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Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy

Primary Purpose

Ventilatory Depression, Postoperative Respiratory Complication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen gas -Conservative
Oxygen gas -Liberal
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilatory Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"Conservative O2 Supplementation"

"Liberal O2 Supplementation"

Arm Description

Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.

Oxygen administration will titrated to an SpO2 > 96%.

Outcomes

Primary Outcome Measures

Transcutaneous partial pressure of carbon dioxide (TcPCO2)
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)

Secondary Outcome Measures

Full Information

First Posted
January 21, 2021
Last Updated
September 11, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04723433
Brief Title
Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy
Official Title
Recovery of Ventilation After General Anesthesia for Robotic-assisted Laparoscopic Nephrectomy: The Effect of Conservative Versus Liberal Oxygen Supplementation - A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Depression, Postoperative Respiratory Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Conservative O2 Supplementation"
Arm Type
Experimental
Arm Description
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.
Arm Title
"Liberal O2 Supplementation"
Arm Type
Active Comparator
Arm Description
Oxygen administration will titrated to an SpO2 > 96%.
Intervention Type
Other
Intervention Name(s)
Oxygen gas -Conservative
Intervention Description
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90% and 94%.
Intervention Type
Other
Intervention Name(s)
Oxygen gas -Liberal
Intervention Description
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) higher than 96%.
Primary Outcome Measure Information:
Title
Transcutaneous partial pressure of carbon dioxide (TcPCO2)
Description
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)
Time Frame
Ninety -minute period immediately post-anesthesia.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36265267
Citation
Doufas AG, Tian L, Kutscher S, Finnsson E, Agustsson JS, Chung BI, Panousis P. The effect of hyperoxia on ventilation during recovery from general anesthesia: A randomized pilot study for a parallel randomized controlled trial. J Clin Anesth. 2022 Dec;83:110982. doi: 10.1016/j.jclinane.2022.110982. Epub 2022 Oct 17.
Results Reference
derived

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Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy

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