Facial Aesthetic Surgery: The Safe Use of Oral Sedation in an Office-Based Facility

Transcription

1 Facial Surgery Facial Aesthetic Surgery: The Safe Use of Oral Sedation in an Office-Based Facility Aesthetic Surgery Journal 2016, Vol 36(2) The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: DOI: /asj/sjv200 Daniel R. Butz, MD; Kiranjeet K. Gill, MD; Jasmine Randle; Natalie Kampf; and Julius W. Few, MD Abstract Background: The desire for efficient and safe office-based facial plastic surgery procedures has continued to rise. Oral sedation is a safe and effective method to provide anesthesia for facial aesthetic surgery. Objectives: This study reviewed private practice anesthesia-related outcomes using oral sedation combined with local anesthesia for office-based facial aesthetic surgery procedures. Methods: A retrospective chart review was performed on all patients who underwent office-based facial plastic surgery procedures from July 2008 to July Patient demographic data including age, gender, body mass index (BMI), past medical history, social history, surgical history, allergies, and medications were collected. Anesthesia-related data were also collected including: American Society of Anesthesia (ASA) class, type of procedure, medications administered, and major complications related to sedation were assessed. Results: There were 199 patients (23 males and 176 females) who underwent 283 facial aesthetic surgical procedures. Mean age was 49.8 years (range, 29 to 80 years). There were 195 patients in ASA class I and 4 patients were in ASA class II. Patients underwent 44 upper blepharoplasty procedures, 35 lower blepharoplasty procedures, 5 browlifts, 43 upper blepharoplasty-browpexy, 46 facelifts, 38 neck lifts/lower facelifts, 54 fat grafting, 3 tip rhinoplasties, and 15 minor revision cases. During the study period, there were no major complications and no sedation issues. Conclusions: Facial aesthetic surgical procedures can be performed safely and comfortably in the office-based setting under oral sedation in appropriately selected patients. Level of Evidence: 4 Accepted for publication May 30, 2015; online publish-ahead-of-print October 7, Therapeutic According to The American Society for Aesthetic Plastic Surgery, the number of cosmetic surgery procedures have steadily increased over the past several years. 1 As with other specialties, in an effort to provide expedient cost effective medical care, plastic surgeons have moved away from a traditional inpatient hospital setting to outpatient surgical facilities. 2,3 In 2013, the American Society of Plastic Surgeons reported that 71% of all cosmetic procedures were performed in an office-based setting under formal anesthesia. 4 The convenience and privacy of office-based surgery is appealing to patients and physicians alike. It affords greater control, more efficiency, as well as decreased cost for patients. Certainly, it has changed the way anesthesia is delivered with increased use of sedative techniques and local anesthesia, avoiding general anesthesia all together in some cases. 5-7 Accordingly, patient safety has come into question over the past decade, prompting several professional organizations to assemble task forces and provide guidelines for physicians providing office-based anesthesia Dr Butz is a Resident and Next Generation Editor of Aesthetic Surgery Journal and Dr Few is a Clinical Professor of Surgery, Section of Plastic and Reconstructive Surgery, University of Chicago Medicine, Chicago, Illinois; and Cosmetic Medicine Section Editor of Aesthetic Surgery Journal. Dr Gill is a plastic surgeon in private practice in Naples, Florida. Ms Randle and Ms Kampf are research assistants at a private plastic surgery practice in Chicago, Illinois. Corresponding Author: Dr Julius W. Few, 875 N. Michigan Avenue, Suite 3850, Chicago, IL 60611, USA. drj@fewinstitute.com

2 128 Aesthetic Surgery Journal 36(2) Certainly, in our practice, the demand for aesthetic facial surgery with the minimal downtime and quick recovery has increased. As such, we have adopted a novel local anesthetic approach in our patients using minimal oral sedation (anxiolysis). In this study we retrospectively review all aesthetic facial surgery performed by the senior author using anxiolytic oral sedation in an American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) accredited office-based surgery setting. To our knowledge, there are no published series using primary oral sedation with local anesthesia alone for comprehensive elective facial cosmetic surgery. METHODS A retrospective chart review of all consecutive patients undergoing aesthetic facial surgical procedures in an AAAASF certified office-based surgical suite from July 2008 to July 2014 was conducted in September This study was conducted in accordance with the Declaration of Helsinki. Demographic data including patient age, gender, body mass index (BMI), past medical history, social history, surgical history, allergies, and medications were collected. In addition, American Society of Anesthesia (ASA) class (Table 1), type of procedure, medications administered, and major complications related to sedation were assessed. Criteria for major complications included intra-operative need for intubation, emergent transfer to a hospital, deep venous thrombosis, pulmonary embolism, and death. All patients were interviewed prior to surgery to confirm their procedure, update medical history, obtain blood pressure before and after sedation, and pregnancy testing when indicated by age/history. No antibiotic prophylaxis was given unless indicated for other medical reasons. Operative times and local infusion volumes were recorded. In compliance with AAAASF guidelines, fat aspiration was less than 500 ml and all safety precautions were taken during and after the procedure. Table 1. American Society of Anesthesia (ASA) Classification ASA I Normal healthy patient without active disease Oral Sedation Protocol All patients were evaluated on the day of surgery by the senior author. A pretreatment checklist was reviewed prior to administration of any oral sedation. This checklist included confirming the planned procedure, obtaining informed consent, a thorough review of the patient s medical history, current medications, allergies, as well as baseline vital signs including blood pressure, heart rate, and oxygen saturation. All patients received minimal oral sedation utilizing a combination of diazepam, diphenhydramine, and hydrocodone/acetaminophen or acetaminophen alone. In patients with a hydrocodone or codeine allergy, tramadol was substituted as an analgesic. Dosage was determined with the senior author taking into account the patient s age, weight, baseline blood pressure, medication history, history of alcohol consumption, and type of procedure being performed. In general, patients greater than 60 years of age received 5 mg of oral diazepam and patients younger than 60 received 10 mg. 11 In addition, patients were given 25 to 50 mg of diphenhydramine and 5 to 10 mg of hydrocodone. All patients were given a minimum of 30 minutes to allow for onset of action prior to infiltration of local anesthesia. Once adequately sedated, local anesthesia was infiltrated to the surgical site. The senior author preferred to use 1% lidocaine with epinephrine (1: ) using a 27- gauge needle at all incision sites. In patients undergoing rhytidectomy or submental liposuction, a standard tumescent solution of 250 ml normal saline with 30 ml of 1% lidocaine with epinephrine (1: ) was infiltrated. For our rhytidectomy performed in the office, we typically performed a short scar rhytidectomy with superficial muscular aponeurotic system plication with or without an open neck. We did not perform upper and lower blepharoplasty in the same setting in the office. The upper blepharoplasty will include ptosis repair if appropriate. Lower blepharoplasty was typically approached transconjunctivally with a skin pinch. Volume of infiltration was procedure dependent. Level of consciousness was checked routinely throughout the surgery using response to verbal commands, as recommended by ASA Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists. 12 Post-procedure patients were discharged home with a caregiver. ASA II ASA III ASA IV ASAV ASAVI Patient with mild systemic disease (eg, hypertension under medical control) Patient with severe systemic disease Patient with severe systemic disease that is a constant threat to life Patient who is moribund and is not expected to survive without surgery Patient who has been declared brain-dead for organ donation RESULTS During the study period 199 patients (23 males and 176 females) underwent 283 facial aesthetic surgical procedures on 239 separate surgical days. Mean age was 49.8 years (range, 29 to 80 years). Average BMI was 22.7 kg/m 2 (range, kg/m 2 ). There were 195 patients in ASA class I and 4 were in ASA class II (Table 2). Patients underwent 44 upper blepharoplasty procedures, 35 lower blepharoplasty procedures, 5 browlifts, 43 upper blepharoplasty-browpexy,

3 Butz et al 129 Table 2. Demographic Data Table Total Males Females N Age (years) Range Mean Table 3. Procedures Performed, Revision Rate, and Average Length of Surgery No. of Procedures Average Operative Time (minutes) Revisions (%) Facial fat grafting (2%) Facelift (SMAS plication) Upper blepharoplasty (2%) (9%) BMI (kg/m 2 ) a Range Mean ASA Class I Upper blepharoplasty/ browpexy Necklift (anterior, posterior, submental, liposuction, neck band) (2%) (13%) Class II Class III Class IV Smoking 1 1 (4.5%) 0 Diabetes (2.2%) ASA, American Society of Anesthesia; BMI, body mass index. a BMI data was not available for 34 patients (4 males and 30 females). Lower blepharoplasty (9%) Revisions (5%) Browlift Tip rhinoplasty 3 NA 0 NA, not available. Total: 283 Average: facelifts, 38 neck lifts/lower facelifts, 54 fat grafting, 3 tip rhinoplasties, and 15 minor revision cases (Table 3). Average follow-up time was 23.5 months (range, 1 week to 83 months). During the study period there were no major complications and no sedation issues. All procedures were completed under oral sedation and there were no conversions to IV sedation, no cases were ended due to pain or discomfort and no patients required hospital transfer. There were no hematomas or infections encountered in this database. Revision rate was 15/283 (5.3%). Estimated blood loss for cases presented was less than 50 ml. All patients in the series tolerated their procedure. The average length of surgery was 84 minutes (range, 17 to 270 minutes). There were no incidences of postoperative nausea or vomiting. DISCUSSION Office-based procedures have become increasingly popular due to the improved privacy, efficiency, and decreased cost to patients. During the study period over 280 facial procedures were performed without any major complications. To our knowledge, this presentation represents the only case series to describe a range of facial aesthetic surgeries under oral sedation alone. This regimen provides the patient anxiolysis throughout the procedure and they do not require an intravenous line placement or sequential compression devices. We have found the use of oral antibiotics unnecessary, as the surgeries are elective head and neck procedures with low risk for infection. We feel that the lack of infection without antibiotic prophylaxis is important and may be indicative of overuse in other settings as well. The study results suggest that a wide range of facial plastic surgery procedures can be done safely with minimal oral sedation and local anesthetics without comprising the quality of the results. Patient safety is the most critical factor. Our facility is AAAASF accredited and as required, we have protocols for an emergency. Our surgical suite is fully stocked with advance life support drugs and an updated Banyan Emergency Medicine kit (Banyan International Corp., Palatine, IL) is onsite with a defibrillator and related emergency medicine materials. We have a written agreement for an emergency stretcher exit and admitting privileges to a hospital four blocks away. Sedation and analgesia comprise a continuum from anxiolysis or minimal sedation through general anesthesia. 12 Regardless of the level of sedation, successful sedation requires reduced pain associated with administration of local anesthesia, reduced patient anxiety toward surgery, and reduced patient recall of the procedure. 13 The oral route for

4 130 Aesthetic Surgery Journal 36(2) sedation administration is easy, convenient, painless, and inexpensive. Furthermore, patients generally have few objections to taking medications by mouth. Just as with other methods of sedation, oral sedation does not guarantee effective level of sedation, nor does it prevent a deeper level of sedation from being obtained. As such, Donaldson et al suggested utilizing the lowest effective dose to meet the goals of sedation. 14 Benzodiazapines were born out of the need for safer sedative/hypnotic medications, due to the narrow safety profile of barbiturates, which were the most utilized sleep aids in the early 20th century. Diazepam has been available for over 40 years and is considered the prototypical benzodiazepine. It has 100 % oral bioavailability, and given its lipophilic molecular profile, results in a fast onset of action between 20 to 40 minutes. Like all other benzodiazepines, Diazepam acts by potentiating the effects of major inhibitory neurotransmitter gamma-aminobutyric acid (GABA) to the GABA A subtype of GABA receptors in the brain. This multi-subunit receptor is closely related to gated chloride ion (Cl-) channels on the membrane of neurons. When GABA activates its receptors, these gated chloride channels open, allowing influx of Cl- ions and a more negative resting membrane potential, rendering less response of the neurons to excitatory stimuli. The safety profile of benzodiazepines is rooted in the fact that this drug class only potentiates the effects of GABA, and does not influence the gated Cl- independent of GABA. This is in contrast to barbiturates and propofol, which both open Cl- channels independent of GABA. Although very high doses of benzodiazepines can be fatal, the large margin between effective dose and lethal dose render it extremely unlikely the doses required for sedation would be close to a lethal dose. In addition, flumazenil, a competitive benzodiazepine receptor antagonist can be administered in cases of inadvertent overdose. Antihistamines, primarily used to manage allergic reactions, also cause sedation as a side effect. They are inverse agonists of the H1 histaminergic receptor, binding and stabilizing it in its inactive confirmation. The action of antihistamines on the CNS is dependent on the ability to cross the blood brain barrier, which further depends on the lipophilic quality of the molecule. First-generation antihistamines such as diphenhydramine are more lipophilic than their second-generation counterparts. Both safety and efficacy studies have been undertaken showing when in combination with benzodiazepines, first-generation as opposed to second- generation antihistamines act synergistically with benzodiazepines. 14 Diphenhydramine was originally approved by the FDA in Its onset of action is within 15 to 30 minutes of oral administration, with peak concentration occurring in about 2 to 4 hours. Careful patient selection is the critical first step in preventing devastating sedation-related complications. Patient with an ASA Class III or greater are not ideal candidates for office- based procedures and should be booked under the supervision of an anesthesiologist. Likewise, patients with OSA or history of difficult airway/anesthesia complications should also be cleared medically prior to considering the sedation protocol. Prior to the procedure the patients should also be screened to ensure they have not taken any additional medications or substances that could interact with the oral medications. Patients with poorly controlled blood pressure are not given the option for this protocol; there were only 4 patients that were ASA Class II. Any patient with hypertension undergoes a medical workup, blood pressure checks, and medical management as recommended by their primary care provider prior to surgery. Pre-procedure vitals are obtained and if the patient is hypertensive or tachycardic they are medicated and additional time is given to allow them to acclimate. If their vitals do not normalize, the procedure is postponed or rescheduled to be done under IV sedation with an anesthesiologist at a nearby surgery center or hospital. Patient safety is the number one priority, and we credit our low hematoma and surgical complication rate to following these criteria. Adherence to these pre-procedure protocols is likely one of the reasons we had no hematomas in our facelift group. The rate of hematomas in the literature ranges from 1.9% to 3.4%. 15 Not having a hematoma in 46 patients that are extremely low risk (ASA Class 1 or 2 and no history of hypertension) is within the margin of error. Patients should also be counseled on what to expect during the procedure to help mentally prepare them for the different sounds and feelings they might experience. Equally as important as patient selection, is selecting the appropriate medication and dosage. The office-based approach is based on the entire experience. Patients are never made to feel rushed or overly part of the preparation for surgery. Instruments are placed out of patient view, and there are a comfortable background of relaxing music and a decreased room lighting prior to surgery. Care is taken to titrate medication to presenting vital signs. For patients with an elevated heart rate or slightly elevated blood pressure on presentation, they are medicated and then reassessed. We have found the inclusion of diphenhydramine very powerful as it potentiates sedation while decreasing local edema with the surgical approach. We are careful to avoid large doses of narcotics as we find the liberal use of local anesthesia is the primary tool. Care is taken to record lidocaine administration and all cases are well under lidocaine toxicity levels. In the office-based oral sedation procedures the surgeon must be willing to discuss the procedure with the patient at appropriate times and reassure the patient throughout. This is a critical part of the approach and failure to do so may result in undesirable outcomes. Many office-based procedures are also being performed with IV anesthesia or Monitored Anesthesia Care under the

5 Butz et al 131 care of an anesthesiologist. 3,16 Although, this does provide some of the benefits of performing surgery in an office-based setting, such as, the privacy and convenience, it does come at a significantly increased cost. Surgery in the office setting, under general anesthesia, has been proven safe and effective but it can be associated with serious risk. 17 However, the oral regimen discussed provides adequate anesthesia and comfort for the patient in a safe and controlled manner. The retrospective design of this study is the main limitation. However, these patients had close follow-up and all were evaluated on postoperative day 1. Another limitation to the study design is lack of a control group. It is conceivable that the surgical time was prolonged in comparison to more traditional general anesthesia surgery but the outcome in this series appears favorable regardless. The 5% revision rate may seem high, but we prefer to err on the conservative side and perform a small touch up later on than have the patient appear done. This study addresses the feasibility and complications of facial aesthetic procedures performed under local anesthesia, but it does not address the quality of the results. However, we believe the results are equivalent, and we guarantee the same level of patient perceived satisfaction. Despite these limitations, the study demonstrates that facial aesthetic surgery can be safely performed under oral sedation in an office-based setting. To our knowledge, there are no published series using oral sedation with local anesthesia alone for comprehensive elective facial cosmetic surgery. CONCLUSION In healthy patients, office-based facial plastic procedures can be safely performed under a combination of oral sedation and local anesthetics. Patient selection and pretreatment counseling are critical in ensuring a satisfactory and safe experience. Disclosures The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. Funding The authors received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Cosmetic Surgery National Data Bank Statistics. Aesthet Surg J. 2015;35(Suppl 2): Byrd HS, Barton FE, Orenstein HH, et al. Safety and efficacy in an accredited outpatient plastic surgery facility: a review of 5316 consecutive cases. Plast Reconstr Surg. 2003;112(2): Bitar G, Mullis W, Jacobs W, et al. Safety and efficacy of office-based surgery with monitored anesthesia care/ sedation in 4778 consecutive plastic surgery procedures. Plast Reconstr Surg. 2003;111(1): Cosmetic Plastic Surgery Statistics. plasticsurgery.org/documents/news-resources/statistics/ 2013-statistics/cosmetic-procedures-national-trends pdf. Accessed March 7, Melloni C. Anesthesia and sedation outside the operating room: how to prevent risk and maintain good quality. Curr Opin Anaesthesiol. 2007;20(6): Perrott DH. Anesthesia outside the operating room in the office-based setting. Curr Opin Anaesthesiol. 2008;21 (4): Taub PJ, Bashey S, Hausman LM. Anesthesia for cosmetic surgery. Plast Reconstr Surg. 2010;125(1):1e-7e. 8. Parina R, Chang D, Saad AN, Coe T, Gosman AA. Quality and safety outcomes of ambulatory plastic surgery facilities in California. Plast Reconstr Surg. 2015;135(3): Iverson RE. ASPS Task Force on Patient Safety in Office- Based Surgery Facilities. Patient safety in office-based surgery facilities: I. Procedures in the office-based surgery setting. Plast Reconstr Surg. 2002;110(5): Rohrich RJ. Patient safety first in plastic surgery. Plast Reconstr Surg. 2004;114(1): Hämmerlein A, Derendorf H, Lowenthal DT. Pharmacokinetic and pharmacodynamic changes in the elderly. Clinical implications. Clin Pharmacokinet. 1998;35(1): American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2): Baker TJ, Gordon HL. Midazolam (Versed) in ambulatory surgery. Plast Reconstr Surg. 1988;82(2): Donaldson M, Gizzarelli G, Chanpong B. Oral sedation: a primer on anxiolysis for the adult patient. Anesth Prog. 2007;54(3): Moyer JS, Baker SR. Complications of rhytidectomy. Facial Plast Surg Clin North Am. 2005;13(3): Cinnella G, Meola S, Portincasa A, et al. Sedation analgesia during office-based plastic surgery procedures: comparison of two opioid regimens. Plast Reconstr Surg. 2007;119(7): Coldiron B, Shreve E, Balkrishnan R. Patient injuries from surgical procedures performed in medical offices: three years of Florida data. Dermatol Surg. 2004;30(12 Pt 1):