Background: Patient-controlled sedation (PCS) is a documented method for endoscopic procedures considered to facilitate early recovery. Limited data have been reported, however, on its use during flexible bronchoscopy (FB).

Materials and Methods: This study hypothesized that PCS with propofol during FB would facilitate early recovery, with similar bronchoscopist and patient satisfaction compared with nurse-controlled sedation (NCS) with midazolam. A total of 150 patients were randomized 1:1:1 into a control group (premedication with morphine-scopolamine and NCS with midazolam), PCS-MS group (premedication with morphine-scopolamine and PCS with propofol), and PCS-G group (premedication with glycopyrronium and PCS with propofol).

Results: The procedures included transbronchial biopsy, transbronchial needle aspiration, cryotherapy/biopsy, and/or multistation endobronchial ultrasound. FB duration values in median (range) were 40 (10 to 80), 39 (12 to 68), and 44 (10 to 82) minutes for the groups NCS, PCS-MS, and PCS-G, respectively. An overall 81% of the patients in the combined PCS groups were ready for discharge (modified Post Anaesthetic Discharge Scoring System, score 10) 2 hours after bronchoscopy compared with 40% in the control group (P<0.0001). Between PCS groups, 96% of the PCS-G group patients were ready for discharge compared with 65% in the PCS-MS group (P=0.0002) at 2 hours. Bronchoscopists’ and patients’ satisfaction scores were high in all groups. Postdischarge quality scores showed no differences among the groups.

Conclusion: PCS with propofol during FB is feasible, as it shortened recovery time without compromising procedure conditions for bronchoscopists or patients. A rapid postsedation stabilization of vital signs facilitates surveillance before the patient leaves the hospital.

Background

Patient‐controlled sedation (PCS) with propofol accompanied by a bedside nurse anaesthetist is an alternative sedation method for endoscopic procedures compared with midazolam administered by a nurse or endoscopist. Increasing costs in health care demands an economic perspective when introducing alternative methods. We applied a hospital perspective on a cost analysis comparing different methods of sedation and the resource use that were expected to affect cost differences related to the sedation.

Methods

Based on two randomised previous studies, the direct costs were determined for different sedation methods during two advanced endoscopic procedures: endoscopic retrograde cholangiopancreatography (ERCP) and flexible bronchoscopy including endobronchial ultrasound. ERCP comparisons were made between midazolam sedation by the endoscopic team, PCS with a bedside nurse anaesthetist and propofol sedation administered by a nurse anaesthetist. Bronchoscopy comparisons were made between midazolam sedation by the endoscopic team and PCS with a bedside nurse anaesthetist, categorised by premedication morphine‐scopolamine or glycopyrronium.

Results

Propofol PCS with a bedside nurse anaesthetist resulted in lower costs per patient for sedation for both ERCP (233 USD) and bronchoscopy (premedication morphine‐scopolamine 267 USD, premedication glycopyrronium 269 USD) compared with midazolam (ERCP 425 USD, bronchoscopy 337 USD). Aborted procedures that needed to be repeated and prolonged hospital stays significantly increased the cost for the midazolam groups.

Conclusion

Propofol PCS with a bedside nurse anaesthetist reduces the direct sedation costs for ERCP and bronchoscopy procedures compared with midazolam sedation.

Background

Worldwide, ketamine is used during paediatric procedures, but no recommendations are available regarding a suitable dose for rectal administration during procedures involving high levels of pain and/or anxiety such as burn wound dressing change.

Methods

We evaluated three different single doses of rectally administered racemic ketamine mixed with a fixed dose of 0.5 mg/kg of midazolam. In total, 90 children – aged 6 months to 4 years – were randomised 1:1:1 to receive 4 mg/kg (K-4 group), 6 mg/kg (K-6 group) or 8 mg/kg (K-8 group) of racemic ketamine for a maximum of three consecutive procedures. Primary outcome measure was procedural pain evaluated by Face, Legs, Activity, Cry, Consolability (FLACC) behavioural scale. Secondary outcome included feasibility and recovery time. Patient safety was evaluated using surrogate outcomes.

Results

In total, 201 procedures in 90 children aged 19 ± 8 months were completed. The median maximum pain was FLACC 0 in all groups (p = 0.141). The feasibility was better for groups K-6 (p = 0.049) and K-8 (p = 0.027) compared with K-4, and the mean recovery time was the longest for group K-8 (36 ± 22 min) compared with groups K-4 (25 ± 15 min; p = 0.003) and K-6 (27 ± 20 min; p = 0.025). Median maximum sedation measured by the University of Michigan Sedation Scale (UMSS) was higher in group K-8 compared with group K-4 (p < 0.0001) and K-6 (p = 0.023). One child in group K-8 had a study drug-related serious adverse event — laryngospasm/airway obstruction. No rescue analgosedative medication was administered for group K-6.

Conclusions

A rectally administered mixture of racemic ketamine (6 mg/kg) and midazolam (0.5 mg/kg) during paediatric burn dressing procedures with a duration of approximately 30 min provides optimal conditions regarding pain relief, feasibility, recovery time and patient safety, with no need for rescue analgosedative medication.

Objective: Different regimens are used for sedation during ERCP (endoscopic retrograde cholangiopancreatography). Our objectives were to compare safety, ease of treatment, time to recovery and patients’ experiences using PCS (patient-controlled sedation) with propofol as well as sedation given by a nurse anaesthetist (ACS) with propofol or midazolam during ERCP.

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/hour of propofol infused, with the target for sedation being Level 3 of the Observer’s Assessment of Alertness/Sedation scale (OAA/S). 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 numbers 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), desaturations and obstructed airways than the PCS and midazolam groups. Over 90% of all patients had recovered (Aldrete score≥9) by the time they returned to the ward. PCS resulted in the least fatigue and pain after the procedure. Patients’ preference for PCS and ACS were the same.

Conclusion: PCS with propofol is superior to midazolam and comparable to ACS. PCS resulted in a rapid recovery, tended to be the safest and was almost as effective as ACS in ensuring a successful examination.

Background: Patient-controlled sedation (PCS) is increasingly used for moderate sedation. Detailed understanding is essential for maintaining safety and giving the most benefit. We wanted to explore the associations between patients’ characteristics, perioperative pain and anxiety, the procedure, and the calculated concentrations at the effect site (Ce) of propofol. We also wanted to analyse the pharmacokinetic profiles of propofol and alfentanil during PCS, and their association with respiratory complications.

Methods: 155 patients were double-blinded and randomised to have propofol or propofol and alfentanil for PCS during gynaecological surgery. Pharmacokinetic simulation of Ce and multiple regressions aided the search for correlations between explanatory variables and concentrations of drugs.

Results: In group propofol, treatment for incontinence, anterior repair, and the patient’s weight correlated the best (B-coef = 0.20, 0.20 and 0.01; r = 0.69; r² = 0.48). When alfentanil was added, alfentanil and the patient’s weight were associated with Ce of propofol (B-coef = -0.40 and 0.01; r = 0.70; r² = 0.43). Logistic regression indicated that age and Ce of drugs were related to ten cases of respiratory complications.

Conclusions: Patients’ weights and the type of surgery performed were associated with the Ce of propofol; this knowledge could be used for refinement of the doses given during PCS. Because the pharmacokinetic profiles of propofol and alfentanil are different, the alfentanil effect becomes predominant during the time course of sedation. In order to reduce the risk of early and late respiratory depression, alfentanil should not be added to propofol in the same syringe.

The need for procedural sedation is extensive and on the increase in numbers of patients. Minor treatments or diagnostic procedures are being performed with inadequate sedation or even without any sedatives or analgesics. Also, sedation techniques that support advanced, high-quality, in-patient care procedures representing easy performance and rapid recovery are requested for increased effectiveness. In this doctoral thesis, patient-controlled sedation (PCS) using propofol and alfentanil for surgical and diagnostic procedures was studied. The overall aim was to study aspects of safety, procedural feasibility and patients’ experiences. The main hypothesis was that PCS using only propofol is a safe and effective method for the induction and maintenance of moderate procedural sedation. The studies included were prospective, interventional, and in some cases, randomized and double-blinded.

Data on cardiopulmonary changes, level of conscious sedation (bispectral index and Observer’s assessment of alertness/sedation [OAA/S]), pain, discomfort, anxiety, nausea (visual analogue scales), interventions performed by nurse anaesthetists, surgeons’ evaluation of feasibility, procedure characteristics, recovery (Aldrete score) and pharmacokinetic simulation of concentrations of drugs at the effect site supported the analysis and comparison between PCS and anaesthetist-controlled sedation and propofol PCS with or without alfentanil.

PCS can be adjusted to cover a broad range of areas where sedation is needed, which, in this thesis, included burn care, gynaecological out-patient surgery and endoscopic procedures for the diagnosis and treatment of diseases in the bile ducts (endoscopic retrograde cholangiopancreatography [ERCP]). PCS for burn wound treatment demands the addition of alfentanil, but still seems to be safe. PCS was preferred by the patients instead of anaesthetist-controlled sedation. The addition of alfentanil to PCS as an adjunct to gynaecological surgical procedures also using local anaesthesia increases the surgeon’s access to the patients, but impairs safety. Apnoea and other such conditions requiring interventions to restore respiratory function were seen in patients receiving both alfentanil and propofol for PCS. Patients’ experiencing perioperative pain and anxiety did not explain the effect-site concentrations of drugs. Different gynaecological procedures and patients’ weights seemed to best explain the concentrations. For discomfort and pain during the endoscopic procedure (ERCP), propofol PCS performs almost the same as anaesthetist-performed sedation. Overall, as part of the pre-operative procedures, PCS does not seem to be time-consuming. In respect to the perioperative perspective, PCS supports rapid recovery with a low incidence of tiredness, pain, and post-operative nausea and vomiting (PONV).

The data suggest that PCS further needs to be adapted to the patient, the specific procedure and the circumstances of sedation for optimal benefit and enhanced safety.

Background

Widespread use of patient-controlled sedation (PCS) demands simplicity and a predictable outcome. We evaluated patients’ safety and ease of use of PCS for gynaecological outpatient procedures.

Methods

In a prospective double-blind study, 165 patients were randomized to use propofol or propofol with alfentanil as PCS combined with local anaesthetic for pain control. Data on cardiopulmonary function, consciousness, and need for interventions were collected at baseline and every fifth minute. The surgeons’ evaluation of the ease and the duration of the procedure were recorded.

Results

One hundred and fifty-five patients used PCS for the entire procedure, 76 patients propofol, and 79 patients propofol/alfentanil. Fifteen procedures in the propofol group were limited or could not be done, compared with four in the propofol/alfentanil group (P = 0.02). The duration of surgery was not affected. The addition of alfentanil affected respiratory function compared with the propofol group: five patients compared with none were manually ventilated (P = 0.03), and two thirds, compared with a quarter, were given supplementary oxygen as their saturation decreased below 90% (P < 0.001). Overall cardiovascular stability was maintained. The propofol group had deeper conscious sedation as measured by the bispectral index (P  = 0.03), but all patients could be roused. In the propofol/alfentanil group, five patients became apnoeic and could not be roused.

Conclusions

PCS using propofol alone supports patients’ safety, as the addition of alfentanil increased the need for specific interventions to maintain respiratory stability. However, alfentanil increases the feasibility of the procedure, as complementary doses of propofol were not required.

Background: The aim was to evaluate safety aspects of patient-controlled sedation and analgesia (PCS) for extracor-poreal shockwave lithotripsy (ESWL) and PCS to be handled by non-anaesthesiology doctors. Methods: Thirty-four ASA I-III patients used PCS with propofol and alfentanil for ESWL in this interventional study. Strict safety limits were defined regarding respiratory rate (RR), heart rate (HR), mean arterial blood pressure (MAP), oxygen saturation from pulse oximetry (SpO2), and transcutaneous partial pressures of oxygen (PtcO2) and carbon dioxide (PtcCO2). The pa-tients’ levels of consciousness was graded on a five-point scale and monitored with Bispectral Index (BIS). A nurse anaesthetist was supervising the procedure but was instructed to intervene only if safety limits were breached. No sup-plementary oxygen was given. Results: All patients responded to verbal stimuli during treatment. Cardiovascular sta-bility was maintained, but respiratory variables were affected. Two patients with SpO2 < 90% and two cases of RR ≤ 8 were diagnosed, and seven patients became hypercarbic (PtcCO2 ≥ 6.5 kPa). In 18 patients hypoxaemia was indicated as PtcO2 ≤ 8.0 kPa. All these 18 patients were given supplementary oxygen. There was no correlation between dose of drugs, age, weight or any vital variable. The 34 patients would use PCS again in the case of future treatment. Conclu-sions: During ESWL treatment PCS can be used with good patients’ satisfaction, and maintained cardiovascular stabil-ity, but PCS had an indisputable effect on pulmonary function with hypoxemia (resulting in need for supplementary oxygen) or hypercarbia. The person in charge of PCS must therefore be trained to perform according to the guidelines for sedation and/or analgesia by non-anaesthesiology doctors.

The aim of this study was to evaluate pain relief for patients with burns during rest and mobilization with morphine according to a standard protocol for patient-controlled analgesia (PCA). Eighteen patients with a mean (SD) burned TBSA% of 26 (20) were studied for 10 days. Using a numeric rating scale (NRS, 0 = no pain and 10 = unbearable pain), patients were asked to estimate their acceptable and worst experienced pain by specifying a number on a scale and at what point they would like additional analgesics. Patients were allowed free access to morphine with a PCA pump device. Bolus doses were set according to age, (100 - age)/24 = bolus dose (mg), and 6 minutes lockout time. Degrees of pain, morphine requirements, doses delivered and demanded, oral intake of food, and antiemetics given were used as endpoints. Acceptable pain (mean [SD]) was estimated to be 3.8 (1.3) on the NRS, and additional treatment was considered necessary at scores of 4.3 (1.6) or more. NRS at rest was 2.7 (2.2) and during mobilization 4.7 (2.6). Required mean morphine per day was 81 (15) mg, and the number of doses requested increased during the first 6 days after the burn. The authors found no correlation between dose of morphine required and any other variables. Background pain can be controlled adequately with a standard PCA protocol. During mobilization, the pain experienced was too intense, despite having the already high doses of morphine increased. The present protocol must be refined further to provide analgesia adequate to cover mobilization as well.

n/a