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Patient-controlled sedation in procedural care
Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Anaesthetics, Operations and Specialty Surgery Center, Department of Anaesthesiology and Intensive Care in Linköping.
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: urn:nbn:se:liu:diva-112372DOI: 10.3384/diss.diva-112372ISBN: 978-91-7519-221-5 (print)OAI: oai:DiVA.org:liu-112372DiVA: diva2:765699
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
List of papers
1. Patient controlled sedation using a standard protocol for dressing changes in burns: Patients' preference, procedural details and a preliminary safety evaluation
Open this publication in new window or tab >>Patient controlled sedation using a standard protocol for dressing changes in burns: Patients' preference, procedural details and a preliminary safety evaluation
2008 (English)In: Burns, ISSN 0305-4179, E-ISSN 1879-1409, Vol. 34, no 7, 929-934 p.Article in journal (Refereed) Published
Abstract [en]

Background: Patient controlled sedation (PCS) enables patients to titrate doses of drugs by themselves during different procedures involving pain or discomfort. Methods: We studied it in a prospective crossover design using a fixed protocol without lockout time to examine it as an alternative method of sedation for changing dressings in burned patients. Eleven patients with >10% total burn surface area (TBSA) had their dressings changed, starting with sedation by an anaesthetist (ACS). The second dressing change was done with PCS (propofol/alfentanil) and the third time the patients had to choose ACS or PCS. During the procedures, data on cardiopulmonary variables, sedation (bispectral index), pain intensity (VAS), procedural details, doses of drugs, and patients' preferences were collected to compare the two sedation techniques. Results: The study data indicated that wound care in burned patients is feasible with a standardized PCS protocol. The patients preferred PCS to ACS on the basis of self-control, and because they had less discomfort during the recovery period. Wound care was also considered adequate by the staff during PCS. No respiratory (respiratory rate/transcutaneous PCO2) or cardiovascular (heart rate/blood pressure) adverse events were recorded at any time during any of the PCS procedures. The doses of propofol and alfentanil and BIS index decrease were less during PCS than ACS. Procedural pain was higher during PCS but lower after the procedure. Conclusion: We suggest that PCS using a standard protocol is an interesting alternative to anaesthetist-provided sedation during dressing changes. It seems effective, saves resources, is safe, and at same time is preferred by the patients. The strength of these conclusions is, however, hampered by the small size of this investigation and therefore further studies are warranted. © 2008 Elsevier Ltd and ISBI.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-43402 (URN)10.1016/j.burns.2008.04.002 (DOI)73753 (Local ID)73753 (Archive number)73753 (OAI)
Available from: 2009-10-10 Created: 2009-10-10 Last updated: 2017-12-13
2. Alfentanil and patient-controlled propofol sedation – facilitate gynaecological outpatient surgery with increased risk of respiratory events
Open this publication in new window or tab >>Alfentanil and patient-controlled propofol sedation – facilitate gynaecological outpatient surgery with increased risk of respiratory events
2012 (English)In: Acta Anaesthesiologica Scandinavica, ISSN 0001-5172, E-ISSN 1399-6576, Vol. 56, no 9, 1123-1129 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Wiley-Blackwell, 2012
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-84741 (URN)10.1111/j.1399-6576.2012.02749.x (DOI)000308635200007 ()
Note

Funding Agencies|Department of Anesthesiology and Intensive Care, Linkoping University Hospital, Linkoping, Sweden|581 85|

Available from: 2012-10-19 Created: 2012-10-19 Last updated: 2017-12-07
3. Should Propofol and Alfentanil Be Combined in Patient-Controlled Sedation? A Randomised Controlled Trial Using Pharmacokinetic Simulation
Open this publication in new window or tab >>Should Propofol and Alfentanil Be Combined in Patient-Controlled Sedation? A Randomised Controlled Trial Using Pharmacokinetic Simulation
Show others...
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
Keyword
Anaesthetics, Intravenous, Propofol, Analgesics, Opioids, Alfentanil, Sedation
National Category
Surgery
Identifiers
urn:nbn:se:liu:diva-126606 (URN)10.4236/ojanes.2015.56023 (DOI)
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
4. 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, 1285-1292 p.Article 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
Keyword
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: 2017-12-05Bibliographically approved

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