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

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ClinicalTrials.gov Identifier: NCT00752492
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : April 20, 2011
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recovery Time From Isoflurane Anesthesia in Obese Patients Other: Isocapnic Hyperpnoea Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acceleration of Recovery From General Anesthesia - Efficacy of Isocapnic Hyperpnoea in Obese Patients Undergoing Isoflurane Anesthesia
Study Start Date : September 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Isoflurane

Arm Intervention/treatment
Active Comparator: Study intervention
Patient will be disconnected from the anesthetic circuit and connected to the resuscitation bag attached to the IH system. Ventilation will be assisted to maintain tidal volume of 8-10 mL/kg and respiratory rate of 20-25 breaths per minute to achieve minute ventilation of 15-20 L/min. Isocapnia manifold will maintain end-tidal PCO2 in range of 40-50 mm Hg.
Other: Isocapnic Hyperpnoea
IH is a method of increasing alveolar ventilation (Va) while preventing the unwanted hypocapnia by addition of CO2 to the inhaled mixture.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752492


Locations
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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: Rita Katznelson, MD Toronto General Hospital, University Health Network

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Responsible Party: Rita Katznelson, Toronto General Hospital, University Health Network
ClinicalTrials.gov Identifier: NCT00752492     History of Changes
Other Study ID Numbers: UHNREB08-0019B
First Posted: September 15, 2008    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: April 2011
Keywords provided by University Health Network, Toronto:
Isocapnic hyperpnoea
obesity
isoflurane
Recovery of obese patient from isoflurane anesthesia
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Inhalation
Anesthetics, General
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs