Inhalational vs Intravenous Anesthesia for Surgery Patients

(TIVA GAS Trial)

Overseen By Sarah L. Feller, BS

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Disqualifiers: Dementia, Parkinson's, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Surgery duration

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of anesthesia to determine which is better for older adults undergoing non-heart-related surgeries. It compares intravenous anesthesia using propofol with inhalational anesthesia using sevoflurane. The goal is to determine if intravenous anesthesia can reduce post-surgery confusion and improve patient recovery and function. This trial may suit men and women aged 70 or older scheduled for major surgery lasting at least two hours and requiring general anesthesia. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, aiming to understand their benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that propofol, administered intravenously for anesthesia, works effectively but can cause heart and lung issues in some individuals. Studies found that 69% of patients experienced some problems with propofol. However, trained professionals, even those who aren't anesthesiologists, often administer it safely to low-risk patients.

Sevoflurane, another anesthesia option delivered through a mask, is generally safe but can occasionally lead to liver problems and confusion or agitation upon waking, with risks ranging from 10% to 80%.

Both treatments carry risks but are commonly used in medical settings. Understanding these potential side effects can help in deciding whether to participate in a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about exploring inhalational vs. intravenous anesthesia because these methods offer different advantages for surgery patients. Intravenous anesthesia, using propofol, is known for its rapid onset and ease of control, which can be especially beneficial for quick procedures. On the other hand, inhalational anesthesia, with sevoflurane, provides smooth maintenance and quick recovery, often resulting in less post-operative nausea. By comparing these methods directly, researchers hope to pinpoint which approach offers better outcomes in specific surgical settings, potentially leading to more tailored anesthesia practices.

What evidence suggests that this trial's treatments could be effective for reducing postoperative delirium and cognitive dysfunction in older adults?

This trial will compare two anesthesia methods: intravenous anesthesia using propofol and inhalational anesthesia using sevoflurane. Research has shown that propofol, administered through an IV for anesthesia, is effective and safe for both sedation during procedures and general anesthesia. Some studies suggest that propofol may also improve sleep quality after surgery. Conversely, sevoflurane, inhaled for anesthesia, is also effective and safe. Research indicates that sevoflurane might lead to quicker recovery and be more cost-effective due to reduced medication use. Both propofol and sevoflurane are well-regarded anesthetics, each offering unique benefits for patient outcomes. ^{1 3 4 5 6}

Who Is on the Research Team?

Katie Schenning, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for men and women aged 75 or older who are proficient in English, scheduled for elective non-cardiac surgery lasting at least 2 hours under general anesthesia. They must have good vision and hearing, an informant to verify their cognitive status, and no recent surgeries. Excluded are those with urgent surgeries, certain medical conditions like dementia or major psychiatric diseases, allergies to the study drugs, or a history of substance abuse.

Inclusion Criteria

Proficient in spoken and written English

I am 75 years old or older.

You can see and hear well enough to do all the tests.

Exclusion Criteria

You are allergic to propofol or sevoflurane.

I need surgery that requires being fully asleep with special monitoring.

I am scheduled for or had surgery with anesthesia within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous or inhalational anesthesia during non-cardiac surgery

Surgery duration

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for delirium and cognitive dysfunction in the PACU and twice daily on postoperative days 1-3

3 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for cognitive and functional outcomes, and blood biomarkers are assessed at 3 months and 12 months postoperatively

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Propofol
• Sevoflurane

Trial Overview

The trial aims to see if intravenous anesthesia (IV) with Propofol is better than inhalational anesthesia (GAS) with Sevoflurane in reducing postoperative delirium and cognitive dysfunction among older adults after non-cardiac surgery. It's a single-center study where participants are randomly assigned to one of the two groups in a double-blind fashion.

How Is the Trial Designed?

Group I: Intravenous Anesthesia Active Control 1 Intervention

Intravenous maintenance of anesthesia group using propofol

Group II: Inhalational Anesthesia Active Control 1 Intervention

Inhalational maintenance of anesthesia group using sevoflurane

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a study of 344 uncooperative children undergoing dental treatment with intravenous sedation using propofol, the most common complication was decreased oxygen saturation, affecting 25 children (7.3%).

Risk factors for complications included coughing during treatment and longer treatment duration, with 10.2% of cases experiencing temporary interruptions due to coughing, but no serious complications were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of deep intravenous propofol sedation in the dental treatment of children in the outpatient department. Wu, X., Liu, Y., Li, B., et al.[2023]

In a study of 194 children undergoing surgery, the combination of propofol and sevoflurane resulted in faster recovery times and more stable vital signs compared to sevoflurane alone, indicating enhanced safety and efficacy in pediatric anesthesia.

The use of both anesthetics significantly reduced the incidence of postoperative agitation, nausea, and vomiting, making it a safer option for children, especially those aged 6 years and younger.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison analysis of safety profiles and identification of risk factors for postoperative adverse reactions: propofol versus sevoflurane in pediatric anesthesia. Xu, X., Liu, H., Yang, J., et al.[2023]

In a study of 53 patients undergoing breast cancer surgery, propofol anesthesia did not cause greater endoplasmic reticulum (ER) stress in cancer cells compared to sevoflurane anesthesia, indicating similar safety profiles regarding ER stress.

Both anesthesia types resulted in comparable levels of CHOP expression in lymphocytes and similar neutrophil-to-lymphocyte ratios, suggesting that the choice of anesthesia may not significantly impact immune response during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of equipotent doses of propofol and sevoflurane on endoplasmic reticulum stress during breast cancer surgery. Oh, CS., Hong, SW., Park, S., et al.[2023]

Total intravenous anaesthesia (TIVA) is gaining interest in paediatric anaesthesia, but its application in children is limited, leading to potential risks if adult practices are applied without critical evaluation.

While inhaled anaesthetics like sevoflurane are safer due to fewer cardiovascular side effects, intravenous methods using propofol can lead to complications such as pain on injection and the risk of propofol-infusion syndrome, especially in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Paediatric anaesthesia: inhaled or intravenous technique?]. Jöhr, M.[2006]

A systematic review of four randomized controlled trials involving pediatric anesthesia found no significant difference in perioperative respiratory adverse events between inhalational and intravenous induction methods.

However, inhalational induction was associated with a higher risk of respiratory adverse events in children with multiple risk factors, suggesting that careful consideration is needed when choosing induction methods for at-risk pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory and hemodynamic perioperative adverse events in intravenous versus inhalational induction in pediatric anesthesia: A systematic review and meta-analysis. Porter, LL., Blaauwendraad, SM., Pieters, BM.[2021]

In a study of 300 children aged 0 to 8 years at high risk for respiratory complications, those who received intravenous propofol had a significantly lower incidence of perioperative respiratory adverse events compared to those who received inhalational sevoflurane (26% vs. 43%).

The use of intravenous propofol also resulted in fewer respiratory adverse events during induction (11% vs. 32%), suggesting that propofol may be a safer option for anesthesia induction in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhalational versus Intravenous Induction of Anesthesia in Children with a High Risk of Perioperative Respiratory Adverse Events: A Randomized Controlled Trial. Ramgolam, A., Hall, GL., Zhang, G., et al.[2019]

Both sevoflurane inhalation anesthesia (IA) and total intravenous anesthesia with propofol (TIVA) are safe options for general anesthesia, showing low rates of vital sign complications with no significant differences between the two methods.

Patients receiving inhalation anesthesia experienced significantly shorter recovery times compared to those under total intravenous anesthesia, although they had a higher incidence of nausea and vomiting, indicating that inhalation may be preferable for quicker recovery despite the need for additional anti-nausea medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol based total intravenous anesthesia versus sevoflurane based inhalation anesthesia: The postoperative characteristics in oral and maxillofacial surgery. Şimşek, HO., Kocatürk, Ö., Demetoğlu, U., et al.[2020]

In a randomized clinical trial involving 302 patients undergoing neurosurgery, inhalation anesthesia with sevoflurane/remifentanil did not significantly reduce emergence time compared to intravenous anesthesia with propofol/remifentanil, with both groups reaching an Aldrete score of 9 in similar times.

While sevoflurane showed faster times for opening eyes and extubation, it was associated with more frequent hypotension, and overall, there were no significant differences in adverse events or brain relaxation scores between the two anesthesia methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergence times are similar with sevoflurane and total intravenous anesthesia: results of a multicenter RCT of patients scheduled for elective supratentorial craniotomy. Lauta, E., Abbinante, C., Del Gaudio, A., et al.[2018]

In a study of 1538 patients who underwent gastric cancer surgery, propofol-based total intravenous anesthesia (TIVA) did not show a significant difference in 1-year overall mortality compared to inhalation anesthesia, indicating similar safety profiles for both methods.

The risk of 1-year cancer-related mortality was also comparable between the TIVA and inhalation anesthesia groups, suggesting that the choice of anesthetic may not impact long-term cancer outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of 1-year mortality after gastric cancer surgery: Total intravenous anesthesia versus volatile anesthesia. Oh, TK., Kim, HH., Jeon, YT.[2020]

In a study of 90 lung cancer patients undergoing lobectomy, propofol total intravenous anesthesia resulted in lower levels of inflammatory cytokines IL-6 and IL-8 compared to sevoflurane inhalation anesthesia, indicating a reduced inflammatory response during surgery.

Propofol also maintained higher levels of IL-10, an anti-inflammatory cytokine, throughout the perioperative period, suggesting it may better modulate cytokine balance and be a safer anesthetic option for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of sevoflurane inhalation anesthesia only and propofol total intravenous anesthesia on perioperative cytokine balance in lung cancer patients]. Hu, XL., Tang, HH., Zhou, ZG., et al.[2018]

In a study of 312,985 cancer surgery patients, there was no significant difference in overall survival between those who received propofol-based total intravenous anesthesia (TIVA) and those who received inhalational anesthesia (IA), suggesting that the type of anesthesia does not impact long-term outcomes after surgery.

While some single-center studies indicated a potential survival advantage for TIVA, multicenter studies did not support this finding, highlighting the need for further research to clarify the relationship between anesthesia type and cancer surgery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Propofol-based Total Intravenous Anesthesia Versus Inhalation Anesthesia on Long-term Survival After Cancer Surgery in a Nationwide Cohort. Yoon, S., Jung, SY., Kim, MS., et al.[2023]

Sevoflurane inhalation sedation significantly shortens the duration of endotracheal intubation and total hospital stay compared to propofol intravenous sedation, based on a meta-analysis of 7 randomized controlled trials involving 537 postoperative patients.

Sevoflurane also appears to provide better myocardial protection, as indicated by lower cardiac troponin T levels within 12-24 hours after ICU admission, without increasing the risk of nausea, vomiting, or delirium compared to propofol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sevoflurane inhalation sedation could shorten the duration of endotracheal intubation and the total length of hospital stay of critical patients after surgery as compared with propofol intravenous sedation: a Meta-analysis of 537 patients]. Wu, Y., Wang, Y., Shen, F., et al.[2019]

In a study of 68 patients undergoing corrective lower limb osteotomy, propofol-based total intravenous anesthesia (TIVA) showed significantly better physical independence and lower nausea scores compared to desflurane-based inhalational anesthesia in the early postoperative period.

While global quality of recovery scores were similar between the two anesthesia methods, the reduced nausea and lower need for rescue antiemetics in the TIVA group suggest it may be a preferable option for enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhalational versus intravenous maintenance of anesthesia for quality of recovery in patients undergoing corrective lower limb osteotomy: A randomized controlled trial. Kim, SH., Ju, HM., Choi, CH., et al.[2021]

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