Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy

NCT04723433 | Completed

• 1 other identifier: IRB-59593
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, controlled feasibility investigation is to characterize pharmacologically induced ventilatory depression after anesthesia and examine how is affected by the amount of supplemental oxygen patients are receiving in the immediate postoperative period.

Conditions

Ventilatory Depression; Postoperative Respiratory Complication

Outcome Measures

Primary Outcomes (1)

• 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 immediately post-anesthesia.

Study Arms (2)

"Conservative O2 Supplementation"

EXPERIMENTAL

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

Other: Oxygen gas -Conservative

"Liberal O2 Supplementation"

ACTIVE COMPARATOR

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

Other: Oxygen gas -Liberal

Interventions

Oxygen gas -Conservative OTHER

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

"Conservative O2 Supplementation"

Oxygen gas -Liberal OTHER

Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) higher than 96%.

"Liberal O2 Supplementation"

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 their surgery, will be also excluded from the study.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Doufas AG, Tian L, Kutscher S, Finnsson E, Agustsson JS, Chung BI, Panousis P. The effect of hyperoxia on ventilation during recovery from general anesthesia: A randomized pilot study for a parallel randomized controlled trial. J Clin Anesth. 2022 Dec;83:110982. doi: 10.1016/j.jclinane.2022.110982. Epub 2022 Oct 17.

  PMID: 36265267 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology, Perioperative and Pain Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: February 15, 2021
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)