Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Study Overview
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Brief Summary
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The investigators will conduct a 12,500-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries

Official Title
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Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Conditions
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Surgery-Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia, Surgery, Quality of Life, Pain, Postoperative, Anesthesia Morbidity, Depression, Sleep Disorders, Circadian Rhythm

Intervention / Treatment
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* Other: Anesthetic technique Propofol TIVA
* Other: Anesthetic technique inhaled agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Each patient must meet all of the following criteria: Aged 18 years or older Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device) Exclusion Criteria Patients will not be enrolled if any of the following criteria are met: Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option) 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 INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring). Locally approved, written protocol mandating a particular anesthetic technique History of intraoperative awareness during general anesthesia based on patient self-report Planned postoperative intubation Current incarceration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol total intravenous anesthesia (TIVA)<br>No administration of inhaled agent. | Other: Anesthetic technique Propofol TIVA<br>* Propofol TIVA no inhaled agent<br>* Other names: Propofol TIVA;|
| Active Comparator: inhaled volatile general anesthesia (INVA)<br>Must administer inhaled agent. | Other: Anesthetic technique inhaled agent<br>* Must administer inhaled agent.<br>* Other names: Inhaled agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery-15 (QOR 15) score on POD1 after Major inpatient surgery | We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | baseline to day 1 | 
| Quality of Recovery-15 score on POD1 after minor inpatient surgery | We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | baseline to day 1 | 
| Quality of Recovery-15 score on POD1 after Outpatient surgery | We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | baseline to day 1 | 
| Incidence of unintended intraoperative awareness with recall on POD1 or POD30 | Determine whether the incidence of intraoperative awareness with TIVA is non-inferior to that with INVA. Otherwise stated, to determine whether TIVA confers no more than a small (0.2%) increased risk of intraoperative awareness than INVA. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery-15 score on POD0 after major inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Quality of Recovery-15 score on POD0 minor inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Quality of Recovery-15 score on POD0 outpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[atient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Difference in baseline versus POD# (POD0, POD1, POD7) will be compared and assessed over the participants time in the study to measure the rate the participant returns to baseline QOR score. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Quality of Recovery-15 score on POD2 after major inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Quality of Recovery-15 score on POD2 after minor inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a)minor inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Quality of Recovery-15 score on POD2 after outpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Quality of Recovery-15 score on POD7 after major inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Quality of Recovery-15 score on POD7 after minor inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Quality of Recovery-15 score on POD7 after outpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[aitnet surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. | 7 days | 
| Incidence of delirium on POD0 after major inpatient surgery | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery. | 1 day | 
| Incidence of delirium on POD0 after minor surgery | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing minor inpatient surgery. | 1 day | 
| Incidence of delirium on POD1 after major inpatient | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery. | 1 day | 
| Incidence of delirium on POD1 after minor inpatient surgery | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery. | 1 day | 
| Incidence of delirium on POD1 after outpatient surgery | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery. | 1 day | 
| Days alive and at-home at POD30 after major inpatient surgery | The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded. | 30 days | 
| Days alive and at-home at POD30 after minor inpatient surgery | The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded. | 30 days | 
| EQ-5D-5L Quality of life on POD30 after major inpatient surgery | EQ-5D-5L Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 30 days | 
| EQ-5D-5L Quality of life on POD30 after minor inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 30 days | 
| EQ-5D-5L Quality of life on POD30 after outpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 30 days | 
| EQ-5D-5L Quality of life on POD90 after major inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 90 days | 
| EQ-5D-5L Quality of life on POD90 after minor inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 90 days | 
| EQ-5D-5L Quality of life on POD90 after outpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 90 days | 
| EQ-5D-5L Quality of life on POD180 after major inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 180 days | 
| EQ-5D-5L Quality of life on POD180 after minor inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 180 days | 
| EQ-5D-5L Quality of life on POD180 after outpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 180 days | 
| EQ-5D-5L Quality of life on POD365 after major inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 365 days | 
| EQ - 5D-5L Quality of life on POD365 after minor inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 365 days | 
| EQ-5D-5L Quality of life on POD365 after out patient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf | 365 days | 
| Bauer Questionnaire - Patient satisfaction with anesthesia at POD2 | Bauer questionnaire - Self-report satisfaction survey focused on satisfaction with anesthesia. Satisfaction is measured by reporting an experience as happening and if it did was it moderate or severe. As well as satisfaction for each aspect of anesthesia care: very satisfied, satisfied, dissatisfied, or very dissatisfied | 2 days | 
| Respiratory failure on POD0 | Respiratory failure on POD0 | 1 day | 
| kidney injury on POD7 | kidney injury on POD7 | 7 days | 
| all-cause mortality at POD30 | all-cause mortality at POD30 | 30 days | 
| all-cause mortality at POD90 | all-cause mortality at POD90 | 90 days | 
| intraoperative hypotension | intraoperative hypotension | 90 days | 
| moderate to severe intraoperative patient movement | moderate to severe intraoperative patient movement | 90 days | 
| unplanned admission after outpatient surgery in an ambulatory setting | unplanned admission after outpatient surgery in an ambulatory setting | 90 days | 
| Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR | Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR | 90 days | 
| Incidence of malignant hyperthermia as reported in the EHR | Incidence of malignant hyperthermia as reported in the EHR | 90 days | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have major inpatient surgery. | functional status | Baseline | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have minor inpatient surgery. | functional status | Baseline | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have outpatient surgery. | functional status | Baseline | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after outpatient surgery. | functional status | 30 days | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after major inpatient surgery. | functional status | 30 days | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after minor inpatient surgery. | functional status | 30 days | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after minor inpatient surgery. | functional status | 90 days | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after major inpatient surgery. | functional status | 90 days | 
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after outpatient surgery. | functional status | 90 days |