Moderate Conscious Sedation Research Articles

Optimal procedural sequence for same-day bidirectional endoscopy with moderate sedation: A prospective randomized study.

Same-day bidirectional endoscopy (BDE) is a commonly performed procedure, but the optimal sequence for the procedure with moderate conscious sedation is not well established. This study investigated the optimal sequence for same-day BDE under moderate conscious sedation and carbon dioxide insufflation in terms of sedation doses, patient discomfort, and colonoscopy performance. A prospective randomized controlled study of 120 patients who were scheduled for BDE examination was performed. Colonoscopy followed by esophagogastroduodenoscopy (EGD) examination was performed in 60 patients (colonoscopy-EGD group), and EGD followed by colonoscopy examination was performed in another 60 patients (EGD-colonoscopy group). Endoscopists and patients completed a questionnaire to assess objective and subjective discomfort. Baseline demographics, procedure indications, bowel preparation quality, cecal intubation rate/time, colonoscopy withdrawal time, endoscopic interventions, BDE procedure time, colon polyp/adenoma detection rates, patient discomfort, and adverse events were similar between the two study groups. The total doses of fentanyl and midazolam were significantly higher for the colonoscopy-EGD group than for the EGD-colonoscopy group (83.4±17.7 vs 68.7±18.6μg and 6.3±1.4 vs 5.2±1.3mg, P<0.0001 and P<0.0001, respectively). The recovery time to discharge was significantly longer for the colonoscopy-EGD group than for the EGD-colonoscopy group (43.5±16.2 vs 34.5±8.9min, P=0.0003). Esophagogastroduodenoscopy followed by colonoscopy is the optimal sequence for same-day BDE under moderate conscious sedation and carbon dioxide insufflation. Following this order allows for a reduction of sedation doses and for shorter recovery times.

Practice Guidelines for Intravenous Conscious Sedation in Dentistry (Second Edition, 2017).

Practice Guidelines for Intravenous Conscious Sedation in Dentistry (Second Edition, 2017).

Residual Gastric Volume After Bowel Preparation With Polyethylene Glycol for Elective Colonoscopy: A Prospective Observational Study.

To examine the residual gastric volume (RGV) in colonoscopy after bowel preparations with 3-L polyethylene glycol (PEG). Obstacles to high-volume bowel preparation by anesthesia providers resulting from concerns over aspiration risk are common during colonoscopy. Prospective measurements of RGV were performed in patients undergoing esophagogastroduodenoscopy (EGD) and morning colonoscopy with split-dose PEG preparation, patients undergoing EGD and afternoon colonoscopy with same-day PEG preparation, and patients undergoing EGD alone under moderate conscious sedation. Colonoscopy patients were allowed to ingest clear liquids until 2 hours before the procedure. Patients undergoing EGD alone were instructed to eat/drink nothing after midnight. There were 860 evaluated patients, including 330 in the split-dose preparation group, 100 in the same-day preparation group, and 430 in the EGD-only group. Baseline demographics and disease/medication factors were similar. The mean RGV in patients receiving the same-day preparation (35.4 mL or 0.56 mL/kg) was significantly higher than that in patients receiving the split-dose preparation (28.5 mL or 0.45 mL/kg) and in patients undergoing EGD alone (22.8 mL or 0.36 mL/kg) (P=0.023 and P<0.0001, respectively). Within the bowel-preparation groups, patients with fasting times of 2 to 3 hours had similar RGV compared with patients who had fasting times >3 hours. The shape of the distribution and the range of RGV among the 3 study groups were similar. No aspiration occurred in any group. PEG bowel preparations increase RGV mildly, but seem to have no clinical significance. These results support the current fasting guidelines for colonoscopy.

Starting Over With Moderate Sedation

For those who provide moderate (conscious) sedation, there are substantial changes coming. All CPT® instructions and codes change for dates of service on and after January 1, 2017. This article shows which codes will be deleted in 2017, and compares 2016 instructions and 2017 instructions for reporting moderate sedation.

Obstructive Sleep Apnea Is Not Associated with Higher Health Care Use after Colonoscopy under Conscious Sedation.

The use of sedation allows medical procedures to be performed outside the operating room while ensuring patient comfort and a controlled environment to increase the yield of the procedure. There is concern about a higher risk of adverse events with use of sedation in patients with obstructive sleep apnea. We aimed to determine if the presence of obstructive sleep apnea increased the risk of hospitalization and/or health care use after patients received moderate conscious sedation for an elective, ambulatory colonoscopy. We conducted a retrospective case-control database and chart review study. We compared hospital admissions, intensive care unit (ICU) admissions, and emergency room visits at 24 hours, 7 days, and 30 days in patients with obstructive sleep apnea (n = 3,860) and without obstructive sleep apnea (n = 2,374) who had undergone an elective, ambulatory colonoscopy with sedation. We found no significant differences in hospital admissions, ICU admissions, or emergency room visits between the two groups at any time point within the 30 days following the procedures. In a sensitivity analysis in which we compared 827 individuals with polysomnographically confirmed sleep apnea with control subjects, there was still no difference in hospital admissions, ICU admissions, or emergency room visits in the 30 days after receiving sedation for the procedure. Outcomes were not different in individuals with various severities of obstructive sleep apnea. The presence of obstructive sleep apnea was not associated with increased early hospital admissions, ICU admissions, or emergency room visits after colonoscopy with sedation.

Mo1424 Utilization of Deep Sedation for ERCP in Hospitalized Patients With Choledocholithiasis: Patterns of Care and Associated Outcomes

Patient and procedure-related factors influence the sedation type selected for endoscopy. ASGE guidelines consider use of deep sedation for long or complex procedures such as ERCP. To date, studies of moderate conscious versus deep sedation with propofol for ERCP have evaluated short-term outcomes such as patient tolerance of procedure, technical success, and recovery time, and most are limited to single centers with few patients. Our aim was to assess utilization of deep sedation with propofol among inpatients undergoing ERCP for choledocholithiasis and compare outcomes of mortality, complications, length of stay (LOS), and hospitalization cost between those who received deep sedation and those who did not.

Effectiveness of remifentanil & propofol infusion for procedural sedation in patients undergoing gastrointestinal endoscopic procedures: a systematic review protocol

Effectiveness of remifentanil & propofol infusion for procedural sedation in patients undergoing gastrointestinal endoscopic procedures: a systematic review protocol

Use of Ayer’s T piece circuit for monitored anaesthesia care for ERCP

Although moderate (conscious) sedation is intended during elective gastrointestinal endoscopy, unintended levels of deep sedation occur resulting in respiratory and cardiac compromise. We present here use of Ayre’s T-piece circuit along with nasopharyngeal airway for Endoscopic Retrograde CholangioPancreatography (ERCP) procedure under sedation which negates all the above problems, ensuring safety of the patient. DOI: http://dx.doi.org/10.4038/slja.v23i1.7043

Impact of Anesthesia on Mortality During Endovascular Clot Removal for Acute Ischemic Stroke

Endovascular clot retrieval is a technique available for removing intracranial arterial occlusions in acute ischemic stroke (AIS). This rescue therapy can be performed with moderate conscious sedation (CS) or general anesthesia (GA). The effect of GA on clinical outcome in AIS remains controversial. Therefore, we retrospectively investigated whether the use of CS or GA during endovascular intervention for AIS influenced outcomes. Patients who underwent emergent endovascular intervention for intracranial arterial occlusion during the years 2006 to 2012 were included in this study. Statistical analysis using the Spearman ρ was performed to examine demographic data and clinical outcomes between patients in the GA and CS groups. Binary logistic regression was used to determine the predictors of mortality. A total of 109 patients fit the inclusion criteria. Among them, 35 patients had GA and 74 patients had CS. Patients needing intubation upon admission for airway protection were more likely to receive GA (P<0.001). The duration of the procedure and the time-to-revascularization from symptom onset were significantly longer in the GA group. Mortality was higher in the GA group compared with the CS group (40% vs. 22%, P=0.045). Multivariate analysis, controlled for confounding variables, identified GA and elevated postprocedure glucose level to be significant predictors of mortality. Larger prospectively randomized multicenter trials evaluating the effects of GA and CS on clinical and radiographic outcomes seems warranted.

A prospective, randomized, double blinded comparison of intranasal dexmedetomodine vs intranasal ketamine in combination with intravenous midazolam for procedural sedation in school aged children undergoing MRI.

Background:For optimum magnetic resonance imaging (MRI) image quality and to ensure precise diagnosis, patients have to remain motionless. We studied the effects of intranasal dexmedetomidine and ketamine with intravenous midazolam for pre-procedural and procedural sedation in school aged children.Patients and Methods:Children were randomly allocated to one of two groups: (Group D) received intranasal dexmedetomidine 3 μg kg–1 and (Group K) received intranasal ketamine 7 mg kg–1. Sedation levels 10, 20 and 30 min after drug instillation were evaluated using a Modified Ramsay sedation scale. A 4-point score was used to evaluate patients when they were separated from their parents and their response to intravenous cannulation.Results:The two groups were comparable in terms of the child's anxiety at presentation (P = 0.245). We observed that Group K achieved faster sedation at 10 min point with P < 0.05. A comparable sedation score at 20 and 30 min were noted. The two groups were comparable regarding to the child's acceptance of nasal administration (P = 0.65). The sedation failure rate was insignificantly differ between groups (13.7% vs. 20.6% for Group D and K respectively). Heart rate and systolic blood pressure showed a significant difference between the two groups starting from the point of 20 min.Conclusion:Intranasal dexmedetomidine 3 μg kg–1 or ketamine 7 mg kg–1 can be used safely and effectively to induce a state of moderate conscious sedation and to facilitate parents’ separation and IV cannulation. Addition of midazolam in a dose not sufficient alone to produce the target sedation achieved our goal of deep level of sedation suitable for MRI procedure.

Office-based endovascular suite is safe for most procedures

This study was conducted to identify the safety of endovascular procedures in the office endovascular suite and to assess patient satisfaction in this setting. Between May 22, 2007, and December 31, 2012, 2822 patients underwent 6458 percutaneous procedures in an office-based endovascular suite. Demographics of the patients, complications, hospital transfers, and 30-day mortality were documented in a prospective manner. Follow-up calls were made, and a satisfaction survey was conducted. Almost all dialysis procedures were done under local anesthesia and peripheral arterial procedures under conscious sedation. All patients, except those undergoing catheter removals, received hydrocodone and acetaminophen (5/325 mg), diazepam (5-10 mg), and one dose of an oral antibiotic preprocedure and three doses postprocedure. Patients who required conscious sedation received fentanyl and midazolam. Conscious sedation was used almost exclusively in patients having an arterial procedure. Measurements of blood urea nitrogen, creatinine, international normalized ratio, and partial thromboplastin time were performed before peripheral arteriograms. All other patients had no preoperative laboratory tests. Patients considered high risk (American Society of Anesthesiologists Physical Status Classification 4), those who could not tolerate the procedure with mild to moderate conscious sedation, patients with a previous bad experience, or patients who weighed >400 pounds were not candidates for office based procedures. There were 54 total complications (0.8%): venous, 2.2%; aortogram without interventions, 1%; aortogram with interventions, 2.7%; fistulogram, 0.5%; catheters, 0.3%; and venous filter-related, 2%. Twenty-six patients required hospital transfer from the office. Ten patients needed an operative intervention because of a complication. No procedure-related deaths occurred. There were 18 deaths in a 30-day period. Of patients surveyed, 99% indicated that they would come back to the office for needed procedures. When appropriately screened, almost all peripheral interventions can be performed in the office with minimal complications. For dialysis patients, outpatient intervention has a very low complication rate and is the mainstay of treatment to keep the dialysis access patent. Venous insufficiency, when managed in the office setting, also has a low complication rate. Office-based procedural settings should be seriously considered for percutaneous interventions for arterial, venous, and dialysis-related procedures.

The Safety and Efficacy of Therapeutic ERCP in the Pediatric Population Performed by Adult Gastroenterologists

Endoscopic retrograde cholangiopancreatography (ERCP) is much less commonly performed in the pediatric population compared to adults. As a result, few pediatric gastroenterologists receive adequate training in ERCP. At many institutions, pediatric ERCP is performed by adult gastroenterologists not formally trained in pediatric gastroenterology. The purpose of this study was to assess the efficacy and safety of ERCP performed in pediatric patients by adult gastroenterologists in a single tertiary care center. We performed a retrospective analysis of pooled endoscopic procedures in pediatric patients (age<18 years) at the University of Maryland Medical Center, between 2003 and 2011, by two adult therapeutic endoscopists. Neither endoscopist had formal training in pediatric ERCP prior to 2003. Outcome measures included the procedure indications, cannulation success rates, procedure success rates, type of anesthesia, therapeutic interventions, frequency and type of procedure related complications, and technical complexity. Forty-five patients were included with a mean age of 12 years (range 6-17). There were a total of 70 ERCP procedures. Choledocholithiasis was the most common indication. Modes of anesthesia included monitored anesthesia care (31, 44.3%), general anesthesia (22, 31.4%) and moderate conscious sedation (17, 24.3%). The papilla cannulation success rate was 98.6% (69/70). Therapeutic maneuvers included 31 biliary sphincterotomies, ten pancreatic sphincterotomies, 17 pancreatic duct stents, 16 bile duct stents, two cystgastrostomy stents, four biliary stricture dilations, one minor papillotomy site dilation, one mechanical lithotripsy and one ampullectomy. The procedural success rate was 97.1% (68/70). The overall complication rate was 7.1% (5/70) with a post-ERCP pancreatitis rate of 4.3% (3/70). Complications included infection (moderate-1), bleeding (moderate-1), and post-ERCP pancreatitis (mild-1, moderate-2). ERCP procedures in pediatric patients can be safely and efficaciously performed by adult gastroenterologists trained in advanced endoscopy.

Sedation in gastrointestinal endoscopy: current issues.

Diagnostic and therapeutic endoscopy can successfully be performed by applying moderate (conscious) sedation. Moderate sedation, using midazolam and an opioid, is the standard method of sedation, although propofol is increasingly being used in many countries because the satisfaction of endoscopists with propofol sedation is greater compared with their satisfaction with conventional sedation. Moreover, the use of propofol is currently preferred for the endoscopic sedation of patients with advanced liver disease due to its short biologic half-life and, consequently, its low risk of inducing hepatic encephalopathy. In the future, propofol could become the preferred sedation agent, especially for routine colonoscopy. Midazolam is the benzodiazepine of choice because of its shorter duration of action and better pharmacokinetic profile compared with diazepam. Among opioids, pethidine and fentanyl are the most popular. A number of other substances have been tested in several clinical trials with promising results. Among them, newer opioids, such as remifentanil, enable a faster recovery. The controversy regarding the administration of sedation by an endoscopist or an experienced nurse, as well as the optimal staffing of endoscopy units, continues to be a matter of discussion. Safe sedation in special clinical circumstances, such as in the cases of obese, pregnant, and elderly individuals, as well as patients with chronic lung, renal or liver disease, requires modification of the dose of the drugs used for sedation. In the great majority of patients, sedation under the supervision of a properly trained endoscopist remains the standard practice worldwide. In this review, an overview of the current knowledge concerning sedation during digestive endoscopy will be provided based on the data in the current literature.

Office Based Endovascular Suite Is Safe for Most Procedures

This study assessed the safety of endovascular procedures in office setting over a long-term period. Between May 22, 2005, and November 22, 2011, 2309 patients underwent 5029 percutaneous procedures in an office-based procedural suite. Demographics of the patients, complications, and hospital transfers were documented in a prospective manner. Follow-up calls were made, and a satisfaction survey was administered. Most procedures were done under local anesthesia or conscious sedation. All patients, except those having catheter removal, received acetaminophen and hydrocodone (5/500), diazepam (5 to 10 mg), and one dose of an oral antibiotic preprocedure and three doses postprocedure. Patients requiring conscious sedation received fentanyl and midazolam. Conscious sedation was used in patients having peripheral arterial interventions. Blood urea nitrogen, creatinine, international normalized ratio, and partial thromboplastin time were performed prior to peripheral arteriograms. Patients on dialysis (end-stage renal disease) had no laboratory work done preoperatively. Patients considered high risk, those who could not tolerate the procedure with mild to moderate conscious sedation, or those who were morbidly obese were not candidates for office-based procedures. There were no procedure-related deaths. Procedures and complications are listed in the Table. There were 45 total complications (0.9%), of which 20 (0.4%) were site related, 14 (0.3%) were deep venous thrombosis after a venous procedure, and 11 (0.2%) were other medical problems. Seventeen procedures required subsequent hospital transfer. Of those patients surveyed, 99% indicated that they would come back to the office for needed procedures.TableOffice based procedural complications May 22, 2005–November 22, 2011ProcedureProcedures (No.)Complications, No.DVT (No.)Hospital transfers (No.)TotalSite-relatedMedicalArteriogram with runoff4226512Arteriogram with interventionaArteriogram interventions include angioplasty, coiling, stenting, atherectomy.3257615Fistulogram162111Fistulogram interventionbFistulogram interventions include angioplasty, coiling, stenting.13752111Fistulogram with thrombectomy of dialysis access4987346EVLT313826EVLT & micro427927Microphlebectomy110211Catheter insertion329221Catheter exchange229Catheter gram4Catheter removal628Powerport111Powerport removal15Venogram43Venoplasty5IVC filter insertion4111IVC filter removal29a Arteriogram interventions include angioplasty, coiling, stenting, atherectomy.b Fistulogram interventions include angioplasty, coiling, stenting. Open table in a new tab When appropriately screened, almost all peripheral interventions can be done in the office with minimal complications. For dialysis patients, outpatient intervention has a very low complication rate and is the mainstay of treatment to keep the dialysis access patent. Venous insufficiency when managed in the office setting also has a low complication rate. Office-based procedural settings should be the preferred site for percutaneous interventions for arterial, venous, and dialysis-related procedures.

Failed Colonoscopies Referred by Community Colonoscopists for Double-balloon Enteroscopy - Successful Completion by Water Exchange Colonoscopy

Purpose: To describe the use of water exchange method for the successful cecal intubation of patients referred for prior incomplete “difficult” colonoscopy performed by community gastroenterologists. Current guidelines recommend a cecal intubation rate >90% for all and 95% for screening cases. Incomplete cases occur in up to 10-17%. Single (GIE 2010;71:1319) and double (Endoscopy 2012;44:38) balloon-assisted examinations have been reported to salvage cecal intubation in these difficult cases. Water exchange method has been proposed as an inexpensive but effective technique for improving cecal intubation rates in difficult colonoscopies (Scand J Gastro 2011;46:517, JIG 2011;1:172). Methods: From Jan 2011 to Mar 2012, 10 patients with prior failed cecal intubation were referred to the UC Davis Medical Center GI Lab for double balloon enteroscopy by community physicians. Water exchange colonoscopy was performed on these patients by a single endoscopist. At the outset, the air pump was turned off. Water was infused through the colonoscope to expand the lumen. Residual air was suctioned as the scope was advanced through the colon. Water containing fecal debris was suctioned and replaced with clean water predominantly during insertion. When the cecum was reached, the air pump was turned on and lumen fully distended to allow for optimal visualization. Patient characteristics and procedural outcomes were reviewed and tabulated retrospectively. Results: (See Table) Ten patients (F/M: 7/3), age 60.3±14.7 yrs (range 37-82) were included. Indication for procedure was surveillance (4), screening (4) and diagnostic (2). Each patient underwent successful completed colonoscopy using the water exchange method. Cecal intubation time was 16.6±8.4 (range 6-28) min. Total procedure time was 28.4±8.5 (range 19- 43) min. Eight of the procedures were completed under conscious sedation (versed, fentanyl, Demerol, Benadryl, phenergan). Two patients had sedation given by anesthesiologist using moderate conscious sedation (versed, fentanyl). One patient was given remifentanyl. Average BMI was 26.4±5.5 (range 19.2-36.3). The polyp detection rate was 60%; adenoma detection rate was 50% in these patients. There were no complications.Table: Table. Reasons for prior failed cecal intubation based on referral documentsConclusion: The results provide proof-of-principle confirmation that water exchange method is effective for completing difficult colonoscopies. Patients with risk factors for difficult colonoscopy such as female sex, low and high BMI, prior abdominal surgery, young or advanced age, unsatisfactory bowel preparation, history of irritable bowel syndrome, or poor pain tolerance should be considered for this technique when undergoing colonoscopy.

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is increasingly used to sample mediastinal and hilar lymph nodes and has excellent diagnostic test characteristics. The determinants of sampling adequacy, however, have not been extensively examined. We set out to determine which procedural variables were associated with acquisition of tissue sufficient for pathologic analysis during EBUS-TBNA. A retrospective analysis of all EBUS-TBNA cases performed over 32 months by 10 proceduralists at our institution was completed. Variables potentially associated with sampling adequacy were analyzed. A total of 1304 procedures performed by 10 proceduralists while the patient received conscious sedation were included for analysis. Sampling adequacy was 94.2% overall and varied with the primary proceduralist (87% to 99.2%; P<0.001). Diagnostic yield per procedure for malignancy or a specific benign diagnosis was 43.2% overall. Proceduralists with a higher average number of lymph node stations sampled per procedure had improved sampling adequacy (parameter estimate=1.32; P=0.007). Sampling adequacy was lower with lymph nodes smaller than 10 mm (parameter estimate=-0.7; P=0.002) but was not associated with procedural environment (hospital procedural suite vs. clinic-based procedural suite) (P=0.08), lymph node station (P=0.69), propofol use (P=0.90), or average annual proceduralist cases performed (P=0.21). Only 6/216 (2.8%) patients had subsequent procedures (EBUS-TBNA or surgery) that indicated the initial EBUS-TBNA had inadequate sampling potentially leading to a missed cancer diagnosis. Excellent EBUS-TBNA sampling adequacy can be achieved by pulmonologists in a large group setting, who are not exclusively dedicated to interventional pulmonary medicine, using only moderate conscious sedation.

Colonoscopy core curriculum

Colonoscopy core curriculum

Safety and Efficacy of Single Balloon Enteroscopy: A 2 Year Veterans Affairs Medical Center Experience

Purpose: Single Balloon Enteroscopy (SBE) is a novel method of push and pull enteroscopy, allowing deep intubation of the small bowel (SB). Long-term outcomes data on utilization and efficacy of this technique have only recently emerged, but data on the utility of SBE in the Veteran's Affairs (VA) population are lacking. Here we evaluate the safety, efficacy and utility of SBE in the VA population. Methods: Forty-seven SBE studies in 39 consecutive patients from a single operator at the Sacramento VA Medical Center between December 2008 and April 2011 were retrospectively reviewed and data of outcome measures including depth of insertion, extent of examination, procedure time, complications, diagnostic yield and related therapeutic or diagnostic interventions were collected. All procedures were performed under moderate conscious sedation. Results: Of the 39 patients reviewed, 36 (92%) were men and 3 (8%) were women. The mean age was 66 +/- 10 years. Twenty-nine (74%) patients were Caucasian, 8 (21%) patients were African-American and 2 (5%) were not reported. Of the 47 studies, the major indications were occult obscure GI bleed (62%), overt obscure GI bleed (13%), abdominal pain (19%), unexplained weight loss (13%), chronic diarrhea (11%) and suspected tumor/mass (6%). Four (9%) studies used the retrograde approach while 43 (91%) used the anterograde approach. The mean ASA score was 2.06 +/- 0.04. Six (13%) cases were done in-patient and 41 (87%) as out-patient. The mean procedure time was 54.7 +/- 2.25 minutes. The mean extent of examination for the retrograde approach was 143.8 +/- 32.9 cm, while that for the anterograde approach was 273.7 +/- 10.3 cm. The overall diagnostic yield was 76.6%. Findings on SBE included angioectasias (44.7%), ulcers (10.6%), NSAID enteritis (8.5%0, erosions (6.4%), evidence of celiac disease (4.3%), tumors (4.3%) and stricture (2.1%). Thirty-three (70%) cases benefited from therapeutic intervention. Diagnostic intervention by mucosal biopsy was utilized in 19 (40%) cases. There were no complications. Conclusion: Small bowel enteroscopy is a safe and well tolerated procedure for the evaluation of SB pathology in VA patients. That complete enteroscopy was not achieved in any of our patients suggests that the greatest utility of SBE may be in further evaluation of previously localized disease. Further studies dedicated to evaluating the efficacy of SBE in this setting would further improve utilization of this technique.

Adverse events of conscious sedation in ambulatory spine procedures

Interventional spine procedures are commonly performed in the ambulatory surgical setting, often using conscious sedation. The rate of adverse events with conscious sedation has not been previously assessed in the interventional spine procedure setting. The goal of this study was to determine the rate of adverse events when using conscious sedation in the ambulatory interventional spine setting. A retrospective cohort chart review analysis was performed on all interventional spine procedures performed during one calendar year at a university-affiliated ambulatory surgery center by six nonanesthesia-trained spine interventionalists. Of the 3,342 procedures performed that year, 2,494 charts (74.6%) were available for review. Adverse events were documented immediately after the procedure and at a maximum 3-day follow-up phone call. The rate and type of adverse events were analyzed and compared between those who received conscious sedation with local anesthesia and those who received local anesthesia alone. Of the 2,494 cases reviewed, 1,228 spine procedures were performed with local anesthesia and conscious sedation, and 1,266 procedures were performed with local anesthesia alone. Of these cases, 66 immediate adverse events (5.12%) were documented in the conscious sedation group, and 61 immediate adverse events (4.82%) were documented in the local anesthesia alone group. At maximum 3-day follow-up, 670 patients of the conscious sedation group were available for contact, and 699 patients were available from the local anesthesia group. Thirty-two adverse events (4.77%) were noted in the conscious sedation group, and 28 adverse events (4.00%) were noted in the local anesthesia group. Comparison of these rates found no significant statistical difference. However, patients in the local anesthesia group had a significantly higher rate of postoperative hypertension. Adverse events reported both immediately and at follow-up were determined to be mild, with no serious adverse events reported. The findings of this study suggest that mild to moderate conscious sedation in interventional spine procedures is associated with low rates of adverse events when established protocols are followed.

Impact of Drug Label Changes on Propofol Use in Pediatrics for Moderate Conscious Sedation

Background Drug product labeling is a critical component of communication regarding the appropriate use of medications. The information contained in a drug label is often complex, including contraindications and warnings that may be difficult to understand. In an attempt to further examine this issue, this article looks at one such difficult-to-understand label concerning anesthetic propofol and its use in the pediatric population. Objective The objective of this study was to describe the use of propofol for moderate conscious sedation (MCS) in pediatric patients (0–17 years) after drug warnings were disseminated. Methods This study was a retrospective, observational study from January 2001 to December 2007 that used data from the Premier Perspective Comparative Hospital database. This database includes approximately 425 hospitals with a broad range of hospital types and contains a weighting scheme that allows for the generation of national estimates in the United States. The main outcome measure was use of propofol during hospitalization. Results The study included 307,779 discharges in which MCS was used. Both the number of discharges for MCS and the percent of discharges using propofol increased from 2001 to 2007. After multivariable adjustment, there was more than a 3-fold increase in the odds of receiving propofol between 2001 and 2007 (odds ratio [OR] = 3.32; 95% CI, 2.96–3.72) for MCS. Conclusions The results of this study suggest that the label changes and a “Dear Doctor” letter did not affect propofol utilization. A more cohesive approach to the assessment of safety and the dissemination of label change information to practitioners is needed.