NCT05379673

The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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%).

Conditions

• Ventilatory Depression
• Postoperative Respiratory Failure

Interventions

Type	Name	Description
OTHER	Oxygen Gas for Inhalation	Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.

Timeline

• Start date: 2022-10-04
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2022-05-18
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States