Topical pharyngeal anesthesia with articaine for gastroscopy: a double-blinded, randomized cross-over study in healthy volunteers.

OBJECTIVES: The benefits of topical pharyngeal anesthesia for gastroscopy remain under debate. Articaine, a local anesthetic with fast onset and offset of action as well as low systemic toxicity, could be a promising choice for topical anesthesia. The objective of this study was to assess whether topical pharyngeal anesthesia with articaine is beneficial in sedated gastroscopy. MATERIALS AND METHODS: This randomized double-blinded cross-over study included nine volunteers who underwent two gastroscopies under conscious sedation. One was performed with topical pharyngeal anesthesia with articaine and the other with placebo. Hemodynamic parameters including autonomic nervous system state were recorded prior to and during the endoscopic procedure. The endoscopist and the volunteer assessed the endoscopy after the examination. RESULTS: Topical pharyngeal anesthesia with articaine resulted in less discomfort during esophageal intubation and higher patient satisfaction with the procedure. Topical pharyngeal anesthesia with articaine did not increase satisfaction or facilitate the procedure as rated by the endoscopist. There were no clinically relevant differences in hemodynamic parameters. CONCLUSION: The use of articaine for topical pharyngeal anesthesia results in less intubation-related discomfort and better satisfaction.

Effect of 4% Albumin Solution vs Ringer Acetate on Major Adverse Events in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Randomized Clinical Trial.

Importance: In cardiac surgery, albumin solution may maintain hemodynamics better than crystalloids and reduce the decrease in platelet count and excessive fluid balance, but randomized trials are needed to compare the effectiveness of these approaches in reducing surgical complications. Objective: To assess whether 4% albumin solution compared with Ringer acetate as cardiopulmonary bypass prime and perioperative intravenous volume replacement solution reduces the incidence of major perioperative and postoperative complications in patients undergoing cardiac surgery. Design, Setting, and Participants: A randomized, double-blind, single-center clinical trial in a tertiary university hospital during 2017-2020 with 90-day follow-up postoperatively involving patients undergoing on-pump coronary artery bypass grafting; aortic, mitral, or tricuspid valve surgery; ascending aorta surgery without hypothermic circulatory arrest; and/or the maze procedure were randomly assigned to 2 study groups (last follow-up was April 13, 2020). Interventions: The patients received in a 1:1 ratio either 4% albumin solution (n = 693) or Ringer acetate solution (n = 693) as cardiopulmonary bypass priming and intravenous volume replacement intraoperatively and up to 24 hours postoperatively. Main Outcomes and Measures: The primary outcome was the number of patients with at least 1 major adverse event: death, myocardial injury, acute heart failure, resternotomy, stroke, arrhythmia, bleeding, infection, or acute kidney injury. Results: Among 1407 patients randomized, 1386 (99%; mean age, 65.4 [SD, 9.9] years; 1091 men [79%]; 295 women [21%]) completed the trial. Patients received a median of 2150 mL (IQR, 1598-2700 mL) of study fluid in the albumin group and 3298 mL (IQR, 2669-3500 mL) in the Ringer group. The number of patients with at least 1 major adverse event was 257 of 693 patients (37.1%) in the albumin group and 234 of 693 patients (33.8%) in the Ringer group (relative risk albumin/Ringer, 1.10; 95% CI, 0.95-1.27; P = .20), an absolute difference of 3.3 percentage points (95% CI, -1.7 to 8.4). The most common serious adverse events were pulmonary embolus (11 [1.6%] in the albumin group vs 8 [1.2%] in the Ringer group), postpericardiotomy syndrome (9 [1.3%] in both groups), and pleural effusion with intensive care unit or hospital readmission (7 [1.0%] in the albumin group vs 9 [1.3%] in the Ringer group). Conclusions and Relevance: Among patients undergoing cardiac surgery with cardiopulmonary bypass, treatment with 4% albumin solution for priming and perioperative intravenous volume replacement solution compared with Ringer acetate did not significantly reduce the risk of major adverse events over the following 90 days. These findings do not support the use of 4% albumin solution in this setting. Trial Registration: ClinicalTrials.gov Identifier: NCT02560519.

Doxapram as an additive to propofol sedation for endoscopic retrograde cholangiopancreatography: a placebo-controlled, randomized, double-blinded study.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) requires moderate to deep sedation, usually with propofol. Adverse effects of propofol sedation are relatively common, such as respiratory and cardiovascular depression. This study was conducted to determine if doxapram, a respiratory stimulant, could be used to reduce the incidence of respiratory depression. METHODS: This is a single-center, prospective randomized double-blind study performed in the endoscopy unit of Helsinki University Central Hospital. 56 patients were randomized in a 1:1 ratio to either receive doxapram as an initial 1 mg/kg bolus and an infusion of 1 mg/kg/h (group DOX) or placebo (group P) during propofol sedation for ERCP. Main outcome measures were apneic episodes and hypoxemia (SpO2 < 90%). Mann-Whitney test for continuous variables and Fisher's exact test for discrete variables were used and mixed effects modeling to take into account repeated measurements on the same subject and comparing both changes within a group as a function of time and between the groups. RESULTS: There were no statistically significant differences in apneic episodes (p = 0.18) or hypoxemia (p = 0.53) between the groups. There was a statistically significant rise in etCO2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p = 0.002) but not modified Observer's Assessment of Agitation/Sedation (p = 0.21) in group P. There were no statistically significant differences in any other measured parameters. CONCLUSIONS: Doxapram was not effective in reducing respiratory depression caused by deep propofol sedation during ERCP. Further studies are warranted using different sedation protocols and dosing regimens. Clinical trial registration ClinicalTrials.gov ID NCT02171910.

Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study.

BACKGROUND: Deep sedation with propofol and an opioid is commonly used for ERCP but is associated with increased risk and may require the presence of an anesthesiologist. Delivery of propofol and a short-acting, potent opioid analgesic remifentanil by patients to themselves (patient-controlled sedation, PCS) could be another option. Comparative studies with propofol PCS for ERCP are lacking. OBJECTIVE: To compare PCS with propofol/remifentanil to anesthesiologist-managed propofol sedation. DESIGN: Prospective, randomized, controlled human trial. SETTING: University hospital. PATIENTS: This study involved 80 patients presenting for elective ERCP. INTERVENTION: Patients were randomized to PCS with propofol/remifentanil (PCS group) or anesthesiologist-managed propofol sedation (propofol infusion group). Sedation level was estimated every 5 minutes throughout the procedure by using Ramsay and Gillham sedation scores. The total amount of propofol was calculated at the end of the procedure. Endoscopist and patient satisfaction with the procedures was evaluated with a structured questionnaire. MAIN OUTCOME MEASUREMENTS: Patient vital signs, amount of consumed propofol, sedation levels, and degree of endoscopist and patient satisfaction. RESULTS: PCS was successful with 38 of 40 (95%) ERCP patients. In the PCS group, the mean (±standard deviation) level of sedation was markedly lighter and propofol consumption significantly smaller (175±98 mg) than in the propofol infusion group (249±138 mg) (P<.01). Degrees of patient and endoscopist satisfaction were equally high in both groups. All of the patients preferred the same sedation method should a repeat ERCP be required. LIMITATIONS: Single-center study. CONCLUSION: PCS with propofol/remifentanil is a suitable and well-accepted sedation method for ERCP. Anesthesiologist-managed propofol sedation with constant propofol infusion is associated with unnecessary deep sedation without any impact on the degree of patient or endoscopist satisfaction. Further larger-scale studies are needed to assess the safety of PCS in ERCP patients. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01079312.).

[Patient controlled sedation]. / Potilassäätöinen sedaatio.

Adequate sedation is essential for successful performance of painful and uncomfortable interventional radiological, endoscopic or oncological procedures. Mild sedation is usually provided by the interventionists but an anaesthetic team is needed for deep sedation. A new alternative for intravenous sedation provided by a physician is patient controlled sedation (PCS). In PCS the patient can administer him- or herself small amounts of propofol or its combination to opioid. Spontaneous ventilation is maintained and communication with the patient is most often possible. PCS needs to be monitored adequately by an anaesthetic nurse. The advantages of PCS are appropriate level of sedation and rapid recovery. PCS has proved to be safe and effective during the change of burn injury dressings, endoscopic and radiological procedures. In Helsinki University Central Hospital the preliminary experience in over 1000 patients in the endoscopic unit has been very encouraging.

Effect and safety of 4% albumin in the treatment of cardiac surgery patients: study protocol for the randomized, double-blind, clinical ALBICS (ALBumin In Cardiac Surgery) trial.

BACKGROUND: In cardiac surgery with cardiopulmonary bypass (CPB), large amounts of fluids are administered. CPB priming with crystalloid solution causes marked hemodilution and fluid extravasation. Colloid solutions may reduce fluid overload because they have a better volume expansion effect than crystalloids. The European Medicines Agency does not recommend the use of hydroxyethyl starch solutions (HES) due to harmful renal effects. Albumin solution does not impair blood coagulation but the findings on kidney function are conflicting. On the other hand, albumin may reduce endothelial glycocalyx destruction and decrease platelet count during CPB. No large randomized, double-blind, clinical trials have compared albumin solution to crystalloid solution in cardiac surgery. METHODS/DESIGN: In this single-center, double-blind, randomized controlled trial comprising 1386 adult cardiac surgery patients, 4% albumin solution will be compared to Ringer's acetate solution in CPB priming and volume replacement up to 3200 mL during surgery and the first 24 h of intensive care unit stay. The primary efficacy outcome is the number of patients with at least one major adverse event (MAE) during 90 postoperative days (all-cause death, acute myocardial injury, acute heart failure or low output syndrome, resternotomy, stroke, major arrhythmia, major bleeding, infection compromising post-procedural rehabilitation, acute kidney injury). Secondary outcomes are total number of MAEs, incidence of major adverse cardiac events (MACE; cardiac death, acute myocardial injury, acute heart failure, arrhythmia), amount of each type of blood product transfused (red blood cells, fresh frozen plasma, platelets), total fluid balance at the end of the intervention period, total measured blood loss, development of acute kidney injury, days alive without mechanical ventilation in 90 days, days alive outside intensive care unit at 90 days, days alive at home at 90 days, and 90-day mortality. DISCUSSION: The findings of this study will provide new evidence regarding efficacy and safety of albumin solution in adult patients undergoing cardiac surgery with CPB. TRIAL REGISTRATION: EudraCT (clinicaltrialsregister.eu) 2015-002556-27 Registered 11 Nov 2016 and ClinicalTrials.gov NCT02560519. Registered 25 Sept 2015.