| July 22, 2008 |
| September 12, 2008 |
| September 2008 |
| August 2010 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00752492 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Acceleration of Recovery From General Anesthesia - Efficacy of Isocapnic Hyperpnoea in Obese Patients Undergoing Isoflurane Anesthesia |
| 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. |
| |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Subject), Dose Comparison, Single Group Assignment, Efficacy Study |
| Isoflurane Anesthesia |
| Other: Isocapnic Hyperpnoea |
| Active Comparator: 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. |
| |
| |
| Recruiting |
| 44 |
| August 2010 |
| August 2010 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 80 Years |
| No |
|
|
| Canada |
| |
| NCT00752492 |
| Rita Katznelson, Toronto General Hospital, University Health Network |
| UHNREB08-0019B |
| University Health Network, Toronto |
| The Physicians' Services Incorporated Foundation |
| Principal Investigator: |
Rita Katznelson, MD |
Toronto General Hospital, University Health Network |
|
|
| University Health Network, Toronto |
| July 2008 |
