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Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

Primary Purpose

Anesthesia, Surgery

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard Anesthesia management for post surgical patients
Hypercarbic Spontaneous Hyperpnoea
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Isocapnic hyperpnoea (IH), Anesthesia, Accelerate elimination of inhalation agents, Recovery from anesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto General Hospital, University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control Arm

HSH Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time from the end of anesthesia to the readiness for post-anesthesia care unit (PACU) discharge.

Secondary Outcome Measures

Comparison of pain and sedation scores

Full Information

First Posted
May 17, 2010
Last Updated
February 21, 2013
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01151267
Brief Title
Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia
Official Title
Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Surgery
Keywords
Isocapnic hyperpnoea (IH), Anesthesia, Accelerate elimination of inhalation agents, Recovery from anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Other
Arm Description
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.
Arm Title
HSH Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Anesthesia management for post surgical patients
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hypercarbic Spontaneous Hyperpnoea
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Comparison of pain and sedation scores
Time Frame
End of anesthesia (turning off the vaporizer) to PACU discharge, approximately 30 minutes to 2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Katznelson, MD
Organizational Affiliation
Toronto General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

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Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

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