Doris Østergaard

Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents

Based on an international consensus conference held in Copenhagen in the autumn of 1994, a set of guidelines for Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents are presented. The guidelines are intended to be a help for people working in this research field, and it is hoped that the guidelines will assist researchers, editors, and drug companies to enhance the quality of their pharmacodynamic studies of neuromuscular blocking agents.

Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study.

Background: Sugammadex (Org 25969) forms a complex with steroidal neuromuscular blocking agents, thereby reversing neuromuscular block. This study investigated the dose–response relation, safety, and pharmacokinetics of sugammadex to reverse rocuronium-induced block. Methods: Twenty-seven male surgical patients aged 18–64 yr were randomly assigned to receive placebo or sugammadex (0.5, 1.0, 2.0, 3.0, or 4.0 mg/kg) for reversal of 0.6 mg/kg rocuronium–induced neuromuscular block. Anesthesia was induced and maintained using intravenous fentanyl and propofol. Neuromuscular function was assessed using acceleromyography. Sugammadex or placebo was administered at reappearance of T2 of the train-of-four. The primary efficacy variable was the time required for recovery to a train-of-four ratio of 0.9. Results: Sugammadex decreased median recovery time in a dose-dependent manner from 21.0 min in the placebo group to 1.1 min in the group receiving 4.0 mg/kg sugammadex. Doses of sugammadex of 2.0 mg/kg or greater reversed rocuronium-induced neuromuscular block within 3 min. A median of 59–77% of sugammadex was excreted unchanged in the urine within 16 h, mostly in the first 8 h. Sugammadex increased the proportion of the rocuronium dose excreted unchanged in the urine (from a median of 19% in the placebo group to 53% in the 4.0-mg/kg group within 16 h). Sugammadex was safe and well tolerated. No evidence of recurarization was observed in any patient. Conclusion: At doses of 2.0 mg/kg or greater, sugammadex safely reversed 0.6 mg/kg rocuronium–induced neuromuscular block in a dose-dependent manner. Sugammadex enhanced renal excretion of rocuronium and was excreted unchanged by the kidneys.

The art and science of debriefing in simulation: Ideal and practice

Objectives: Describing what simulation centre leaders see as the ideal debriefing for different simulator courses (medical vs. crisis resource management (CRM)-oriented). Describing the practice of debriefing based on interactions between instructors and training participants. Methods: Study 1 – Electronic questionnaire on the relevance of different roles of the medical teacher for debriefing (facilitator, role model, information provider, assessor, planner, resource developer) sent to simulation centre leaders. Study 2 – Observation study using a paper-and-pencil tool to code interactions during debriefings in simulation courses for CRM for content (medical vs. CRM-oriented) and type (question vs. utterance). Results: Study 1 – The different roles were seen as equally important for both course types with the exception of ‘information provider’ which was seen as more relevant for medical courses. Study 2 – There were different interaction patterns during debriefings: line – involving mostly the instructor and one course participant, triangle – instructor and two participants, fan – instructor and all participants in a dyadic form and net – all participants and the instructor with cross references. Conclusion: What simulation centre heads think is important for the role mix of simulation instructors is (at least partly) not reflected in debriefing practice.

Diclofenac or acetaminophen for analgesia in paediatric tonsillectomy outpatients

Background: In order to establish an effective drug regimen, we compared the analgesic efficacy of oral diclofenac and high‐dose acetaminophen on pain after tonsillectomy.

Half-life of plasma cholinesterase

The half–life of plasma cholinesterase (acylcholine acylhydrolase EC 3.1.1.8) was determined in three patients homozygous for the atypical gene for plasma cholinesterase by measuring the rate of disappearance of enzyme activity following intravenous injection of concentrated human cholinesterase. Half–life values of 10.9, 11.1, and 11.3 days were estimated. The distribution volume was estimated to be 18.0, 18.2, and 13.8% of body weight, respectively.

Descriptions of verbal communication errors between staff. An analysis of 84 root cause analysis-reports from Danish hospitals

Introduction Poor teamwork and communication between healthcare staff are correlated to patient safety incidents. However, the organisational factors responsible for these issues are unexplored. Root cause analyses (RCA) use human factors thinking to analyse the systems behind severe patient safety incidents. The objective of this study is to review RCA reports (RCAR) for characteristics of verbal communication errors between hospital staff in an organisational perspective. Method Two independent raters analysed 84 RCARs, conducted in six Danish hospitals between 2004 and 2006, for descriptions and characteristics of verbal communication errors such as handover errors and error during teamwork. Results Raters found description of verbal communication errors in 44 reports (52%). These included handover errors (35 (86%)), communication errors between different staff groups (19 (43%)), misunderstandings (13 (30%)), communication errors between junior and senior staff members (11 (25%)), hesitance in speaking up (10 (23%)) and communication errors during teamwork (8 (18%)). The kappa values were 0.44–0.78. Unproceduralized communication and information exchange via telephone, related to transfer between units and consults from other specialties, were particularly vulnerable processes. Conclusion With the risk of bias in mind, it is concluded that more than half of the RCARs described erroneous verbal communication between staff members as root causes of or contributing factors of severe patient safety incidents. The RCARs rich descriptions of the incidents revealed the organisational factors and needs related to these errors.

Incidence, staff awareness and mortality of patients at risk on general wards

UNLABELLED The aim of this study was to estimate the incidence, staff awareness and subsequent mortality of patients with abnormal vital signs on general wards in a Danish university hospital. DESIGN AND SETTINGS Prospective data collection in two surgical and three medical wards at Herlev University Hospital, Copenhagen. Study personnel measured vital signs of all patients present on the wards at random points during the evening and interviewed nursing staff about patients with abnormal vital signs. Simplified medical emergency team (MET) calling criteria were used to define abnormal vital signs. INTERVENTIONS None. RESULTS During the 2-month data collection period, 877 patients were included in the study and 155 (18%) had abnormal vital signs. The 30-day mortality in this group was 13% compared to 5% among patients with normal vital signs (p<0.0001). Of the 155 patients with abnormal signs, nursing staff were not aware of all of the patients abnormalities in 67 (43%) cases. For 20 patients (13%), staff were aware of some of their abnormalities, while for 52 patients (34%), staff were aware of all their abnormalities. CONCLUSIONS One out of five patients in the general wards developed abnormal vital signs during the 2-month study period and these patients had a 3-fold increased 30-day mortality. For almost half of the patients, nursing staff were unaware of their abnormal vital signs. Strategies to improve identification of patients at risk should be an initial step in preventing serious adverse events on the general wards.

Implementation of team training in medical education in Denmark

In the field of medicine, team training aiming at improving team skills such as leadership, communication, co-operation, and followership at the individual and the team level seems to reduce risk of serious events and therefore increase patient safety. The preferred educational method for this type of training is simulation. Team training is not, however, used routinely in the hospital. In this paper, we describe a framework for the development of a team training course based on need assessment, learning objectives, educational methods including full-scale simulation and evaluations strategies. The use of this framework is illustrated by the present multiprofessional team training in advanced cardiac life support, trauma team training and neonatal resuscitation in Denmark. The challenges of addressing all aspects of team skills, the education of the facilitators, and establishment of evaluation strategies to document the effect of the different types of training on patient safety are discussed.

Setting a research agenda for simulation-based healthcare education: a synthesis of the outcome from an Utstein style meeting.

Although the use of simulation as a methodology for learning continues to grow at a rapid pace throughout all of the healthcare professions and disciplines, research in this field is still at an early stage. Increasingly, decision makers and stakeholders must see evidence that the use of such a meth

Mivacurium‐induced neuromuscular blockade in patients with atypical plasma cholinesterase

The duration of action of mivacurium was evaluated during a modified neurolept anaesthesia in 17 patients heterozygous for the usual and the atypical plasma cholinesterase (pChe) gene (Ea1Ea1) and in five patients homozygous for the atypical gene (Ea1Ea1). The response to train‐of‐four nerve stimulation was recorded using a Myograph 2000. Five heterozygous patients were given a small dose of mivacurium 0.03 mg kg bw‐1 intravenously (Group 1). The mean (range) suppression of the first twitch in the train‐of‐four response (T1) was 91% (69–100%). The time to 90% T1 recovery was 23.9 min (14.0–31.3 min). Twelve other heterozygous patients (Group 2) received mivacurium 0.2 mg kg bw‐1 (2.5 * ED95). In these patients the time to 100% T1 suppression was 1.4 min (1.1–2.0 min). The time to reappearance of the T1 response, to 90% T1 recovery, and the recovery index (25.3 min (14.5–34.5), 45.5 min (30.9–59.2), and 9.8 min (6.8–19.6), respectively) were significantly longer than reported in phenotypically normal patients. Five patients homozygous for the atypical gene (Group 3) were given 0.03 mg kg bw‐1 mivacurium. The time to reappearance of T1 response following this low dose of mivacurium ranged from 26–128 min. In all five patients the neuromuscular block was successfully antagonized with neostigmine preceded by atropine. In conclusion, mivacurium‐induced neuromuscular blockade was moderately prolonged in patients heterozygous for the usual and the atypical gene for plasma cholinesterase. Patients homozygous for the atypical plasma cholinesterase gene appear to be markedly sensitive to mivacurium.