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

Sponsor:	University Health Network, Toronto
Collaborator:	The Physicians' Services Incorporated Foundation
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00752492

Purpose

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	Intervention
Recovery Time From Isoflurane Anesthesia in Obese Patients	Other: Isocapnic Hyperpnoea

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Acceleration of Recovery From General Anesthesia - Efficacy of Isocapnic Hyperpnoea in Obese Patients Undergoing Isoflurane Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Isoflurane

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Sedation/Pain scores in the PACU. [ Time Frame: Intraoperatively and Post Anesthetic Care Unit ] [ Designated as safety issue: No ]
Change in exhaled isoflurane concentrations in the 1st hour postoperatively. [ Time Frame: Intraoperatively and Post Anesthetic Care Unit ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	September 2008
Study Completion Date:	April 2011
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752492

Locations

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

The Physicians' Services Incorporated Foundation

Investigators

Principal Investigator:

Rita Katznelson, MD

Toronto General Hospital, University Health Network

More Information

No publications provided

Responsible Party:	Rita Katznelson, Toronto General Hospital, University Health Network
ClinicalTrials.gov Identifier:	NCT00752492 History of Changes
Other Study ID Numbers:	UHNREB08-0019B
Study First Received:	July 22, 2008
Last Updated:	April 19, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Isocapnic hyperpnoea
obesity
isoflurane
Recovery of obese patient from isoflurane anesthesia

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anesthetics
Isoflurane

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on February 09, 2012