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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Isocapnic Hyperponea

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital, University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 18, 2005
• First Submitted That Met QC Criteria: October 18, 2005
• First Posted (Estimate): October 20, 2005

Study Record Updates

• Last Update Posted (Estimate): August 5, 2010
• Last Update Submitted That Met QC Criteria: August 3, 2010
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: general anesthesia, hyperventilation, carbon dioxide, isocapnic hyperponea
• Other Study ID Numbers: UHN REB 05-0299-AE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No