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

This study has been completed.

First Received on October 18, 2005. Last Updated on August 3, 2010 History of Changes

Sponsor:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00242671

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 III

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Sevoflurane

U.S. FDA Resources

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:

Elective gynecological procedure
ASA I-III
Age 18-80 years
Signed informed consent

Exclusion criteria:

ASA IV
Patients with contra-indications to Sevoflurane anesthesia or other anesthetics included in the protocol
Active smoking, asthma or other history of hyper-reactive airway disease
History of chronic obstructive lung disease limiting exercise
History of angina, previous myocardial infarction, valvular heart disease, or heart surgery
Presence of heart murmurs or neck bruits
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,
History of difficult airway access
Pulmonary hypertension and/or right ventricle dysfunction
History of bulous emphysema, and/or spontaneous pneumothorax
History of alcohol or drugs abuse
Known history of psychiatric illness and/or medications
Patients that required postoperative mechanical ventilation for any reason

Contacts and Locations

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 February 21, 2012