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Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia

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ClinicalTrials.gov Identifier: NCT01835600
Recruitment Status : Unknown
Verified April 2013 by Yi Zhou, Chinese Medical Association.
Recruitment status was:  Not yet recruiting
First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Yi Zhou, Chinese Medical Association

Study Description
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Brief Summary:
For some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed under general anesthesia with interrupted suspension of mechanical ventilation, which could result in hypercapnia and hypoxia. In this study, the investigators hypothesize that 10 cmH2O PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.

Condition or disease Intervention/treatment Phase
Hypercapnia Hypoxia Other: PEEP Not Applicable

Detailed Description:
For some upper ureteral and renal stones,ureteroscopic lithotripsy is often perdurbed by the patient's respiratory movement either under epidural anesthesia or general anesthesia with mechanical ventilation. So intermittent suspension of mechanical ventilation under general anesthesia can ensure the surgery to be performed continuously and successfully. But this could result in hypercapnia and hypoxia. So far, there have been few studies focused on the change of the internal environment in blood as result of suspending breath. In this study, the investigators hypothesize that 10 cmH2O PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Study Start Date : April 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : November 2013
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: with PEEP
10 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation
 Other: PEEP
PEEP means that when mechanical ventilation is suspended, the value of expiratory valve in the anesthesia machine is set at 10 cmH2O with 1 L/min 100% oxygen.
Other Name: positive end-expiratory pressure
Placebo Comparator: without PEEP
0 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation


Outcome Measures
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Primary Outcome Measures :
  1. change in blood gas [ Time Frame: Baseline before suspension of ventilation, 5 min after suspension, 10 min after suspension, 15 min after suspension, 5 min after re-ventilaiton, 10 min after re-ventilation ]
    we chose different time points to mesure the changes in blood gas.


Secondary Outcome Measures :
  1. Change in systolic blood pressure [ Time Frame: Baseline before suspension of ventilation, 5 min after suspension, 10 min after suspension, 15 min after suspension, 5 min after re-ventilaiton, 10 min after re-ventilation ]
    we chose different time points to mesure the changes in systolic blood pressure


Other Outcome Measures:
  1. duration of the operation [ Time Frame: from the start of the surgery to the end of the surgery ]
    We record the duration of the operation

  2. recovery time [ Time Frame: from the end of anesthesia to return of consciousness ]
    We record how long it will take for the patients to act accoreding to our order after ceasing anesthesia.

  3. intraoperative awareness [ Time Frame: from the initiation of anesthesia to the end of the surgery ]
    We will record if patinets have any memory during the operative, namely intraoperatiove awareness.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ASA I~III general anesthesia sign the informed consent

Exclusion Criteria:

ASA IV or V woman who is pregnant or plans to bear

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835600


Locations
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China, Shanghai
Yi Zhou Active, not recruiting
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Chinese Medical Association
More Information
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Responsible Party: Yi Zhou, Department of Anesthesiology , Changhai Hospital Affiliated to Second Military Medical, Chinese Medical Association
ClinicalTrials.gov Identifier: NCT01835600     History of Changes
Other Study ID Numbers: SMV-312
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Hypoxia
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms