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

NCT00242671 | Completed Phase 3

• 1 other identifier: UHN REB 05-0299-AE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

general anesthesia, hyperventilation, carbon dioxide, isocapnic hyperponea

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

Isocapnic Hyperponea PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Hyperventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rita Katznelson, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2005
• First Posted: October 20, 2005
• Study Start: October 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 5, 2010

Record last verified: 2006-09

Locations

CA (1)