top of page
Search
  • Writer's pictureJehshua Karunakaran, MD

Awakening the Patient: Addressing Intraoperative Consent in Awake Neurosurgery

Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be cognitively able – or competent – to make a voluntary decision about whether to undergo the procedure or intervention (Shah et al, 2023). Although various legal cases established the notion of consent in the early 20th century, the term began being used in the post-WWII years when the Nuremburg trials in 1947 investigated 23 Nazi physicians and political leaders for war crimes pertaining to the use of humans in medical experimentation. As a result of that trial, a set of guidelines was set forth to govern future human medical experimentation that became known as the Nuremburg Code (Bazzano et al., 2021).


Since then, informed consent has been a mainstay of medical care. Surgical informed consent involves discussing ALL the risks and benefits of the procedure, as well as if there’s a possibility that while during the surgery it becomes apparent that a more complex procedure needs to be performed. A patient must demonstrate their ability to understand everything being told to them, as well as show mental cognizance and awareness - a concept known as “capacity”.


Capacity refers to the ability to utilize information about an illness and proposed treatment options to make a choice that is congruent with one's own values and preferences.

In episode 2, we consider the role of informed consent in a subset of surgeries known as “awake surgeries”. These procedures include neurosurgical procedures that require patients to be brought out of sedation in the middle of the operation in order to monitor their real-life voluntary responses to the surgery. One such procedure is deep brain stimulation (or DBS for short) in which an electrical pacemaker is implanted into the back or chest of a patient, with a small electrical lead extending from it and delicately threaded up into the deeper parts of the brain to deliver controlled electrical impulses. The concept is that inducing impulses via the tip of the electrical wire will help correct neuronal misfiring that leads to pathologies like seizures and Parksinon’s disease, much like an electrical engineer fixes a blown fuse or short circuit in a house by rewiring the circuit or replacing the fuse. It has been in practice for many decades now, and is an extremely effective treatment for reducing tremors and giving people with advanced Parkinson’s disease a new lease on life. During these operations, patients are awakened mid-surgery to ensure that the electrical lead is not inadvertently affecting unintended parts of the brain. They are asked to speak, sing, read, maybe even play an instrument, or do tasks that are routine to them to test that they continue to function normally in all areas aside from the target zone. If the electrical lead is misplaced, patients will have altered motor or sensory experiences, and describe feeling “different” or be unable to perform what is asked of them. In that case, the wire is repositioned until the patient returns to their functional baseline with only the desired therapeutic effect being demonstrated.


Consent is typically obtained immediately prior to surgery - except in life-saving emergency cases where there is no decision-maker present. In “awake surgeries”, the same protocol is followed; however, the act of waking patients up in the middle of surgery leads to the possibility of patients deciding to change their mind about continuing with the procedure. Indeed, in our interview with Dr. Paul Ford, he shares a story of that exact situation happening in a case for which he was consulted almost two decades ago (Ford et al., 2007). In these cases, many questions arise: how should the surgeon proceed? Is the patient fully capable of revoking consent intra-operatively? What does sedation, stress, and the OR environment do to a patient’s capacity? Are patients allowed to preemptively tell doctors to deny their request to intraoperatively withdraw consent (i.e. to revoke their right to revoke consent)?


 

The last question was addressed handily by Dr. Ford in our podcast; but many of these other issues deserve further discussion. For example, when patients are awake intraoperatively, attendings feel reluctant to correct residents and point out notable medical findings, and residents feel awkward asking questions to enhance their learning (Smith et al., 2019). Additionally, patients are sometimes confused about the role of residents in the operating room, their medical qualifications, and their oversight, leading to some patients declining resident involvement in their care. Furthermore, there lies the question of altered awareness and perception - in any brain surgery, there is a possibility that invading the deeper gray matter with electrical probes may alter a patient’s psychological state. This is especially true when DBS is used to help manage underlying psychiatric issues like depression or substance addiction (Sui et al., 2021). How do we know that when the patient is brought out of anesthesia, that they are fully aware and capable of making an informed decision about their care? On the flip side, being aware that someone is literally probing your brain leads to a state of vulnerability, where patients might not feel comfortable disagreeing with their physician about their care out of fear that the surgeon may do a lousy job.


So what can physicians do to address these concerns? Our goal here isn't to advise that every question above be resolved with the advice of a bioethicist - there should be workarounds that are physician-patient centered that don't require outside inputs. In fact, most such complications of the OR environment can be mediated by good communication and trust between patients and their physicians. A recent study conducted by a group of physicians and bioethicists demonstrated that there are often gaps in understanding and values between operating physicians and their patients, especially when it comes to intraoperative research (Smith et al., 2023). Concepts get lost in translation during consent procedures, leading to patient-doctor misunderstandings that then surface during the awake portions of the surgery. Indeed, during our own medical training, we (the hosts of this podcast) often witnessed rushed preoperative consents, which when coupled with the normal stress of patients about to undergo surgery, would sometimes leave patients blank-faced. This is not just isolated to surgeons and informed consent issues; numerous studies have shown that open communication with patients leads to fewer malpractice suits and better overall patient outcomes. In an era where there is distrust of the healthcare establishment and doctors and patients often butt heads, there is a higher likelihood of patient anger when things don’t go as they expect it to go because of a lack of transparency and communication.


To broaden the scope of this discussion, experimentation and observation are the cornerstones of medical advancement across all specialties, so it is not uncommon for some procedures to include experimental portions of the operation (e.g. new target zone neurostimulation, novel surgical approach and dissection, etc.). Consent is always obtained for these experimental things prior to surgery, but again, in awake procedures, the patient may withdraw consent in the middle of the treatment. It is crucial at this point to be able to address the patient's concerns, assess capacity, and ensure that if they truly want to end the procedure that it can be done without harming them. Remember that surgery is not a benign treatment - it is "controlled injury" that is done with the hope that the benefits of surgery outweigh its risks. But when an operation is stopped after having been begun, there is a risk that the injury was done without the corresponding benefit. So it is imperative to make that assessment and discuss it briefly with the patient should that situation arise.


From a patient perspective, it is important to know that most bioethicists agree that you cannot sign a Ulysses Contract - a contract in which you bind yourself to follow through with a medical procedure even if you change your mind later. So your right to revoke consent always stands as your right, and no medical provider should be coercing you into giving that up. It is always best practice to have an open conversation about your concerns and discuss potential safe exit strategies should you have a change of mind intra-procedure.


We may discuss more of these issues in future episodes, so stay tuned! In the meantime, feel free to look at the bibliography below if you want to do a deeper dive. Thanks for reading, and as always, let us know your thoughts and comments through email or on our social media platforms!



Bibliography


  1. Bazzano, Lydia A et al. “A Modern History of Informed Consent and the Role of Key Information.” Ochsner journal vol. 21,1 (2021): 81-85. doi:10.31486/toj.19.0105

  2. Ford, Paul J et al. “A patient revoking consent during awake craniotomy: an ethical challenge.” Neuromodulation : journal of the International Neuromodulation Society vol. 10,4 (2007): 329-32. doi:10.1111/j.1525-1403.2007.00119.x

  3. Peabody Smith, Ally et al. “"They were already inside my head to begin with": Trust, Translational Misconception, and Intraoperative Brain Research.” AJOB empirical bioethics vol. 14,2 (2023): 111-124. doi:10.1080/23294515.2022.2123869

  4. Shah P, Thornton I, Turrin D, et al. Informed Consent. [Updated 2023 Jun 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430827/

  5. Smith, Claire S et al. “Resident Perspectives on Teaching During Awake Surgical Procedures.” Journal of surgical education vol. 76,6 (2019): 1492-1499. doi:10.1016/j.jsurg.2019.04.007

  6. Sui, Yanan et al. “Deep Brain Stimulation Initiative: Toward Innovative Technology, New Disease Indications, and Approaches to Current and Future Clinical Challenges in Neuromodulation Therapy.” Frontiers in neurology vol. 11 597451. 28 Jan. 2021, doi:10.3389/fneur.2020.597451


11 views0 comments
bottom of page