Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

Surgery Clinical Trial

Official title:

Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151267
• Other study ID #: UHN REB 08-0017-B
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: February 21, 2013
• Start date: July 2009
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

Other:
• Standard Anesthesia management for post surgical patients
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.

Device:
• Hypercarbic Spontaneous Hyperpnoea
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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from the end of anesthesia to the readiness for post-anesthesia care unit (PACU) discharge.		End of anesthesia (turning off the vaporizer) until readiness for PACU discharge, approximately 30 minutes to 2 hours	No
Secondary	Comparison of pain and sedation scores		End of anesthesia (turning off the vaporizer) to PACU discharge, approximately 30 minutes to 2 hours	No