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Procedural sedation: Aspects on methods, safety and effectiveness
Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Anaesthesiology and Intensive Care in Linköping (ANOPIVA).
2019 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background: Safety and effectiveness are fundamental principles within the healthcare sector to provide quality of care and health improvement for patients. By ensuring that care is provided based on evidence-based knowledge, risks and complications can be minimised and the use of scarce resources optimised. An increasing demand for diagnostic and therapeutic procedures challenges the traditional methods for sedation regarding safety and effectiveness. It is desirable that the fundamental principles are improved when refining existing or developing new sedation methods. In this doctoral thesis, safety and effectiveness were evaluated for adult patient-controlled sedation (PCS) using propofol during two endoscopic procedures: endoscopic retrograde cholangiopancreaticography (ERCP) and flexible bronchoscopy (FB); and different doses of rectal racemic ketamine for paediatric (< 4 years) burn wound care.

Methods: Data on vital functions, sedation level, safety interventions, procedure feasibility, patient-reported outcome and experience measures, and recovery, from three clinical randomised controlled trials were collected. Costs of sedation for the endoscopic procedures were compiled in a cost-analysis study.

Results: PCS with propofol and bedside anaesthetic personnel was shown to be a safe and effective alternative method of sedation during ERCP and FB compared with intravenous sedation with midazolam. The PCS method gives stable cardiorespiratory conditions with few adverse events and interventions, with a low risk of oversedation. PCS offers similar (FB) or better (ERCP) procedure feasibility and patient satisfaction during the procedures than midazolam. Recovery after PCS is quick, minimises the risk for prolonged hospitalisation and is thereby a potential cost-saving sedation method. The optimal dose of rectal racemic ketamine, 6 mg/kg with the addition of 0.5 mg/kg midazolam during severely painful procedures, gives minimal risk for outbreaks of pain, offers stable vital signs conditions and allows rapid recovery without affecting procedure feasibility.

Conclusions: The sedation method can be adjusted to type of procedure and patient population. PCS with propofol offers an alternative and reliable method for adult sedation during endoscopic procedures, whereas rectal racemic ketamine combined with midazolam provides good conditions for burn care dressing procedures in young children.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2019. , p. 85
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1669
National Category
Anesthesiology and Intensive Care Surgery Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
URN: urn:nbn:se:liu:diva-156720DOI: 10.3384/diss.diva-156720ISBN: 9789176851104 (print)OAI: oai:DiVA.org:liu-156720DiVA, id: diva2:1315254
Public defence
2019-06-05, Berzeliussalen, Campus US, Linköping, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2019-05-13 Created: 2019-05-13 Last updated: 2019-10-24Bibliographically approved
List of papers
1. Sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled study of patient-controlled propofol sedation and that given by a nurse anaesthetist
Open this publication in new window or tab >>Sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled study of patient-controlled propofol sedation and that given by a nurse anaesthetist
Show others...
2015 (English)In: Scandinavian Journal of Gastroenterology, ISSN 0036-5521, E-ISSN 1502-7708, Vol. 50, no 10, p. 1285-1292Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Taylor & Francis, 2015
Keywords
Conscious sedation, propofol, Cholangiopancreatography, Endoscopic Retrograde
National Category
Anesthesiology and Intensive Care
Identifiers
urn:nbn:se:liu:diva-112371 (URN)10.3109/00365521.2015.1038848 (DOI)000361324600013 ()
Available from: 2014-11-24 Created: 2014-11-24 Last updated: 2019-05-13Bibliographically approved
2. Patient-controlled Sedation During Flexible Bronchoscopy: A Randomized Controlled Trial
Open this publication in new window or tab >>Patient-controlled Sedation During Flexible Bronchoscopy: A Randomized Controlled Trial
2019 (English)In: Journal of Bronchology & Interventional Pulmonology, ISSN 1944-6586, E-ISSN 1948-8270Article in journal (Refereed) Epub ahead of print
Abstract [en]

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.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2019
Keywords
analgesia, patient-controlled, conscious sedation, anesthesia, intravenous, bronchoscopy, propofol
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:liu:diva-161081 (URN)10.1097/LBR.0000000000000610 (DOI)31478938 (PubMedID)2-s2.0-85072015123 (Scopus ID)
Available from: 2019-10-21 Created: 2019-10-21 Last updated: 2019-10-28Bibliographically approved
3. Patient-controlled sedation with propofol for endoscopic procedures: A cost analysis
Open this publication in new window or tab >>Patient-controlled sedation with propofol for endoscopic procedures: A cost analysis
Show others...
2019 (English)In: Acta Anaesthesiologica Scandinavica, ISSN 0001-5172, E-ISSN 1399-6576Article in journal (Refereed) Epub ahead of print
Abstract [en]

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.

Place, publisher, year, edition, pages
John Wiley & Sons, 2019
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:liu:diva-161080 (URN)10.1111/aas.13463 (DOI)31436310 (PubMedID)
Available from: 2019-10-21 Created: 2019-10-21 Last updated: 2019-10-28Bibliographically approved
4. Rectal ketamine during paediatric burn wound dressing procedures: a randomised dose-finding study
Open this publication in new window or tab >>Rectal ketamine during paediatric burn wound dressing procedures: a randomised dose-finding study
2019 (English)In: Burns, ISSN 0305-4179, E-ISSN 1879-1409, Vol. 45, no 5, p. 1081-1088Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Pergamon Press, 2019
National Category
Anesthesiology and Intensive Care Public Health, Global Health, Social Medicine and Epidemiology Surgery
Identifiers
urn:nbn:se:liu:diva-156837 (URN)10.1016/j.burns.2018.12.012 (DOI)000470856100010 ()31060760 (PubMedID)2-s2.0-85065014700 (Scopus ID)
Note

Funding agencies: County Council of Ostergotland, Sweden

Available from: 2019-05-14 Created: 2019-05-14 Last updated: 2019-07-15Bibliographically approved

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