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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242671
• Other study ID #: UHN REB 05-0299-AE
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2005
• Last updated: August 3, 2010
• Start date: October 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2006
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Isocapnic Hyperponea

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score
Secondary	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