THRIVE Feasibility Trial

NCT05346588 | Completed Phase 3 DMC

• 1 other identifier: 202205053
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.

Conditions

Surgery--Complications; Anesthesia Complication; Anesthesia Awareness; Anesthesia Emergence Delirium; Anesthesia; Surgery; Quality of Life; Pain, Postoperative; Nausea, Postoperative; Anesthesia Morbidity; Depression; Sleep Disorders, Circadian Rhythm

Keywords

Quality of recovery; Intraoperative awareness

Outcome Measures

Primary Outcomes (3)

• Proportion participating

  Proportion of patients who are approached to participate by the study team and who consent to participate in the study.

  8 months

• Proportion receiving TIVA

  Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).

  8 months

• Proportion receiving inhaled anesthesia

  Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).

  8 months

Secondary Outcomes (1)

• Completeness of data collection

  11 months

Study Arms (2)

Propofol total intravenous anesthesia (TIVA)

ACTIVE COMPARATOR

No administration of inhaled agent.

Other: Anesthetic technique Propofol TIVA

Inhaled volatile general anesthesia

ACTIVE COMPARATOR

Must administer inhaled agent.

Other: Anesthetic technique inhaled agent

Interventions

Anesthetic technique Propofol TIVA OTHER

Propofol TIVA no inhaled agent

Also known as: Propofol TIVA

Propofol total intravenous anesthesia (TIVA)

Anesthetic technique inhaled agent OTHER

must administer inhaled agent.

Also known as: Inhaled agent

Inhaled volatile general anesthesia

Eligibility Criteria

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

You may qualify if:

• years or older
• Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

You may not qualify if:

• Inability to provide informed consent in English
• Pregnancy (based on patient report or positive test on the day of surgery)
• Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
• Contraindication to propofol TIVA or inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)
• Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring).
• Hospital approved, written protocol mandating a particular technique
• History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent
• Planned postoperative intubation

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Michigan: collaborator
• University of Pennsylvania: collaborator
• Stanford University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hosptial of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Tellor Pennington BR, Colquhoun DA, Neuman MD, Politi MC, Janda AM, Spino C, Thelen-Perry S, Wu Z, Kumar SS, Gregory SH, Avidan MS, Kheterpal S; THRIVE research group. Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial. BMJ Open. 2023 Apr 17;13(4):e070096. doi: 10.1136/bmjopen-2022-070096.

  PMID: 37068889 DERIVED

MeSH Terms

Conditions

Intraoperative Awareness; Emergence Delirium; Pain, Postoperative; Postoperative Nausea and Vomiting; Depression; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain; Nausea; Signs and Symptoms, Digestive; Vomiting; Behavioral Symptoms; Behavior; Chronobiology Disorders; Dyssomnias; Sleep Wake Disorders; Occupational Diseases

Study Officials

• Sachin Kheterpal, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Michael S Avidan, MBBcH

  Washington Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Anesthesiology

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 26, 2022
• Study Start: September 29, 2022
• Primary Completion: April 16, 2023
• Study Completion: June 28, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)