Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

February 21, 2013 updated by: University Health Network, Toronto
The rate of elimination of inhalation agent is directly proportional to the degree of alveolar ventilation. Using Isocapnic Hyperpnoea (IH) device, it is possible to maintain constant end-tidal CO2 with increased minute ventilation. This is achieved by passively adding a flow of CO2 to the inspirate in proportion to increases in ventilation above the baseline. In animal and human studies IH shortens the time of awakening from isoflurane and sevoflurane anesthesia when manual positive pressure ventilation is applied. IH device could be used for spontaneous hyperpnoea as well. The investigators want to compare recovery times from sevoflurane anesthesia in patients with application of hypercapnic spontaneous hyperpnoea (HSH) versus the standard anesthesia protocol (controls). 44 patients ill be randomized to either HSH facilitated recovery, or conventional recovery (controls).The time intervals from the end of anesthesia (turning off the vaporizer) until recovery milestones will be recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • elective gynecological surgery
  • age 18-80
  • ASA I-III
  • informed consent

Exclusion Criteria:

  • ASA IV-V,
  • contra-indications to sevoflurane anesthesia or other anesthetics included in the protocol
  • history of cardiac or respiratory disease
  • intracranial pathology
  • alcohol or drug abuse
  • psychiatric illness and/or medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control Arm
The O2 flow on the anesthetic machine will be set at 15 L/min. Ventilatory assistance will be performed to maintain O2 saturation >97% and end tidal CO2 at 35-45mmHg.
Other: Standard Anesthesia management for post surgical patients
The O2 flow on the anesthetic machine will be set at 15 L/min. Ventilatory assistance will be performed to maintain O2 saturation >97% and end tidal CO2 at 35-45mmHg.
ACTIVE_COMPARATOR: HSH Group
Patient will be disconnected from the anesthetic circuit and connected to the resuscitation bag attached to the IH system. With O2 flow of 2 L/min patient will be gently ventilated until recovery of the spontaneous ventilation. After starting spontaneous ventilation basal O2 flow will be adjusted to keep ETCO2 in range of 50-60 mm Hg or minute ventilation of 15-17 L/min, whichever occurs first.
Device: Hypercarbic Spontaneous Hyperpnoea
Patient will be disconnected from the anesthetic circuit and connected to the resuscitation bag attached to the IH system. With O2 flow of 2 L/min patient will be gently ventilated until recovery of the spontaneous ventilation. After starting spontaneous ventilation basal O2 flow will be adjusted to keep ETCO2 in range of 50-60 mm Hg or minute ventilation of 15-17 L/min, whichever occurs first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from the end of anesthesia to the readiness for post-anesthesia care unit (PACU) discharge.
Time Frame: End of anesthesia (turning off the vaporizer) until readiness for PACU discharge, approximately 30 minutes to 2 hours
End of anesthesia (turning off the vaporizer) until readiness for PACU discharge, approximately 30 minutes to 2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of pain and sedation scores
Time Frame: End of anesthesia (turning off the vaporizer) to PACU discharge, approximately 30 minutes to 2 hours
End of anesthesia (turning off the vaporizer) to PACU discharge, approximately 30 minutes to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Rita Katznelson, MD, Toronto General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (ESTIMATE)

June 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 08-0017-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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