Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

NCT ID: NCT01151267

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Arm

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.

Group Type: OTHER

Standard Anesthesia management for post surgical patients

Intervention Type: 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.

HSH Group

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.

Group Type: ACTIVE_COMPARATOR

Hypercarbic Spontaneous Hyperpnoea

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita Katznelson, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital

Locations

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 08-0017-B

Identifier Type: -

Identifier Source: org_study_id