Patient-controlled Sedation Group Research Articles

Sedation during endoscopic retrograde cholangiopancreatography: a randomized controlled study of patient-controlled propofol sedation and that given by a nurse anesthetist

Objective. Different regimens are used for sedation during endoscopic retrograde cholangiopancreatography (ERCP). Our objectives were to compare safety, ease of treatment, recovery, and patients’ experiences using patient-controlled sedation (PCS) with propofol, nurse anesthetist-controlled sedation (ACS), or the department’s standard of care, midazolam given by the procedure team (control group). Material and methods. The study included 281 adults in 301 procedures. The PCS group (n = 101) delivered bolus doses of 5 mg of propofol according to their need for sedation. The ACS group (n = 100) had 2–8 mg/kg/h of propofol infused, with the target for sedation being level 3 of the Observer’s Assessment of Alertness/Sedation (OAA/S) scale. The control group was given 2–3 mg of midazolam for induction and additional 1 mg if required. Results. PCS and ACS increased the ease of the procedure and reduced the number of sedation failures compared to midazolam sedation (ACS n = 0; PCS n = 4; midazolam n = 20). The ACS group had more deeply sedated patients (OAA/S level 2), desaturation, and obstructed airways than the PCS and midazolam groups. Time to full recovery (Aldrete score ≥9) was shortest following PCS. PCS resulted in the least fatigue and pain after the procedure. Patients’ preference for PCS and ACS was the same. Conclusion. PCS with propofol is superior to midazolam and comparable to ACS. PCS resulted in a rapid recovery, fewer respiratory events, and was almost as effective as ACS in ensuring a successful examination.

A Randomized Controlled Trial Comparing Patient-Controlled and Physician-Controlled Sedation in the Emergency Department

We compare patient-controlled sedation (PCS) and emergency physician-controlled sedation (EPCS) with respect to propofol requirements, depth of sedation, adverse events, recovery time, physician satisfaction, and patient satisfaction in emergency department (ED) patients requiring brief but painful procedures. One hundred sixty-six patients in this randomized controlled trial received propofol sedation according to one of 2 regimens: infusion of propofol at doses determined by the treating physician (EPCS group) or infusion of propofol with a patient-controlled infusion pump (PCS group). The PCS group received an initial physician-controlled bolus following by self-administered doses. Depth of sedation was assessed at 3-minute intervals. Adverse events were recorded as they occurred. Physician and patient satisfaction were recorded with 100-mm visual analog scales. There was a nonsignificant trend toward lower total propofol doses with PCS relative to EPCS (medians 1.36 versus 1.60 mg/kg, respectively; median difference -0.15 mg/kg; 95% confidence interval of the difference -0.33 to 0.05 mg/kg; P=.14). Adverse events, requirement for treatment of adverse events, and recovery time did not differ in the 2 groups. Depth of sedation was lower in the PCS group. Procedural success, ease of procedure, and patient satisfaction were similar in both groups despite nearly twice as many patients recalling the procedure in the PCS group and 15% of patients requiring additional physician-administered doses in the PCS group. Compared with EPCS, PCS demonstrated similar propofol dosing, safety, recovery, and satisfaction but resulted in lighter sedation. Propofol PCS appears safe and effective for ED procedures requiring moderate rather than deep sedation.

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.).

Patient-controlled sedation vs. anaesthetic nurse-controlled sedation for cataract surgery in elderly patients

Patient-controlled sedation (PCS) with propofol has been used successfully in various conditions, but controversies exist about its use in sedation of elderly patients for cataract surgery. This study evaluates the efficacy of anaesthetic nurse-controlled sedation (ACS) compared with PCS using the same device and the drug. All of the 153 elderly patients (aged 51-88 years) undergoing cataract surgery with a sub-Tenon's infiltration were assigned to receive ACS (n = 51) or PCS (n = 51) with propofol or no intra-operative sedation (control, n = 51). Propofol was administered with a bolus dose of 10 mg and a lockout interval of 1 min. Cognitive function, sedation, pain, anxiety, side effects and satisfaction of patients were evaluated. The mean +/- SD doses of propofol administered were 34.9 +/- 8.8 mg and 30.1 +/- 30.4 mg in the groups ACS and PCS, respectively. The anxiety score was lower in both ACS and PCS groups compared with control group but was not different between the two groups. Patient's satisfaction was highest in PCS group, ACS group was the next, compared with non-sedated group. Other parameters were not different among the three groups. Both ACS and PCS using propofol provided reduced anxiety compared with control, but patient's satisfaction was higher in the PCS group compared with ACS group.

Effect‐site targeted patient‐controlled sedation with propofol: comparison with anaesthetist administration for colonoscopy

Patient-controlled sedation (PCS) allows patients to match their sedation requirement to perceived discomfort. The significant delay in onset of sedation may be overcome with effect-site steered target controlled infusion, but previously only trials in volunteers have been carried out. We therefore conducted a randomised, double-blind controlled trial comparing effect-site steered propofol PCS with anaesthetist-administered propofol sedation in 40 patients presenting for colonoscopy. The initial effect-site target in the PCS group was 0.8 microg.ml(-1), increment was 0.1 microg.ml(-1) and lockout was 3 min. Patient and endoscopist satisfaction and operating conditions were similar between the two groups. PCS patients were sedated more slowly (13 [7.1] vs. 3 [1.1] min; p < 0.0001) and less deeply (minimum BIS value: 71 [16] vs. 58 [15]; p = 0.13) than anaesthetist-administered propofol sedation patients. More of the latter patients were hypotensive, but all patients had similar recollection of events during the procedure and similar quality of recovery.

Significance of patient-controlled sedation during colonoscopy: Results from a prospective randomized controlled study

In France, general anesthesia is given to more than 90% of patients undergoing colonoscopy although in several countries sedation is limited to intolerant patients. This study was carried out to determine whether Patient-Controlled Sedation (PCS) could provide a lighter sedation than general anesthesia adapted to the patient's individual requirement. Patients aged from 18 to 80 scheduled for elective colonoscopy were prospectively randomized to receive either standard sedation (control group) or patient-controlled-sedation (PCS). In the control group, patients received a continuous infusion of propofol. Patients in the PCS group were connected to an infusion pump containing propofol and self-administered 20-mg boluses as often as they required. An anesthetist was present throughout the procedure. Patient satisfaction measured on a visual analog scale four hours after colonoscopy was the main outcome criterion. From December 2002 to September 2003, 402 patients underwent elective colonoscopy, 173 of them were eligible and were asked to participate in the study. Seventy-two gave their informed consent and were prospectively randomized. The patients' mean satisfaction scores were not statistically different between the two groups: 84.7 mm (PCS group) vs. 91.5 mm (control group); P = 0.24. Mean doses of propofol (60 mg vs. 248 mg; P <0.001), depth of sedation and time before discharge (1.75 hours vs. 4.45 hours) were significantly lower for patients in the PCS group; nine of them (25.7%) did not use the pump and had total colonoscopy without sedation. There were no statistically significant differences between the two groups regarding total duration of colonoscopy (19.4 min (PCS) vs. 18 min (control)) difficulty and therapeutic procedures (biopsy or polypectomy). Two weeks after the procedure, 96.5% of patients in the PCS group were willing to repeat the examination under the same conditions vs. 72.5% of patients in the control group (P = 0.03). Our results demonstrate that need of sedation is widely overestimated in France. A subset of our patients is willing to consider colonoscopy without general anesthesia. For them, PCS with propofol is an effective and very well accepted form of sedation.

Patient-controlled sedation versus intravenous sedation for colonoscopy in elderly patients: A prospective randomized controlled trial

Background: A prospective randomized trial was conducted to compare the safety, effectiveness, and patient acceptance of patient-controlled sedation and intravenous sedation for colonoscopy in a group of elderly patients undergoing outpatient colonoscopy. Methods: One hundred patients over 65 years of age were recruited and randomized to patient-controlled sedation (n = 50) or intravenous sedation (n = 50) groups by means of computer-generated numbers. In the patient-controlled sedation group, a mixture of propofol and alfentanil was delivered by means of a patient-controlled pump; each bolus delivered 4.8 mg propofol and 12 μg alfentanil. No loading dose was used and the lockout time was set at zero. In the intravenous sedation group, fixed doses of diazemuls (0.1 mg/kg) and meperidine (0.5 mg/kg) were given with further increases in dosages administered at the discretion of the endoscopist. Outcome measures assessed included cardiopulmonary complications, recovery time, pain score, and satisfaction score. Results: The mean (SD) age of patients in the patient-controlled sedation and intravenous sedation groups were, respectively, 72.4 years (5.3) and 73.5 years (6.1). The mean dose of propofol consumed in the patient-controlled sedation group was 0.79 (0.46) mg/kg. The mean doses of diazemuls and meperidine consumed in intravenous sedation group were, respectively, 5.8 (1.3) mg and 30.1 (6.8) mg. Hypotension occurred in 2 (4%) patients in the patient-controlled sedation group and 14 (28%) in the intravenous sedation group ( p < 0.01). Oxygen desaturation was recorded for 4 patients (8%) in the intravenous sedation group. The median (interquartile range [IQR]) recovery time was significantly shorter in the patient-controlled sedation group compared with the intravenous sedation group (respectively, 0 minutes [IQR 0-5] vs. 5 minutes [IQR 5-10]; p < 0.01). There were no statistically significant differences between groups for pain and satisfaction scores. Conclusions: Patient-controlled sedation appears to be safer than intravenous sedation, with comparable effectiveness and acceptance, in elderly patients undergoing elective outpatient colonoscopy. (Gastrointest Endosc 2002;56:629-32.)

Patient-controlled sedation with propofol for colonoscopy

Background: Patient-controlled sedation (PCS) allows the patient to titrate the dosage of sedative drugs according to need. Methods: To compare the efficacy of PCS by using propofol with anesthetist-administered midazolam during colonoscopy, 88 patients were randomized to receive either intravenous midazolam 0.05 mg/kg bolus (1 mg increments as required) or propofol PCS (0.3 mg/kg bolus, zero lockout). Heart and respiratory rates, blood pressure, and oxygen saturation were monitored. Patient cooperation, endoscopist satisfaction, and level of sedation were scored. Patient satisfaction was assessed by questionnaire. To correct for multiple testing of data, statistical significance was asserted only for individually stated p values with p < 0.01. Results: Oxygen saturation and hemodynamics were stable in both groups. Better patient cooperation (good vs. minimal; p = 0.008) and higher endoscopist satisfaction (very good vs. good; p = 0.001) were achieved with PCS. Although more sedated intraoperatively (sedation score 4 vs. 2; p = 0.03 for a single test of hypothesis; correction for multiple testing of data removes this significance), patients in the propofol PCS group were more alert by 30 minutes and discharged earlier (mean and SD times were 43.3 [12.1] min compared with 61.0 [29.7] min; p = 0.001.) More patients in the PCS group (86 vs. 6l%; p < 0.001) were satisfied with their overall level of comfort. Conclusion: PCS with propofol is effective and results in high patient satisfaction and faster discharge. (Gastrointest Endosc 2001;54:8-13.)

Effect of Patient-controlled Sedation on Recovery from Ambulatory Monitored Anesthesia Care

Patient-controlled sedation (PCS) with propofol has been shown to be an effective means of conscious sedation during monitored anesthesia care. The purpose of this study was to assess both the intraoperative conduct and postoperative recovery of patients receiving propofol for conscious sedation, randomized to either PCS or anesthetist-controlled sedation (ACS). Forty-three patients scheduled for outpatient procedures requiring monitored anesthesia care were randomized to PCS or ACS. Both groups received an initial bolus of propofol 0.5 mg/kg and fentanyl 1 microgram/kg i.v., followed by an identical background infusion of propofol 50 micrograms/kg per minute. Subsequent doses of propofol 30 mg i.v. were either self-administered (PCS) or administered at the discretion of the anesthetist (ACS). Variables measuring hemodynamics, ventilation, saturation, and level of sedation were measured at baseline, after initial bolus of propofol and fentanyl, after skin incision, at last stitch, at admission to recovery, and 1 hour later. More propofol was used by the PCS group (P < 0.05). Finger-tapping was slower and responsiveness scores were lower in the PCS group at the end of the procedure (P < 0.05). More patients in the PCS group required oxygen supplementation (saturation < 90%) on admission to recovery (P < 0.05). At 1 hour after recovery admission, however, there were no differences between groups. These results indicate that when patients determine their own sedation, they are more sedated at the end of a procedure than when the anesthetist determines the level of sedation.