The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

Study Overview
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Brief Summary
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In this randomized-controlled trial the investigators will examine the effect of oxygen supplementation on the recovery of breathing for 90 minutes in the immediate post-anesthesia period starting from extubation of the trachea.

Detailed Description
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In a pilot randomized-controlled trial (NCT04723433) the investigators found that hyperoxia, compared with standard O2 supplementation, enhanced ventilation, as estimated by the fraction of time at a transcutaneous PCO2 (TcPCO2) > 45 mmHg. More specifically, patients treated with hyperoxia (O2 titrated to: SpO2 > 96%, N=10; Liberal O2) for 90 minutes post-anesthesia, spent 61.2% of the time at TcPCO2 > 45 mmHg, compared with 80.6% of the time in those receiving standard O2 supplementation (O2 titrated to: SpO2 between 90-94%, N=9; Conservative O2 - between-group difference of 19.4% (95% CI: -18.7% to 57.6%), ANCOVA adjusted P = 0.140]. Results were consistent across the 90-min monitoring period. With an observed effect size of 0.73, it was estimated that 30 participants per group are required, to demonstrate this difference with a power of 80% at a two-sided alpha of 5%. In the present confirmative 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 more hypoventilation (i.e., more time spent with an TcPCO2 > 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 > 96%).

Official Title
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Recovery of Ventilation After General Anesthesia for Robotic-Assisted Laparoscopic Nephrectomy: The Effect of Oxygen Supplementation

Conditions
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Ventilatory Depression, Postoperative Respiratory Failure

Intervention / Treatment
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* Other: Oxygen Gas for Inhalation


Participation Criteria
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Eligibility Criteria
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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 surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative O2 Supplementation<br>Oxygen administration will be titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%. | Other: Oxygen Gas for Inhalation<br>* Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.<br>|
| Experimental: Liberal O2 Supplementation<br>Oxygen administration will be titrated to an SpO2 > 96%. | Other: Oxygen Gas for Inhalation<br>* Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Ninety -minute period beginning immediately post-anesthesia. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea / hypopnea index (AHI) | The number of apnea /hypopnea episodes detected using respiratory inductance plethysmography and nasal pressure. | Ninety -minute period beginning immediately post-anesthesia. |