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

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT00242671
• Collaborator: (none)
• Location: 1
• Duration (Months): 38

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Procedure: Isocapnic Hyperponea	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane.
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score []

Secondary Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00242671
• Other Study ID Numbers: UHN REB 05-0299-AE
• First Posted: Oct 20, 2005
• Last Update Posted: Aug 5, 2010
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: general anesthesia, hyperventilation, carbon dioxide, isocapnic hyperponea

Study Results

No Results Posted as of Aug 5, 2010