The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

NCT ID: NCT05379673

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

"Conservative O2 Supplementation"

Oxygen administration will be titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.

Group Type: ACTIVE_COMPARATOR

Oxygen Gas for Inhalation

Intervention Type: OTHER

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

"Liberal O2 Supplementation"

Oxygen administration will be titrated to an SpO2 \> 96%.

Group Type: EXPERIMENTAL

Oxygen Gas for Inhalation

Intervention Type: OTHER

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

Interventions

Oxygen Gas for Inhalation

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Anthony Doufas

Professor, Department of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Doufas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Department of Anesthesiology, Stanford University Medical School

Locations

Stanford University School of Medicine

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anthony Doufas, MD, PhD

Role: CONTACT

agdoufas@stanford.edu

650-498-7699

Facility Contacts

Anthony Doufas, MD, PhD

Role: primary

agdoufas@stanford.edu

(650) 498-7699

Other Identifiers

IRB-63878

Identifier Type: -

Identifier Source: org_study_id