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Should Propofol and Alfentanil Be Combined in Patient-Controlled Sedation? A Randomised Controlled Trial Using Pharmacokinetic Simulation
Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Anaesthesiology and Intensive Care in Linköping. Linköping University, Department of Medical and Health Sciences, Division of Drug Research.
Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Anaesthesiology and Intensive Care in Linköping.
Institute of Anaesthesiology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
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2015 (English)In: Open Journal of Anesthesiology, ISSN 2164-5558, Vol. 5, no 6, 122-129 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Scientific Research Publishing , 2015. Vol. 5, no 6, 122-129 p.
Keyword [en]
Anaesthetics, Intravenous, Propofol, Analgesics, Opioids, Alfentanil, Sedation
National Category
Surgery
Identifiers
URN: urn:nbn:se:liu:diva-126606DOI: 10.4236/ojanes.2015.56023OAI: oai:DiVA.org:liu-126606DiVA: diva2:915842
Note

At the time for thesis presentation publication was in status: Manuscript

Available from: 2016-03-31 Created: 2016-03-31 Last updated: 2016-12-16Bibliographically approved
In thesis
1. Patient-controlled sedation in procedural care
Open this publication in new window or tab >>Patient-controlled sedation in procedural care
2014 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

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.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2014. 86 p.
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1423
National Category
Anesthesiology and Intensive Care
Identifiers
urn:nbn:se:liu:diva-112372 (URN)10.3384/diss.diva-112372 (DOI)978-91-7519-221-5 (ISBN)
Public defence
2015-01-23, Berzeliussalen, Campus US, Linköpings universitet, Linköping, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2014-11-24 Created: 2014-11-24 Last updated: 2016-12-16Bibliographically approved

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Nilsson, AndreasNilsson, LenaUustal, EvaSjöberg, Folke

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Faculty of Medicine and Health SciencesDepartment of Anaesthesiology and Intensive Care in LinköpingDivision of Drug ResearchDivision of Clinical SciencesDepartment of Gynaecology and Obstetrics in LinköpingDepartment of Hand and Plastic Surgery
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