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OpenTrials
Completed

NCT Number: NCT00752492

Acceleration of Recovery From General Anesthesia - Efficacy of Isocapnic Hyperpnoea in Obese Patients Undergoing Isoflurane Anesthesia

Faster recovery from anesthesia is important for obese patients because they are at high risk of respiratory complications following tracheal extubation. Isoflurane has several properties that make it a preferable agent for anesthesia in obese patients. Its main limitation is a longer recovery time due to slower elimination in comparison to other agents. Elimination of isoflurane from the lungs can be accelerated by increasing in patient's minute ventilation, which decreases the level of CO2 in blood (hypocapnia).Isocapnic Hyperpnoea (IH) is a method allowing increased ventilation and therefore enhancement of the elimination of inhalation agents while maintaining a normal blood CO2 level. The investigators will compare recovery time from isoflurane anesthesia in obese patients during standard anesthesia management protocol (control) to a group treated with IH.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

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 or urological procedure,

  • BMI > 35 kg/m²,
  • ASA I-III,
  • Signed informed consent.

Exclusion criteria

  • Lack of informed consent,
  • ASA IV-V,
  • Contra-indications to isoflurane anesthesia or other anesthetics included in the protocol,
  • History of cardiac or respiratory disease,
  • Alcohol or drug abuse,
  • Psychiatric illness and/or medications.

Treatment and study plan

Isocapnic Hyperpnoea

Other

IH is a method of increasing alveolar ventilation (Va) while preventing the unwanted hypocapnia by addition of CO2 to the inhaled mixture.

Primary outcomes

  1. Time from the end of anesthesia (turning isoflurane vaporizer off) to the readiness for Post Anesthesia Care Unit (PACU) discharge.

    Time frame: Intraoperatively and Post Anesthetic Care Unit

Secondary outcomes

  1. Times from end of anesthesia to BIS exceeds 75, b) eye-opening to verbal command, c) extubation, d) readiness for leaving

    Time frame: Intraoperatively and Post Anesthetic Care Unit

  2. Sedation/Pain scores in the PACU.

    Time frame: Intraoperatively and Post Anesthetic Care Unit

  3. Change in exhaled isoflurane concentrations in the 1st hour postoperatively.

    Time frame: Intraoperatively and Post Anesthetic Care Unit

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Sep 15, 2008
Registry last updated
Apr 20, 2011

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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