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Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy

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Stanford University

Status

Completed

Conditions

Postoperative Respiratory Complication
Ventilatory Depression

Treatments

Other: Oxygen gas -Liberal
Other: Oxygen gas -Conservative

Study type

Interventional

Funder types

Other

Identifiers

NCT04723433
IRB-59593

Details and patient eligibility

About

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.

Full 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%).

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

"Conservative O2 Supplementation"
Experimental group
Description:
Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.
Treatment:
Other: Oxygen gas -Conservative
"Liberal O2 Supplementation"
Active Comparator group
Description:
Oxygen administration will titrated to an SpO2 \> 96%.
Treatment:
Other: Oxygen gas -Liberal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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