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OpenTrials
Completed

NCT Number: NCT01151267

Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

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.

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Key information

Conditions

Anesthesia Surgery

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Anesthesia management for post surgical patients

Other

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.

Hypercarbic Spontaneous Hyperpnoea

Device

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 outcomes

  1. 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 outcomes

  1. Comparison of pain and sedation scores

    Time frame: End of anesthesia (turning off the vaporizer) to PACU discharge, approximately 30 minutes to 2 hours

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2010
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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