Wednesday, December 16, 2009

Yet Another Person Drugged Against Their Will

Anesthesiology - Sedation & General Anesthesia without consent

Expert: Ronald Levy, M.D. - 11/20/2009

QUESTION: On October 19, 2009, I had TriVex surgery to correct Varicose veins in my leg. I consulted with the surgeon before even being a candidate for surgery and asked for a regional anesthetic. The surgeon said that would be too much anesthesia and suggested spinal anesthesia. I said I wanted to remain awake and not be sedated and wanted to have a similar experience as I did
during the C-Section birth of my child. The surgeon agreed. This is well documented in my medical record. The day of surgery I spoke with the first nurse who started my IV and told her that I was going to be awake because I was having spinal anesthesia. The nurse checked my medical record and said “You're right, you‘re having a spinal". I then consulted with the anesthesiologist, who said that he was going to put medicine in my IV to make me go to sleep. I told him no you’re not, I am having a spinal. The anesthesiologist said, ”Who says“? I told him my surgeon and I also said, “I want to be awake“. He confirmed that I was having spinal anesthesia in her medical record. The surgeon came in and marked my leg and I asked him if I could watch the procedure. He said no. The nurse anesthetist then came into the room and I told her that I wanted to be awake and made reference to my experience during child birth. I went to the operating room at 10:00 A.M. and at 10:02 A.M. the nurse anesthetist administered 1.5 mg of Midazolam and I weigh 112 pounds. The anesthesiologist told the nurse anesthetist give her ____ she is allergic to Morphine. The nurse anesthetist said I am. The last thing I remember, is the nurse anesthetist putting up a curtain near my waist and I said, “Well I guess I won‘t be able to watch“. I woke up 50 minutes later and discovered that I had been put to sleep against my consent. According to my medical record, the spinal was in at 10:09 A.M. and right after that it says Propofol was administered. TriVex is a new “minimally evasive procedure“. I also talked with a medical doctor about this incident and he said, “It is highly unlikely they gave you Propofol for varicose veins”, but it is in my medical records and they agree they gave me Propofol. On the pre-anesthesia report it says, "Patient wants SAB" spinal anesthesia and the block for Versed is not checked. All documents in my medical record list spinal and nothing else. The next day I complained to the surgery center saying that they sedated me and put me to sleep without my consent. The head nurse said they give the Midazolam because they don't want people to hear noises. The nurse anesthetist then called and I complained to her. The nurse anesthetist said she gave the Midazolam so I did not hear noises because it is too traumatic on people. I then asked why they did a spinal and used propofol and the nurse anesthetist said, “You were moving your leg“.
During a follow up visit with the surgeon he apologized and said he does not know why they sedated me. He said there were some "Oohs and Aw's" so they used propofol. The surgeon said he could have performed the surgery with only spinal anesthesia and no sedation as planned. I also got a letter from the administrator of the surgical center saying that he spoke with the anesthesia team and they agreed I wanted to be awake and apologized. I see from many articles that Midazolam is a pre-medication for Propofol. Based on the dose of Midazolam did they intend on administering Propofol all along and did the spinal to appease me and said that they tried the spinal anesthesia? I never agreed to anything other than spinal anesthesia without sedation. Why didn't they administer the spinal anesthesia and if not successful, tell me that they would have to put me to sleep? Since I am in Pennsylvania, I filled out private criminal complaints against the anesthesiologist and nurse anesthetist and have an appointment with the prosecutor on November 30, 2009, to see if he will accept the criminal charges. These acts were intentional and deliberate and I feel they violated criminal law and have alleged in the charges that they provided drugs as a practitioner beyond the scope of their authority and without my consent. Could you please answer my questions so I am clear on everything.

ANSWER: Let me try to answer your question understanding that I have to speak about the hypotheticial since I was not present for your procedure. I will try to address all of your concerns.

First some definitions. Midazolam is a anxiolytic (like Valium but shorter acting) that, in addition to its anti-anxiety effects, also has amnestic effects. Propofol is an anesthetic, but in smaller doses, is a sedative, anxiolytic and also has some amnestic properties. MAC (monitored anesthesia care) anesthesia can mean anything from no drugs at all to as much drugs as possible so long as the patient is arousable. Spinal anesthesia is a regional anesthesia technique. I assume you had the spinal done (a needle in the back). The anesthesiologist, as part of his consent, should have mentioned that there is always a possibility that the spinal may fail and they'd have to convert to general.

The procedure you had was likely done under spinal (SAB) but they did give you the Versed for the anti-anxiety properties (1.5 mg is not a large dose). While spinal anesthetics are very reliable, they don't always work and we sometimes have to supplement them when they only partially work. The easiest way to do this (while still giving a MAC anesthetic) is to use propofol. The sedative effects of Propofol along with the partially working SAB is usually enough to finish the procedure. If that fails, then general anesthesia is the only option. If your anesthetic record does not note either an endotracheal tube or an LMA, then you did not have a general anesthetic. Midazolam is not a premed for Propofol but rather an anxiolytic usually given before entering the OR. I speak from experience in that I have had wisdom teeth taken out under Midazolam and although the dentist (a friend) said I moaned and groaned, I have no memory (thankfully) of the procedure. There is no indication that they intentionally put you to sleep and I can't imagine an anethesiologist putting in a spinal just for show. In fact, anesthesiologists prefer regional anesthesia because patients can tell us if they are having chest pain, etc so it is easier to treat them. The difference between this procedure and your c-section is that for your section they wanted you to remember holding your baby for the first time so they didn't give you the Midazolam. Most anesthesiologists are hesitant to agree to a completely awake patient primarily because many patients think they want to be awake but when they get to the OR and they hear the noises and see the blood, etc. they aren't so happy any more but now the anesthesiologists hands are tied and he can't give sedation (even though you are awake and now ask for it, you are under stress and the validity of your consent may have some medicolegal implications later on).

You are certainly free to pursue legal action but my feeling is the prosecutor will be reluctant to accept the case as he will have a small chance of a conviction (if what I have said is true).

Hope this helps you and sorry for your unplesant experience,

Ronald Levy, MD
Professor of Anesthesiology

---------- FOLLOW-UP ----------

QUESTION: Dr. Levy don't you see a problem with informed consent? I specially told every medical employee (I will not call them professionals) that I came in contact with that I was only consenting to a spinal with no sedation and I wanted to be awake like I was during the birth of my child, which would include not consenting to amnesia from Midazolam. After I complained, all medical employees agreed that I wanted to be awake and apologized. I never agreed to any type of sedation, either Midazolam or Propofol or any other sedative. I was given the Midazolam and then told. Don't you see a problem with consent there? According to proper informed consent in Pennsylvania I was suppose to be told of the risks and benefits of the anesthesia. I was never advised of any risks or benefits and alternatives of any anesthesia, let alone the spinal. You don't see an ethical issue here? If you took you vehicle in for an oil change and a hour later the mechanic spoke with you and told you that your bill would be $1,200 because while it was on the lift they had to put a new transmission in and did not it without your consent. The mechanic is an expert in his field like doctors are experts in the medical field. I am sure you would be highly upset with your mechanic and that issue could be dealt with either in civil court or the mechanic could be arrested for fraud or deceptive business practices, which would be handled by the criminal justice system. This is the same issue, I did not consent to anything other than the spinal and consented to and agreed to be fully awake since I was consenting to a spinal only. They did not have a right to sedate (Midazolam) me against my will and without my consent or permission. Also I see that people who are allergic to eggs can have an allergic reaction to Propofol. They never checked this with me. It certainly seems that doctors and other medical employees do not have have ethics and feel that they can do whatever they want to their patients without being held accountable. Can you name any other profession where employees could treat the consumer like I was treated and not be held accountable or disciplined? All of this comes from someone who has worked as a medical professional for over 25 years. I appreciate your response.

As I stated in my previous response, I was not justifing what they did, I was only commenting on what likely happened. I do take offense when you say doctors and medical personnel do not have ethics, etc, based on this one event you had. Let me try to answer some of your comments and ask you a question. As for the consent, if they did not talk to you at all about the type of anesthesia, risks, complications and alternatives, then they were clearly wrong (not just in PA but throughout the world). With respect to eggs and Propofol, they should have certainly asked if you had any allergies (I'm sure someone asked you that question) and the problem with eggs has to do with the yolk and some recent studies have shown that the formulation of Propofol doesn't have the proteins common in the allergy ( but they still should have asked and many anesthesiologists probably wouldn't use it. As for other professions where employees take advantage, I think every profession has people who do that. There are bad apples everywhere but it should not speak against all people in that profession. As for suing them, you are certainly within your rights to do that. I don't think you have grounds for a malpractice suit (you don't meet the 3 criteria). A criminal suit would be tough to get a conviction (the best charge might be battery but it would be hard to prove) so your only hope would be a civil suit which may get you money but I don't think that is what you want. You could certainly notify your state medical board and they can investigate (which is probably the right thing to do) but that is up to you.

As for my 2 questions, the first is "Why are you so insistent to be awake for the procedure?" and the second and more important question is "What would you want the anesthesiologist to do if he did only the spinal and it didn't work or it did work but you had second thoughts and were now nervous and wanted sedation?". As I mentioned earlier, the only "legal" option you give the surgeon and anesthesiologist is to abort the procedure (if possible) and come back another time.

I hope I have cleared up some of your concerns,

Ronald Levy, MD
Professor of Anesthesiology