Clinical research studies in the department of anesthesia

These are voluntary research studies for which you may be approached for participation. If you are not interested you can decline involvement when contacted by research assistants, through anesthesia.research@sw.ca or by calling our research office at 416-480-6100 ext. 689607.

CODEX: Cognitive Outcomes after Dexmedetomidine Sedation in Cardiac Surgery Patients

Postoperative cognitive dysfunction (POCD) is thought to affect a significant proportion of patients after all types of surgeries (up to 10% at 3 months) while cardiac surgeries appear to carry the highest risk. This is a condition that can occur after surgery and anesthesia affecting memory and thought processes. While it is widely assumed that cognition returns to baseline after anesthetics have been eliminated, many patients have persistent memory impairment for weeks to months after surgery. There are no proven preventative or treatment strategies that can reduce the incidence. In this research study we investigate whether the addition of Precedex to usual postoperative care reduces the incidence of POCD three months after surgery and enhances early postoperative recovery in those undergoing open cardiac surgery. This drug is used in clinical practice as a sedative and analgesic. The results of this trial will provide an insight on the efficacy of Precedex in reducing the incidence of POCD after anesthesia and may lead to identification of the first POCD preventative therapeutics.

PROMoTE: Redesigning the Surgical Pathway: Optimizing Preoperative Assessment in Anesthesia Clinic for Adult Surgical Patients

Postoperative delirium (POD) is a state of confusion or ‘brain fog’ that commonly occurs in patients after surgery (up to 10-50%). Patients who have pre-existing cognitive impairments are at a higher risk of developing POD. The aim of this study is to identify patients at risk for delirium using cognitive screening and test the effectiveness of a simple no-medication approach for preventing POD.

Effect of a Pre-Operative Internet-Based Educational Video, Providing Both Opioid Counselling and Pain Coping Skills, on Post-Operative Opioid Consumption

After hip or knee replacement surgery, most people experience pain, for which they may be given certain medications, including a type of painkiller known as opioids. Taking too many opioids after surgery can be dangerous, slow down recovery and lead to addiction. Also, for many patients these medications will not be enough to completely control their pain. Therefore, it is important to teach patients how to use opioids safely and to find other ways to control pain after surgery. Our study uses an online video which teaches patients both how to safely use opioids and other healthy ways to deal with pain, such as breathing exercises. We are investigating if this video can help to lower pain and the amount of opioids needed after surgery. We will also look at how patients recover after surgery, including any complications and how much time they spend in the hospital. If successful, this video will help patients to better control their pain after hip or knee replacement surgery.

SAVE-ICU: Sedating with Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects on Ventilatory Parameters and Survival

Some critically ill patients, including many patients with COVID-19, require the help of a machine called a mechanical ventilator to help them breath. All patients needing a ventilator also need sedation (or sleep-inducing medications) to keep them calm and comfortable during this process. These medications are usually given through the vein (intravenous or IV), however, when the IV sedatives are stopped after a long period of time, it can take time for the drugs to leave the body, making it harder for patients to wake up, and increasing the chances of complications.

Another way to provide sleep is by using inhaled sedatives, which are breathed in through the breathing tube that is connected to the ventilator. These drugs have several possible benefits for patients which may allow them to recover faster. In this study, we are comparing these two forms of sedation for critically ill patients in the ICU who require mechanical ventilation.

PENTOCLO: Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible (PENTOCLO), a Pilot Randomized Control Trial

Radiation is commonly used to treat cancer in the head and neck, however, this can lead to a serious complication called osteoradionecrosis (ORN), where there is necrotic (dead) open bone inside or outside of the mouth. This complication is difficult to treat using usual methods, can have devastating effects on quality of life, and requires large amounts of healthcare resources.

Two common ways to treat ORN are hyperbaric oxygen (HBOT), which uses high concentrations of oxygen in special chambers and requires up to 60 treatments at a specialized clinic; or a less complex option called PENTOCLO which involves several antibiotics followed by a combination of other medications taken for at least 1 year.

In our study we will test if the combination of HBOT and a modified version of PENTOCLO together is better than the current standard treatment of HBOT alone. We will look at ORN healing, ORN symptoms (e.g. pain, dry mouth), side effects and the need for surgery. Specifically, the results of this small study will help to inform the design of a future large, controlled trial.

HEROES: Hyperbaric oxygen therapy for endometriosis-related pain

People with endometriosis often have severe pain in their pelvis that requires medical treatment. This treatment sometimes involves surgery, which can have long wait times of more than one year. We are studying a new therapy, called hyperbaric oxygen therapy, to treat endometriosis-related pain while patients are waiting for their surgery. Hyperbaric oxygen therapy involves placing patients in a small chamber where they are treated with high levels of oxygen gas. This technique has been helpful for other causes of pain, but has not been studied for endometriosis. Our study has the potential to improve treatment for endometriosis-related pain, and better the lives of many patients.

PCS-HBOT: Improving Post-COVID Syndrome with Hyperbaric Oxygen Treatments

Over 500 million people worldwide have been infected with COVID-19 and more than 6 million people have died. Many people who have recovered from COVID-19 continue to suffer from symptoms even after they have been “cured” of the disease. This is known as post COVID-19 condition and can have serious health consequences. One common symptom is fatigue, which is a feeling of tiredness or lack of energy. We are studying a new way to treat symptoms of post COVID-19 condition, called hyperbaric oxygen therapy. Hyperbaric oxygen therapy involves placing patients in a small chamber where they are treated with high levels of oxygen gas. This has been helpful for treating some other causes of fatigue. However, this treatment is expensive and time consuming and so our ability to test this treatment in a large research study is unknown. This small study will help us to decide if it is possible to do a full research study to find out if hyperbaric oxygen therapy improves symptoms of post COVID-19 condition, such as fatigue.

UNPIN: Ultrasound-guided percutaneous intercostal nerve cryoneurolysis for analgesia following traumatic rib fracture, a pilot randomized control trial

Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They can also lead to serious complications, more time spent in hospital, and can even cause death. 48% of individuals with traumatic rib fractures experience significant complications and 22% of participants greater than 60 years old die. Rib fractures prevent patients from taking deep breaths to keep a healthy level of oxygen in the blood and increase the risk of pneumonia. Even after rib fractures have healed, they can lead to long-term pain and lower quality of life. The technology for cryoneurolysis, or freezing of nerves, has become available in Canada and is a promising tool for managing rib fracture pain. This study is a pilot (small) study to assess whether it is feasible to use this technology for patients with rib fractures. If proven effective, cryoneurolysis can provide effective, immediate, and long-lasting pain relief. This could potentially minimize the short and long-term complications of this common injury, improve patient care, and reduce costs for our health care system.

Positioning of continuous adductor canal catheters after total knee arthroplasty (CACB)

Total knee replacement is a common surgical procedure used to treat a variety of conditions such as osteoarthritis involving the knees. Good pain control is important for patients, as it reduces complications and the need for opioid medications. Currently, doctors use a method called ultrasound-guided continuous adductor canal block (CACB) during and after surgery. This involves putting a small tube called a catheter in the thigh to deliver pain medication directly to the site of pain, and is a standard method for providing pain control during and after the knee replacement procedure. However, sometimes the catheter can move out of place after insertion, which makes it less effective in controlling pain.

The purpose of our study is to use an ultrasound device to check if the tube that delivers pain medication is working properly. We also want to see how well this specific type of pain relief method (CACB catheter) works after surgery. Our study can help to improve patient pain relief, reduce costs for our healthcare system by decreasing opioid use and possibly shortening hospital stays.

RELIFE: Effect of perioperative duloxetine administration on opioid consumption following total knee arthroplasty

One important way to control pain after knee replacement surgery is using opioid pain medications. However, these medications can also lead to complications. Therefore, other pain treatments are needed. Duloxetine is an antidepressant medication that also helps to directly treat pain, and which has been Health Canada approved for specific types of knee pain. In this study, we are testing if adding duloxetine to standard pain management protocols, helps to reduce pain and the need for opioid pain medications after knee replacement surgery. Participants in our study will take Duloxetine or a placebo every day for 2 weeks before their surgery and for 6 weeks after. They will then be followed for 12 weeks after their surgery to look at pain levels and the need for opioids.

Our collaborations:

CHAMP: Comprehensive Health Assessment for My Plan: initial implementation study

Older adults often have chronic health conditions such as heart disease, diabetes and cancer. They are at a higher risk of side effects and complications after surgery because of poorer health. Surgeons and anesthesiologists must decide if an older adult is fit enough for surgery. Because of this, a Geriatric Assessment which identifies risk factors in a way that is specific to older adults, is important before surgery. This information can help the surgical team and the older adult to implement measures to optimize the patient’s health before surgery to reduce the risk of complications. However, doctors often cannot complete this assessment because of a shortage of time, resource or training. In this study we are testing an electronic geriatric self-assessment, called CHAMP, which includes specific tools for assessing risk factors in older adults and makes recommendations for both patients and doctors about the specific risks of older patients. If successful, this will give doctors the necessary information to make the best decisions for their older patients, and help to prevent poor outcomes and complications after surgery.

FAST Walk: Functional assessment for surgery by a timed walk

It is very important to understand which patients are likely to experience complications after surgery, as this can lead to future problems. The aim of this study is to determine whether the results of a short walking test called the 6-Minute Walk Test and some other simple tests can help identify who is more likely to experience health complications at one month and three months after surgery. The results of this study will help doctors to keep patients informed and prevent complications after surgery.

ALOFT: Anesthesia for Lower limb revascularization to Optimize Functional ouTcomes

Narrowing or blockages in the arteries that supply blood to the legs often requires surgery to improve circulation and prevent complications. There are currently two anesthesia techniques being used for this type of surgery - general anesthesia, where medications are given so that the person is unconscious during the surgery and neuraxial anesthesia, where anesthetic “freezing” medications are injected into the lower back to numb the body from the waist down. Typically, sedative medication is also given with this type of anesthesia to help the person relax and sleep during the surgery. This study is comparing these two types of anesthesia to determine which one is better for people having surgery to repair narrowed or blocked arteries in their legs.

FIT AFTER SURGERY: The Functional Improvement Trajectories After Surgery Study: A Multicentre Prospective Cohort Study to Evaluate the Incidence, Trajectories, Risk Factors, Impact and Healthcare Costs Related to Significant New Disability after Major Elective Surgery

All major operations have some risks of complications. Especially in people older than 65 years, these complications can sometimes mean that a person will have major disability such as difficulty in taking care of themselves and socializing with family and friends for several months after surgery. At present, doctors cannot easily identify which patients are more likely to develop major disability after surgery. The purpose of this study is to measure how often disability occurs after major surgery, and to identify what types of people are more likely to suffer from disability. This research is being done to help improve care for future older patients who are having surgery.

Self-BAT: Does the Self-administered Bleeding Assessment Tool Score Accurately Predict Perioperative Bleeding?

Bleeding assessment tools (BATs) are often used to assess patients’ bleeding history and require a nurse or physician to complete the screen. Recently, a bleeding assessment tool, Self-BAT, was created allowing patients to complete the screen without help. This tool has been used to identify a common bleeding disorder called von Willebrand Disease. This study aims to determine if scores on the Self-BAT can predict major bleeding disorder during and after surgery.

PLAN: Prevention of Persistent Pain with Lidocaine Infusions in Breast Cancer Surgery

Surgery is a critical part of breast cancer treatment. A common complication after breast cancer surgery is persistent pain that does not go away after the expected time needed to heal from a surgical procedure (e.g. 3 months). While there are no known interventions that prevent persistent pain after breast cancer surgery, there is published research suggesting that an infusion of lidocaine during surgery can prevent the development of persistent pain. The purpose of this study is to determine if giving lidocaine as an infusion during breast cancer surgery will reduce the amount of pain a patient has when recovering from surgery. This will help us to find out if using lidocaine is better than the current way of managing pain after surgery for breast cancer.

Thank you and best wishes for your upcoming surgery.
On behalf of the department of anesthesia at Sunnybrook, Perioperative Brain Health Centre and our team of healthcare professionals.
For more information, please visit: www.perioperativebrainhealth.ca.