Clinical Research Trials 

The Department of Anaesthesia, Perioperative Medicine & Pain Management Research Unit is involved in a number of collaborative research studies.

IV Iron for Treatment of Anaemia before Cardiac Surgery (ITACS)

The aim of this study is to determine whether a single dose of iron as an intravenous infusion administered in the Pre-Admission Clinic given to anaemic patients before their planned cardiac surgery improves patient recovery, reduces serious complications, facilitates earlier hospital discharge and is cost-effective.

 

Anaemia is common in preoperative cardiac surgery patients and is associated with increased complications, increased length of ICU and hospital stay, and mortality.

 

At the end of this study we will have information to establish whether a preoperative single dose

iron infusion in preoperative cardiac patients is beneficial and cost-effective.  (ALFRED HEALTH ONLY) All patients at the Alfred will be involved in a substudy to identify more appropriate measures of iron deficiency and predict responsiveness to iron therapy in patients with heart disease.

 

Medication, drugs and devices have to be approved for use by the Therapeutic Goods

Administration (TGA) of the Australian Federal Government. Iron (ferric carboxymaltose) is

approved in Australia to treat iron deficiency anaemia. The syringe and tubing used to deliver the drug or placebo have not been evaluated by the TGA and so their use in this study is therefore considered experimental. The syringe and tubing have been used in several previous studies without problem.

 

This research has been initiated by the study doctor, Professor Paul Myles of Alfred Health.

 

 This research has been funded by The Australian National Health and Medical Research

 Council.

 
Reduction Of Chronic post-surgical pain with Ketamins (ROCKet)

What is the ROCKet trial?

The ROCKet (Reduction Of Chronic post-surgical pain with Ketamine) Trial is a multicenter, double-blind, parallel group, placebo controlled, randomized trial of the effect of perioperative ketamine on the risk of development of chronic post-surgical pain.

 

 

What is chronic post-surgical pain?

Chronic postsurgical pain (CPSP) is a common and debilitating complication of major surgery. CPSP is loosely defined as: pain persisting at least three months after surgery; pain not present before surgery or that has different characteristics or increased intensity from preoperative pain; pain localized to the surgical site or a referred area.

 

Why use ketamine?

Parenteral perioperative ketamine administration has been identified as having a role in preventing CPSP. As an NMDA receptor antagonist, ketamine has been shown to have anti-hyperalgesic effects.

 

Why are we doing this trial?

We hypothesize that intravenous ketamine given prior to and following surgical incision for up to 72 hours will reduce the incidence of CPSP.

The Post Anaesthesia N-Acetyl-Cysteine Evaluation trial (PANACEA)

 

Patients having non- cardiac surgery at the University Hospital who are over the age of 60 years will be included in this trial. The research project is testing a medication that may be able to prevent a condition known as Post-Operative Cognitive Dysfunction, or POCD.

 

POCD is a condition where a person who has undergone surgery can sometimes experiences changes to their memory, mood, and other cognitive areas. While often short in duration, POCD can sometimes remain for years. At present, there are no medicines available to prevent or treat POCD. The medicine we are investigating is called N- Acetyl-Cysteine, or NAC for short.

NAC is approved in Australia by the Therapeutic Goods Administration to treat overdoses of paracetamol, or Panadol. NAC is also be used to treat bronchitis. However it has not been used to prevent POCD. Therefore, its use for POCD is experimental. This means that it must be tested to see if it is effective. While NAC has been widely studied for many different conditions, this is the first major study of the effects of NAC on POCD in humans.  This project will help us understand the causes of POCD, any details about a person that makes them more likely to experience POCD, and provide important information about how we can treat POCD.

 

Although POCD is not entirely understood, there are theories about how it happens. One of the theories is that POCD can be caused by the physical stress the body experiences when having surgery. NAC is a type of medicine known as an antioxidant, and can help reduce the type of stress the body experiences when having surgery.

This study aims to recruit 370 participants. Patients of University Hospital Geelong will be approached and invited to participate. Half of the participants in this study will receive NAC, and the other half will receive a placebo.  This study is a collaborative effort between Barwon Health and Deakin University.

The Perioperative Administration of Dexamethasone and Infection trial (PADDI)

Patients having a general anaesthetic, non-cardiac surgery (duration of at last two hours or more) and at least two postoperative nights stay in hospital will be included in this study.  The research project is testing whether the commonly used treatment for prevention of postoperative nausea and vomiting has an effect on wound infection.

Medications, drugs and devices have to be approved for use by the Australian Federal Government. Dexamethasone is approved in Australia to treat allergic and inflammatory conditions.

Nausea and vomiting are common complications of general anaesthesia. Sometimes nausea and vomiting can be very severe and unpleasant. There are a number of drugs that anaesthetists give to patients in order to prevent nausea and vomiting. One of these is a drug called Dexamethasone.

 

Dexamethasone is a very effective agent for preventing nausea and vomiting. However, it is from a class of drugs called corticosteroids, which may affect blood sugar and the way our immune system works. We know from our previous research that almost half of patients undergoing general anaesthesia in Australia and New Zealand will receive a dose of Dexamethasone during their surgery. The purpose of this study is to determine whether the use of this drug is associated with more or less infections after surgery. At this time we are not sure why the immune system is affected, hence we are doing this study. Some research suggests that Dexamethasone increases the risk of developing infection after surgery, but other research suggests that it may in fact decrease the risk of infection. We need to undertake this study to find an accurate answer.

 

At the end of this study we will have enough information to determine whether the use of dexamethasone during anaesthesia is associated with a change in the rates of infections after surgery. This information will then be used by doctors around the world to improve treatment.

 

This research has been funded by the National Health and Medical Research Council of Australia.  This research is being conducted by the Alfred Hospital, Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Network, located at Monash University together with the Australian Society of Infectious Diseases (ASID) clinical research network.

In total there will be 8,880 participants taking part in the study in 3 countries around the world. Half of these patients will receive dexamethasone and half will receive a placebo.

Restrictive versus Liberal Fluid Therapy in Major Abdominal Surgery (RELIEF)

Patients of University Hospital Geelong undergoing abdominal surgery will be invited to participate in this study.  The research project is aiming to identify the optimum fluid regimen for patients having major abdominal surgery.

When a patient has been fasting or when there has been some fluid or blood loss from surgery patients often have to be treated with extra fluids to replace the fluid loss. There are no standard ways for giving fluids to patients during and after surgery.

 

Anaesthetists, surgeons and intensive care doctors can sometimes differ in their choice of how much or what type of fluid to give patients after surgery. The evidence for the best way to decide on how much fluid to give patients after surgery is insufficient to guide our practice.

The information we have from around the world, about the best amount of fluid to be administered to a patient undergoing major surgery, is based on small studies and is not supported by strong evidence. At this time we are unsure whether it is better to give more or less fluid during and after surgery. Practices vary substantially, guidelines are vague, and a lot of the available information is contradictory. A large, definitive clinical trial evaluating perioperative fluid replacement in major surgery is required to answer these questions.

 

At the end of this study we will have enough information to identify what is the best amount of fluid for individuals to receive when undergoing major abdominal surgery. This information will then be used by doctors around the world to improve treatment.

 

This research has been funded by the National Health and Medical Research Council of Australia and is being conducted by the Australian and New Zealand College of Anaesthetists (ANZCA) Trials Group together with the Australian and New Zealand Intensive Care Society (ANZICS) clinical trial group.

In total there will be 2800 participants taking part in the study from 6 countries around the world. 1400 patient will receive less fluid and the remaining will receive more fluid.

The Influence of Anaesthetic Depth on Patient Outcome after Major Surgery (BALANCED)

 

This research project will include patients 60 years and over who are having surgery that requires a general anaesthetic. The research project is testing whether the depth of general anaesthesia has an important effect on patient outcomes after major surgery.  Currently there are no guidelines on the most appropriate depth of anaesthesia to choose during surgery.  

 

In this study we will compare two levels of anaesthetic depth and determine whether the depth of general anaesthesia has an important effect on patient outcomes after major surgery.

 

During surgery your vital signs, such as heart rate, blood pressure and oxygen levels, are closely monitored and controlled by your anaesthetist. Monitoring devices have also become available that allow anaesthetists to measure patients’ brain waves during general anaesthesia. Using these devices, anaesthetists are able to precisely adjust the amount of anaesthetic medication a patient is given and therefore control how deeply asleep their patient is during surgery.  However, the best anaesthetic depth for patients during surgery is unknown.

 

6,500 patients will participate in this study in about 50 hospitals in Australia, New Zealand, Hong Kong and other countries around the world. About 200 patients will take part at Barwon Health.

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