Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01151267
Collaborator
(none)
44
1
2
39
1.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard Anesthesia management for post surgical patients
  • Device: Hypercarbic Spontaneous Hyperpnoea
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Comparison of pain and sedation scores [End of anesthesia (turning off the vaporizer) to PACU discharge, approximately 30 minutes to 2 hours]

Eligibility Criteria

Criteria

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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01151267
Other Study ID Numbers:
  • UHN REB 08-0017-B
First Posted:
Jun 28, 2010
Last Update Posted:
Feb 22, 2013
Last Verified:
Feb 1, 2013
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2013