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Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723433
Recruitment Status : Completed
First Posted : January 25, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Anthony Doufas, Stanford University

Study Description
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Brief Summary:
The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.

Condition or disease Intervention/treatment Phase
Ventilatory Depression Postoperative Respiratory Complication Other: Oxygen gas -Conservative Other: Oxygen gas -Liberal Not Applicable

Detailed Description:

The purpose of this study is characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period, since hyperoxemia (ie., higher than necessary partial pressure of oxygen in the arterial blood) has been associated with ventilatory depression via suppression of the hypoxic ventilatory drive.

In this feasibility randomized controlled trial, the investigators plan to estimate and compare the cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide will exceed an upper limit of 45 mmHg (i.e., TcPCO2 > 45 mmHg) for the 90-min-long post-anesthesia period, between the conventional (titrated to an oxygen saturation > 96%) and the conservative (titrated to O2 saturation 90 -94%) O2 supplementation interventions.

Hypothesis: Conservative use of O2 (titrated to an SpO2: 90 - 94%), will be associated with less hypoventilation (i.e., less time spent with an TcPCO2 > 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 > 96%).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the post-anesthesia care unit (PACU), participants will be randomized to receive conservative (titrated to an SpO2 between 90 and 94%) versus liberal (titrated to SpO2 > 96%) oxygen supplementation, via a non-rebreather mask.
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Recovery of Ventilation After General Anesthesia for Robotic-assisted Laparoscopic Nephrectomy: The Effect of Conservative Versus Liberal Oxygen Supplementation - A Feasibility Study
Actual Study Start Date : February 15, 2021
Actual Primary Completion Date : June 15, 2021
Actual Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: "Conservative O2 Supplementation"
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.
 Other: Oxygen gas -Conservative
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90% and 94%.
Active Comparator: "Liberal O2 Supplementation"
Oxygen administration will titrated to an SpO2 > 96%.
 Other: Oxygen gas -Liberal
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) higher than 96%.


Outcome Measures
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Primary Outcome Measures :
  1. Transcutaneous partial pressure of carbon dioxide (TcPCO2) [ Time Frame: Ninety -minute period immediately post-anesthesia. ]
    The cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide (TcPCO2: primary outcome) will exceed an upper limit of 45 mmHg (i.e., TcPCO2 > 45 mmHg)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body mass index (BMI) less than 40 kg/m2
  • Scheduled to undergo robotic-assisted radical laparoscopic nephrectomy.

Exclusion Criteria:

  • Patients with a diagnosis of chronic obstructive pulmonary disorder (COPD), severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder
  • Chronic pain condition that is being treated with opioids
  • Patients with a hematocrit lower than 30% at the end of surgery, or those with an excessive blood loss, requiring transfusion of blood products during their surgery, will be also excluded from the study.
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): NCT04723433


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
More Information
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Responsible Party: Anthony Doufas, Professor, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04723433    
Other Study ID Numbers: IRB-59593
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases