Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

NCT01151267 | Completed

• 1 other identifier: UHN REB 08-0017-B
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Surgery

Keywords

Isocapnic hyperpnoea (IH); Anesthesia; Accelerate elimination of inhalation agents; Recovery from anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Comparison of pain and sedation scores

  End of anesthesia (turning off the vaporizer) to PACU discharge, approximately 30 minutes to 2 hours

Study Arms (2)

Control Arm

OTHER

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.

Other: Standard Anesthesia management for post surgical patients

HSH Group

ACTIVE COMPARATOR

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.

Device: Hypercarbic Spontaneous Hyperpnoea

Interventions

Standard Anesthesia management for post surgical patients OTHER

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.

Control Arm

Hypercarbic Spontaneous Hyperpnoea DEVICE

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.

HSH Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective gynecological surgery
• age 18-80
• ASA I-III
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

• Rita Katznelson, MD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: June 28, 2010
• Study Start: July 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

CA (1)