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NCT Number: NCT05379673

The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Anthony Doufas, MD, PhD

CONTACT

[email protected]

(650) 498-7699

Anthony Doufas, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or prostatectomy.

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.

Treatment and study plan

Oxygen Gas for Inhalation

Other

Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.

Primary outcomes

  1. Transcutaneous partial pressure of carbon dioxide (TcPCO2)

    Time frame: Ninety -minute period beginning 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)

Secondary outcomes

  1. Apnea / hypopnea index (AHI)

    Time frame: Ninety -minute period beginning immediately post-anesthesia.

    The number of apnea /hypopnea episodes detected using respiratory inductance plethysmography and nasal pressure.

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Doufas, MD, PhD

CONTACT

[email protected]

650-498-7699

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 18, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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