The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

Ventilatory Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379673
• Other study ID #: IRB-63878
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Anthony Doufas, MD, PhD
• Phone: 650-498-7699
• Email: agdoufas[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Respiratory Failure
• Respiratory Insufficiency
• Ventilatory Depression

Intervention

Other:
• Oxygen Gas for Inhalation
Oxyhemoglobin saturation (SpO2) higher than 96% vs SpO2 between 90% and 94%.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.