Trial document




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  DRKS00013158

Trial Description

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Title

Influence of perinterventional acupuncture on the incidence of postoperative delirium after elective, endoprosthetic replacement of the hip joint

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We would like to investigate whether acupuncture can affect the development or the expression of a delirium in patients who are scheduled for elective hip joint replacement. For this purpose, a group is randomized with or without prior acupuncture. In the acupuncture group, acupuncture is performed at several body sites just before the start of the operation. The above mentioned acupuncture is an East Asian healing method in which therapeutic effects are to be achieved by needle sticks at certain points of the body.. Patients of the acupuncture group receive an acupuncture needle with the following electrostimulation for 30 minutes at varying frequencies (2Hz / 100Hz) according to the tolerance and acceptance of the patient. The stimulation intensity is strictly set to 0-10V and 0-20 mA according to the patient's tolerance. As a tolerance level, the individual current strength, which is still indicated by the awake patient as "sustainable", is selected. Frequencies of 2 Hz and 100 Hz are used alternately (so-called HAN mode). After identification of the desired acupuncture points according to the meridian rules of Traditional Chinese Medicine, the detailed disinfection of the areas to be punctured is performed. The needles are inserted into the skin, the needle sensitivity De Qi confirms the correct positioning. Each needle is connected to the electrostimulation device, with a slow increase in the stimulation intensity, the acceptable tolerance level of the patient is determined and held. The electrical stimulation is started and maintained for 30 minutes. The needles are then removed without complications. Patients of the control group instead receive 30 minutes rest prior to induction of anesthesia.. Subsequently, anesthesia is initiated immediately. The anesthesiological and operative staff involved in the operation has no knowledge of which of the two groups, acupuncture group or rest group, the patient has been randomized and is not involved in the study.
After an acupuncture, anesthesia and surgery are performed as scheduled. After the operation and 24 and 48 hours later, a member of the study team will examine the patient for signs of a delirium using a questionnaire. This examination usually takes about five minutes. Neither the anesthesiologist, nor the member of the study team knows whether or not the patient has received acupuncture.

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Brief Summary in Scientific Language

Postoperative delirium is a common problem in elderly patients. However, their effects may be very serious for patients, and in some cases may even have a drastic effect on life quality or life expectancy. The incidence of postoperative delirium in elderly patients is 10-25%, and after total endoprothetic hip replacement up to 82%. The postoperative delirium is a frequent, but also life-threatening complication. It is manifested by a functional disorder of the brain. Patients suffer from disorientation, restlessness, hallucinations or anxiety. Often, a postoperative delirium is detected to late and / or a successful intervention is delayed. The more time elapsed before the diagnosis, the more aggressive and risky the therapy has to be and the more the patient's life risk increases. From previous studies it is known that the plasma levels of the neuron-specific enolase (NSE) and S-100 β protein can correlate with a postoperative delirium. Otherwise, there are no valid laboratory tests for the diagnosis.
Apart from an avoidance strategy of possible triggering drugs, there are therefore no sensible preventive strategies.

A recent meta-analysis of our working group around Asmussen et al. showed that in the case of neurosurgical patients, the marker for a possible brain damage "S100ß" was significantly lower in the case of neurological acupuncture than in the control groups with complete anesthesia alone. Li et al. confirmed this effect on S100 in a study among seniors for hip replacement surgery. A recent review by Liodden et al. to outpatient surgery also concludes that patients benefit from additional acupuncture with regard to anxiety and perioperative delirium.

To enable rapid diagnosis and therapy, it is also essential to know the exact biochemical processes of a delirium. An important role in the development of postoperative delirium seems to be both the neuroinflammation and cholinergic receptors, which react to the neurotransmitters acetylcholine and butyrylcholine. Animal-experimental studies demonstrate that stimulation of the immune system during an operative procedure promotes the formation of TNF-α, and thus the hemophilia barrier for defense cells, e.g. Macrophages become permeable, so that a cell migration into the hippocampus takes place. This can lead to a delirium. The activation of the nicotinic acetylcholine receptor 7 (nAChR7), on the other hand, leads to the inhibition of TNF-α release and can thus prevent delirium. The regulation of the expression of acetylcholinesterase (ACHE), butyrylcholinesterase (BCHE) and nAChR7 therefore appear to be an important mechanism. Because patients suffer from cognitive deficits after a long period, longer-term changes in expression seem to occur. It seems therefore possible that anesthetics regulate pathways of inflammation and acetylcholinesterase levels by epigenetic processes.

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Organizational Data

  •   DRKS00013158
  •   2017/10/23
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  •   yes
  •   Approved
  •   17-6009, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   F05 -  Delirium, not induced by alcohol and other psychoactive substances
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Interventions/Observational Groups

  •   The acupuncture is carried out as standardized by the same investigator. The performing physician, Dr. med. Sven Asmussen, received the acupuncture diploma of the CBIATC (Chinese Beijing International Acupuncture Training Center) in 2004, in Beijing, China, as well as the acupuncture diploma in Baden-Württemberg, Germany in 2009. The evaluation of the acupuncture points is performed according to Traditional Chinese Medicine (TCM) at the following points: DU20, EX-HN3, H7, L3, LI4, K3 (Q: Matsumoto-Miyazaki J et al, 255-268). Patients of the interventional group receive before induction of anesthesia the installation of the acupuncture needles with directly following electrostimulation for 30 minutes with alternating frequencies (2Hz / 100Hz) according to the patient's adjusted tolerance. The electroacupuncture TENS stimulator E600 HAN (TENS Plus Ind. Co., Hong Kong, PRC) is used for electrostimulation. The stimulation intensity is strictly set to 0-10V and 0-20 mA according to the patient's tolerance. As a tolerance level, the individual current strength, which is still indicated as "sustainable" by the awake patient, is selected. Frequencies of 2 Hz and 100 Hz are used alternately (so-called HAN mode). After anatomical identification of the desired acupuncture points according to the meridian rules of the TCM, the detailed disinfection of the areas to be punctured takes place. The needles are inserted into the skin, the needle sensitivity De Qi confirms the correct positioning. Each needle is connected to the E600 HAN and the acceptable tolerance level of the patient is determined and held with a slow increase in the stimulation intensity. The frequency-alternating stimulation (2Hz / 100Hz) is started and maintained for 30 minutes. The needles are then removed.
  •   the control group does not receive acupuncture
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Incidence of postoperative delirium after total hip joint replacement

Preoperative, when transferred from the recovery room and 24 h and 48 h postoperatively, the Delire estimation is performed according to the "Confusion Assessment Method" for intensive care units (CAM-ICU)

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Secondary Outcome

o Activity of acetylcholineestrase (ACHE) and butyrylcholinesterase (BCHE) in the blood
o Determination TNFα, NSE, S-100 β protein
o Epigenetic markers such as DNA methylation, acetylation, and histone modifications
o Hospital lenght of stay

These analyses are made at 4 times (during premedication, directly postoperatively, first and second postoperative day) with 15 ml of venous whole blood.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/01/01
  •   135
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients scheduled for total endoprothetic hip Joint replacement were included

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Exclusion Criteria

o Age <65 years
o Pre-existing dementia
o immunosuppression
o Chronic skin diseases
o Rejection by patients
o Previous participation in this study
o Drugaddicted patients , psychosis
o Patients with heart pacemaker and deep brain stimulation
o Existing anticholinergic medication

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Addresses

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    • Universitätsklinikum Knappschaftskrankenhaus Bochum, Universitätsklinikum der Ruhr-Universität Bochum
    • Mr.  Prof. Dr. med.  Michael  Adamzik 
    • In der Schornau 23-25
    • 44892  Bochum
    • Germany
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    • Universitätsklinikum Knappschaftskrankenhaus Bochum, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
    • Mr.  Dr. med.  Lars  Bergmann 
    • In der Schornau 23-25
    • 44982  Bochum
    • Germany
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    • Universitätsklinikum Knappschaftskrankenhaus Bochum, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
    • Mr.  Dr. med.  Lars  Bergmann 
    • In der Schornau 23-25
    • 44982  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Knappschaftskrankenhaus Bochum-Langendreer
    • Mr.  Prof. Dr. med.  Michael   Adamzik 
    • In der Schornau 23-25
    • 44892  Bochum
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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