hyperventilation, carbon dioxide, isocapnic hyperponea

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on July 22, 2014