Sedation For Colonoscopy Research Articles

Randomized controlled trial of patient‐controlled sedation for colonoscopy: Entonox vs modified patient‐maintained target‐controlled propofol

Propofol sedation is often associated with deep sedation and decreased manoeuvrability. Patient-maintained sedation has been used in such patients with minimal side-effects. We aimed to compare novel modified patient-maintained target-controlled infusion (TCI) of propofol with patient-controlled Entonox inhalation for colonoscopy in terms of analgesic efficacy (primary outcome), depth of sedation, manoeuvrability and patient and endoscopist satisfaction (secondary outcomes). One hundred patients undergoing elective colonoscopy were randomized to receive either TCI propofol or Entonox. Patients in the propofol group were administered propofol initially to achieve a target concentration of 1.2 μg/ml and then allowed to self-administer a bolus of propofol (200 μg/kg/ml) using a patient-controlled analgesia pump with a handset. Entonox group patients inhaled the gas through a mouthpiece until caecum was reached and then as required. Sedation was initially given by an anaesthetist to achieve a score of 4 (Modified Observer's Assessment of Alertness and Sedation Scale), and colonoscopy was then started. Patients completed an anxiety score (Hospital Anxiety and Depression questionnaire), a baseline letter cancellation test and a pain score on a 100-mm visual analogue scale before and after the procedure. All patients completed a satisfaction survey at discharge and 24 h postprocedure. The median dose of propofol was 174 mg, and the median number of propofol boluses was four. There was no difference between the two groups in terms of pain recorded (95% confidence interval of the difference -0.809, 5.02) and patient/endoscopist satisfaction. There was no difference between the two groups in either depth of sedation or manoeuvrability. Both Entonox and the modified TCI propofol provide equally effective sedation and pain relief, simultaneously allowing patients to be easily manoeuvred during the procedures.

Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study

The SEDASYS System is an investigational computer-assisted personalized sedation system integrating propofol delivery with patient monitoring to enable endoscopist/nurse teams to safely administer propofol. To compare the safety and effectiveness of the SEDASYS System to the current standard of care for sedation during routine endoscopic procedures. Nonblinded multicenter randomized comparative study. Four ambulatory surgery centers, 3 endoscopy centers, and 1 academic center in the United States. One thousand American Society of Anesthesiologists physical status class I to III adults undergoing routine colonoscopy or EGD. Sedation with the SEDASYS System (SED) and sedation with each site's current standard of care (CSC; benzodiazepine/opioid combination). Area under the curve of oxygen desaturation was the primary endpoint. Secondary endpoints included patient satisfaction, clinician satisfaction, level of sedation, and patient recovery time. Four hundred ninety-six patients were randomized to SED and 504 to CSC. Area under the curve of oxygen desaturation was significantly lower for SED (23.6 s·%) than for CSC (88.0 s·%; P = .028). Patients were predominately minimally to moderately sedated in both groups. SED patients were significantly more satisfied than CSC patients (P = .007). Clinician satisfaction was greater with SED than with CSC (P < .001). SED patients recovered faster than CSC patients (P < .001). The incidence of adverse events was 5.8% in the SED group and 8.7% in the CSC group. Nonblinded. The SEDASYS System could provide endoscopist/nurse teams a safe and effective on-label means to administer propofol to effect minimal to moderate sedation during routine colonoscopy and EGD.

A Proof-of-Concept RCT to Confirm the Beneficial Effects of the Water Method on U.S. Veterans Undergoing Colonoscopy with the Option of On-demand Sedation

Purpose: Whether the water method can facilitate completion of unsedated colonoscopy in patients who received sedation for prior colonoscopy is unknown. Sedation for colonoscopy imposes recovery time burden on patients (median 47 minutes onsite and 17.7 hours at home) (AJG 2007;102:2401). The objective of this abstract is to report the impact of the water method and on demand sedation on completion of unsedated colonoscopy and patient recovery time burden. Methods: Veterans accepting on demand sedation for screening or surveillance colonoscopy were randomized to air or water method for colonoscope insertion. Main outcome measurements: Completion of colonoscopy without sedation, onsite and at home recovery times. Results: 100 patients were randomized, 50/group. 27 in the air and 39 in the water group completed colonoscopy without requiring sedation (p<0.05, Fisher's exact test). Thirteen of the 100 patients had prior sedated colonoscopy requiring Midazolam 1-5 mg, Fentanyl 25-100 μg and Benadryl 50 mg. Ten of the 13 patients completed colonoscopy without sedation (3 in the air and 7 in the water group). The water method reduced onsite and at home recovery times (Tables 1). Table 2 lists the actual and hypothetical times saved. Limitations: Single VA site, predominantly male veterans, unblinded examiners.[1478] Table 1. Patient recovery time on site and at home[1478] Table 2. Actual and hypothetical patient recovery times savedConclusion: When veterans accepted the option of on demand sedation, the water method facilitated completion of unsedated colonoscopy, including those with a prior history of sedated colonoscopy, and reduced total patient onsite and at home recovery time burden.

Patient Satisfaction Comparison of Conscious Sedation vs. Propofol in Open-Access Community Endoscopy Suite Setting

Purpose: There is a growing trend to utilize propofol for all outpatient endoscopic procedures leading to increased costs for surveillance endoscopy. Our study evaluates usefulness of selected criteria to limit use of propofol in the open-access community endoscopy setting. Methods: In an open-access endoscopy setting, a set criterion was given to scheduling team for assigning patients to undergo endoscopy via propofol (P). All patients with history of regular use of narcotics or benzodiazepines, history of documented anxiety disorder, as well as patients reporting difficulty with prior sedation were assigned to receive propofol. All other patients were administered conscious sedation (CS). Over a set six month period, we performed a prospective study of 3163 consecutive patients undergoing routine endoscopy in our suite. An attempt was made via telephone to contact all patients with a 46.5% response rate to selected questionnaire. A score of 1 to 5 (highest) was awarded for sedation level, comfort level, and overall experience. We also evaluated rates of post-procedure nausea for patients receiving either CS or P. Results: For routine colonoscopy, the overall experience score for the CS group was 4.85 vs. 4.91 for the P group (T=1.61, P=0.11). For routine endoscopy, the overall experience score for the CS group was 4.87 vs. 4.93 for the P group (T=1.35, P=0.18). Also see attached table. Patients receiving CS did report higher rates of post-procedure nausea (6.55%, N=1129) vs. the P group (2.05%, N=342). Patients receiving P did have statistically significant scores for sedation and comfort for colonoscopy, but not for EGD when compared to the CS group. However, there was no difference in overall experience scores for colonoscopy or EGD. Conclusion: There was no significant difference in overall patient satisfaction when comparing conscious sedation (CS) vs. propofol (P). Although propofol has a valuable role in providing comfort especially for a certain population of patients, limiting its use even in the open-access endoscopy setting can result in comparable patient satisfaction, while reducing health care costs.Table: [1371] Patient satisfaction scores comparing CS vs. propofol

Nitrous oxide sedation for colonoscopy—no laughing matter

Moderate sedation is typically used during lower gastrointestinal endoscopy procedures. Deep sedation with propofol is becoming widespread but carries the risk of cardiorespiratory depression. Nitrous oxide is an inhaled sedative administered routinely in dentistry that might prove to be a safe option for sedation during lower gastrointestinal endoscopy.

Sedation Issues in Quality Colonoscopy

The subject of endoscopic sedation for colonoscopy remains controversial because of unresolved questions concerning the relative benefits, risks, and cost of service. There is also disagreement about the most appropriate sedation drug(s), delegation of responsibility for drug administration, and patient monitoring. This article examines recent trends in endoscopic sedation; the impact of sedation on the quality, safety, and patient tolerability of colonoscopy; and reviews the economic implications of current sedation practices.

Patient satisfaction with on-demand sedation for outpatient colonoscopy

To reduce the costs of colonoscopy the feasibility of unsedated procedures has been explored. The aims of our study were to assess patient satisfaction with on-demand sedation and identify factors related to painful colonoscopy. The Norwegian Gastronet quality assurance documentation tools consist of endoscopy reports (completed on site) and a patient satisfaction questionnaire (completed by the patient on the day after colonoscopy). Data were collected from January 1 2004 to December 31 2006. Colonoscopies reported to be moderately or severely painful were defined as "painful colonoscopy." Nine endoscopy centers representing 86 endoscopists reported 14 915 examinations and 12 354 patient reports were returned (83 % response rate). Patient satisfaction with service and information given was greater than 95 % for all centers. Mean rate of painful colonoscopy was 34 % and mean sedation rate 34 %. Odds ratio (OR) for painful colonoscopy was 2.2 ( P < 0.001) when sedation was given. The ORs for painful colonoscopy were similar for all but one center (no. 4) with OR 1.6 ( P = 0.04), while the OR for giving sedation was higher for all but one center (no. 1) compared with the reference center (ORs 2.2 to 7.5, all P-values < 0.001). A surprisingly high rate of painful colonoscopy was found. High sedation rates were not associated with low rates of painful colonoscopy. Recommending increased sedation rates as the only intervention to improve suboptimal performance might not lead to lower rates of painful colonoscopy.

Projected increased growth rate of anesthesia professional–delivered sedation for colonoscopy and EGD in the United States: 2009 to 2015

Anesthesia professional-delivered sedation has become increasingly common when performing colonoscopy and EGD. To provide an estimate of anesthesia professional-participation rates in colonoscopy and EGD procedures and to examine rate changes over time and geographic variations for both procedures. Retrospective sample design. National survey data from i3 Innovus for the period 2003 to 2007 on the use rate of anesthesia professionals in both procedures. A sample of 3688 observations included 3-digit zip code-level information on anesthesia professional use rates. Data were linked to the Bureau of Health Professions' Area Resource File to control for sociodemographic factors and provider supply characteristics for anesthesia professional use rates. Multivariable regression analyses were performed to identify factors predicting the use rate of anesthesia professionals in these procedures and to forecast use rates for the years 2009 to 2015. For colonoscopy and EGD, anesthesia professional participation is projected to grow from 23.9% and 24.4% in 2007 to 53.4% and 52.9% by 2015, respectively. Average growth rates were highest in the northeast for colonoscopy (145.8%) and EGD (146.6%). Anesthesia professional use rates were significantly greater in areas having a higher percentage of older subjects (45 years and older), higher per capita income and lower unemployment rates, and higher per capita inpatient admissions and were significantly lower in areas having more per capita outpatient visits for both procedures. Nonexperimental retrospective sample study design. Database sample may not be nationally representative. Market area characteristics were used to control for socioeconomic and demographic factors. However, there may remain some important market factors that we were unable to control. Anesthesia professional-delivered sedation is projected to grow substantially for both procedures.

Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation

Water immersion is an alternative colonoscopy technique that may reduce discomfort and facilitate insertion of the instrument. This was a prospective study to compare the success of colonoscopy with minimal sedation using water immersion and conventional air insufflation. A total of 229 patients were randomized to either water immersion or the standard air insertion technique. The primary outcome was success of minimal sedation colonoscopy, which was defined as reaching the cecum without additional sedation, exchange of the adult colonoscope or hands-on assistance for trainees. Patient comfort and satisfaction were also assessed. Successful minimal-sedation colonoscopy was achieved in 51 % of the water immersion group compared with 28 % in the standard air group (OR, 2.66; 95 % CI 1.48 - 4.79; P = 0.0004). Attending physicians had 79 % success with water immersion compared with 47 % with air insufflation (OR, 4.19; 95 % CI 1.5 - 12.17; P = 0.002), whereas trainees had 34 % success with water compared with 16 % using air (OR, 2.75; 95 % CI 1.15 - 6.86; P = 0.01). Using the water method, endoscopists intubated the cecum faster and this was particularly notable for trainees (13.0 +/- 7.5 minutes with water vs. 20.5 +/- 13.9 minutes with air; P = 0.0001). Total procedure time was significantly shorter with water for both experienced and trainee endoscopists ( P < 0.05). Patients reported less intraprocedural pain with water compared with air (4.1 +/- 2.7 vs. 5.3 +/- 2.7; P = 0.001), with a similar level of satisfaction. There was no difference in the neoplasm detection rates between the groups. Colonoscopy insertion using water immersion increases the success rate of minimal sedation colonoscopy. Use of the technique leads to a decrease in discomfort, time to reach the cecum, and the amount of sedative and analgesic used, without compromising patient satisfaction.

Comparison of intermittant bolus versus target-controlled infusion of propofol sedation for colonoscopy

Comparison of intermittant bolus versus target-controlled infusion of propofol sedation for colonoscopy

A prospective, randomized, comparative trial evaluating respiratory depression during patient-controlled versus anesthesiologist-administered propofol-remifentanil sedation for elective colonoscopy

Patient-controlled sedation (PCS) with propofol-remifentanil (PR) is associated with rapid sedation and recovery, but it is associated with a greater requirement for airway rescue than PCS with midazolam-fentanyl. To demonstrate that respiratory depression associated with PR is more frequent during anesthesiologist-administered sedation (AAS) than during PCS. Prospective, randomized, open-label study. Academic medical center. Fifty patients undergoing elective colonoscopy. PCS or AAS using PR. All patients breathed 100% oxygen via an anesthesia mask with continuous spirometry and bispectral index (BIS). Respiratory rate and BIS. Colonoscopy was completed in all patients. No patient under PCS required airway rescue. Five patients under AAS required bag-mask ventilation to resolve Sao(2) (arterial oxygen saturation) less than 90% lasting longer than 30 seconds. The median BIS for the AAS group was 71.7 (range 61.06-82.34) and 88.1 (range 83.15-93.05) for the PCS group. Median respiratory rates were 5.97 (range 1.21-10.73) breaths per minute for AAS and 13.19 (range 9.54-16.84) for PCS. Respiratory rates less than 2 breaths per minute composed 28% of the procedure time for AAS, but only 5% for PCS. Patients under PCS had lower median predicted effect site concentrations for PR, but were able to achieve brief peak levels exceeding those with AAS. These differences were significant (P < .001). Potential for bias with AAS. Patients undergoing colonoscopy with PR are significantly more likely to require intervention for hypoventilation compared with PCS. ( NCT00868920.).

Low-lying Fruit or the Wrong Tree?

Crouse Hospital, Syracuse, New York. jgerson@twcny.rr.comI was intrigued by the use of the metaphor “Anesthesia's Low-Lying Fruit” by Orkin and Duncan1in their Editorial View entitled “Substrate for Healthcare Reform: Anesthesia's Low-Lying Fruit.” I believe that it refers to the absence of data showing a major benefit conferred by anesthesiologists providing sedation for colonoscopy compared with other personnel using older drugs. The study for which the editorial was written, Alharbi et al. ,2did not attempt to look for any benefits (or harms) from anesthesiologist involvement in colonoscopy. That study looked strictly at the demographics of the providers of sedation for outpatient colonoscopy. The absence of documented benefits presumably provides the low-lying fruit for healthcare benefit czars to pluck. Orkin and Duncan state that “Anesthesiologist involvement in colonoscopy sedation in the absence of medical indication... may be one vignette among myriad throughout United States health care in which low-benefit services and procedures result in disproportionate expenditures.”One place to start looking for benefits (or harms), rather than making assumptions from untested hypotheses, might be to ask the patients. Could a randomized controlled trial that compared midazolam and narcotic administered by registered nurses to the addition of propofol to that drug regimen by an anesthesiologist be performed? If such a trial included patient satisfaction as an outcome benefit, I will wager it would be higher with propofol. As would gastroenterologist and nursing personnel satisfaction because of increased throughput in the facility and less struggling with patients insufficiently sedated during the procedure who then sleep for hours afterward. I think only those who pay for anesthesiologists' services might be less satisfied.To carry Orkin and Duncan's metaphor along further, to save money, why not instead prune anesthesia services from cataract surgery performed with topical anesthesia? That procedure seems to me to be less stressful than teeth cleaning by a dental hygienist. Cataract-induced discomfort is far under that of a colonoscopy. Or, as one patient told me: “I've had more painful haircuts than that cataract operation.”Crouse Hospital, Syracuse, New York. jgerson@twcny.rr.com

Sedation for flexible sigmoidoscopy and colonoscopy: is this a time for change?

Sedation for flexible sigmoidoscopy and colonoscopy: is this a time for change?

S1399: A Phase IB Study of the Safety and Efficacy of Multiple Doses of CNS 7056 in Volunteers Undergoing Colonoscopy, Including Reversal With Flumazenil

Fast onset/rapid clearance endoscopic sedation (FORCES) is increasingly popular. Propofol is typically administered by anesthesiologists due to a narrow therapeutic index and a lack of reversal agents. A novel benzodiazepine, CNS 7056, is metabolized by tissue esterases (not cytochrome P450) with a faster onset, a shorter duration, and more rapid recovery profile than other available drugs. We performed the first study of CNS 7056 as sedation for colonoscopy.

T1517: Sedation for Colonoscopy in Canada

T1517: Sedation for Colonoscopy in Canada

PTU-026 Patient experience of CT colonography within the Bowel Cancer Screening Programme

<h3>Introduction</h3> Patients with a positive faecal occult blood test in the BCSP are invited to undergo an alternative radiological colonic investigation if deemed unsuitable for colonoscopy. CTC, a radiological modality of choice at St Mark9s, is less invasive than optical colonoscopy but there are conflicting data regarding relative patient experience. Approximately two thirds of patients having colonoscopy in our centre are sedated with a combination of midazolam and pethidine compared to CTC, which is an unsedated procedure. The aim of this study was to compare patient experience of those undergoing CTC vs colonoscopy within the BCSP. <h3>Methods</h3> We retrospectively reviewed our local screening centre9s database from September 2008 to November 2009 to determine the number of patients who had undergone CTC within the BCSP and had also completed and returned a standard 30-day questionnaire (routinely sent to all patients following their secondary examination within the BCSP). The questionnaire includes four domains assessing experience before, during and after the procedure and also overall level of satisfaction. Completed questionnaires were then compared to an equal number of age and sex matched consecutive patients who had undergone optical colonoscopy during the same time period. Fisher9s exact test was used to compare responses. <h3>Results</h3> 21 (10 male, mean age 67 years, SD 4.7) of 83 patients undergoing CTC completed and returned a questionnaire (response rate of 25%), which is significantly lower than colonoscopy response rate of 72% (756 of 1057 patients) (p&lt;0.0001) for the similar time period. There was no significant difference between patient groups with respect to pre-procedure experience or overall satisfaction. However, CTC patients reported more discomfort than expected (8/21 vs 0/21, p=0.003) and only 4/21 (20%) had no or less discomfort than expected compared to colonoscopy (13/21, 62%, p=0.003). CTC patients were also more often discharged without knowing the result of the procedure (10/21 vs 2/21, p&lt;0.001) and were less likely contacted by screening practioners afterwards (13/21, 68% vs 20/21, 95%, p=0.04). <h3>Conclusion</h3> Discomfort during CTC is higher than patients expected and post examination communication is inferior, also reflected by lower questionnaire response rates. While colonoscopy sedation and use of a questionnaire designed for colonoscopy may be confounders, the authors conclude that centres should re-examine the quantity and quality of patient information provided for CTC by screening practitioners. We also recommend a larger prospective multicentre study to compare experience, using a more detailed and less “technique specific” questionnaire.

Fospropofol Disodium for Procedural Sedation: Emerging Evidence of its Value?

Background Fospropofol is a phosphate-ester water soluble prodrug of propofol approved in the United States for the short-term sedation of adults undergoing diagnostic or therapeutic procedures with monitored anesthesia care. Fospropofol may be advantageous for procedural sedation because it is not a lipid formulation, it lacks pain on injection, it possesses a different pharmacokinetic profile due to in vivo conversion of fospropofol to propofol, and it offers rapid recovery from sedation. Objective To review published pharmacokinetic data, clinical trials, and the safety profile of fospropofol and provide comment on its use for sedation. Clinical trials Fospropofol has been studied for sedation in colonoscopy and bronchoscopy with fentanyl for analgesia. Results indicate that a 6.5 mg/kg bolus dose with repeated doses of 25% of the original bolus dose up to every 4 minutes produces an effective and safe level of sedation. Fospropofol comparisons to midazolam were not assessed. Patient satisfaction is high for those treated with the recommended dosage regimen. Most commonly reported adverse effects included pruritus and paresthesia. Sedation related side effects such as hypoxia and apnea were rarely reported and generally mild in scope. Conclusion Fospropofol represents an alternative sedative agent to midazolam and propofol for short-term sedation. However, the efficacy and safety of fospropofol compared to midazolam or propofol has not been assessed, therefore use will be based on practitioner preference. Restrictive package labelling requiring MAC poses medico-legal and cost-benefit issues thereby not conferring a benefit over propofol which caries similar labelling. Additional studies designed to compare fospropofol to propofol and/or midazolam for procedural sedation are needed.

Sedation-risk-free colonoscopy for minimizing the burden of colorectal cancer screening.

Unsedated colonoscopy is available worldwide, but is not a routine option in the United States (US). We conducted a literature review supplemented by our experience and expert commentaries to provide data to support the use of unsedated colonoscopy for colorectal cancer screening. Medline data from 1966 to 2009 were searched to identify relevant articles on the subject. Data were summarized and co-authors provided critiques as well as accounts of unsedated colonoscopy for screening and surveillance. Diagnostic colonoscopy was initially developed as an unsedated procedure. Procedure-related discomfort led to wide adoption of sedation in the US, although unsedated colonoscopy remains the usual practice elsewhere. The increased use of colonoscopy for colorectal cancer screening in healthy, asymptomatic individuals suggests a reassessment of the burden of sedation in colonoscopy for screening is appropriate in the US for lowering costs and minimizing complications for patients. A water method developed to minimize discomfort has shown promise to enhance outcomes of unsedated colonoscopy. The use of scheduled, unsedated colonoscopy in the US appears to be feasible for colorectal cancer screening. Studies to assess its applicability in diverse practice settings deserve to be conducted and supported.

The Success Rate of Unsedated Colonoscopy Examination in Adult

Aim: . Aim of the study was to evaluate the feasibility of unsedated colonoscopy examination in the increasing trend of deep sedation colonoscopy examination in our countryMaterial & Methods: The endoscopy reporting system images of single-handed (one-man) method unsedated colonoscopy examinations were evaluated. Patients with history of colorectal surgery were excluded from the analysis.. We evaluated the success rate of caecal intubation by unsedated colonoscopy. Non parametric binomial test was applied for statistical analysis with p <0.05Results : There were 244 patients included in the study with 143 (82.66%) patients caecal intubated seccessfully(success group) and 30 (17.34%) patients failed to reach the caecum due to severe abdominal pain only(failure group) (p<0.0001). The lesions that obstructed the colonoscopy examination were 38 distal colon cancers, 9 proximal colon cancers, and 4 colon strictures. Eight patients with unfinished colonoscopy examination due to haemodynamic worsening, and 12 patients with unfinished colonoscopy examination due to bad bowel preparation (fecal obstruction). The success rate of endoscopic diagnosis confirmation was 86.61%(194) vs 13.39%(30) (p<0.0001). No complication or mortality was found in this study.Conclusion : the unsedated colonoscopy is still significantly feasible procedure for colon examination.

Hypoxemia Risk Factors During Sedation in ASA I/II Populations for Midazolam- and Propofol-Mediated Sedation for Routine EGD and Colonoscopy

Purpose: Hypoxemia is the most common cardiopulmonary event during endoscopic sedation. The risk factors for hypoxemia in a healthy ASA I/II patients have not been extensively studied in a large population. Methods: A post hoc analysis from a multicenter randomized controlled trial of subjects undergoing routine colonoscopy or EGD was performed. 1000 ASA I/II/III subjects with a BMI < 35 were randomized to receive either midazolam or propofol-mediated sedation by an endoscopist/nurse team. 494 ASA I/II subjects (357 colon, 137 EGD) received midazolam-mediated sedation. 478 subjects ASA I/II (347 colon, 131 EGD) received propofol-mediated sedation using the SEDASYS® System, an investigational device. Both groups also received a narcotic (fentanyl for propofol-mediated; fentanyl or meperidine for midazolam-mediated). The sedation target for both groups was minimal to moderate sedation. Pulse oximetry, capnography, BP and ECG data points were captured for both groups every second using a computerized digital storage device. Hypoxemia was defined as an O2 saturation <90% for >15 seconds. Potential risk factors analyzed were age ≥ 55 years, gender, BMI ≥ 30, BMI ≤ 20, and a history of cardiovascular or neurological/psychiatric disorders. The factors were analyzed using a multivariate ANOVA. Results: The number of subjects with hypoxemic events was significantly higher (p < 0.001) in the midazolam-mediated arm (76 subjects, 170 events) than in the propofol-mediated arm (32 subjects, 42 events). The risk factors for hypoxemia for the midazolam-mediated group that had statistical significance were subjects with a BMI ≥ 30 or a previous history of cardiovascular disease (Table 1). The propofol-mediated group showed no statistically significant risk factors (p > 0.15 for all factors), though the most influential risk factors mirrored those of the midazolam group, BMI ≥ 30 or a previous history of cardiovascular disease. Also of note, for the midazolam group gender as a risk factor (p=0.067) almost had statistical significance. There were 49% (243/494) females in the midazolam group. In the midazolam group 61% (46/76) of the subjects who experienced hypoxemia were female (49%). For the subjects who experienced hypoxemia the gender breakdown for the midazolam group showed a bias for hypoxemia for females.Table 1: Hypoxemia risk factors for Midazolam and propofol groupsConclusion: Even healthy subjects as defined by ASA I/II are prone to hypoxemia during endoscopic sedation. Propofol-mediated sedation using the SEDASYS System resulted in a significantly lower incidence of hypoxemia and appeared to mitigate the risk factors associated with midazolam-mediated sedation. Disclosure: John J. Vargo, MD, MPH, FACG, Consultant,Ethicon Endo-Surgery, Cininnati, OH Daniel J. Pambianco, MD, FACG Consultant,Ethicon Endo-Surgery, Cininnati, OH Paul Niklewski, BS Employee, Ethicon Endo-Surgery, Cininnati, OH.