PainANA06103NCT00608621
Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients
An observational study of Pain, run by Klinikum Ludwigshafen at 1 site in Germany.
Trial summary
The study is to evaluate the influence of physostigmine in the postoperative period in intensive care patients considering pain quality, opioid consumption, hemodynamics and mobilisation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective major surgery, postoperative ICU patients
Who may be able to join
- Age 18-80 years
- Indication for postoperative pain therapy and admission to ICU
- ASA I-III
- Weight 50-125 kg
- Patients that are willing to participate in the present study
Who cannot join
- Peridural anesthesia for pain management
- Severe left ventricular function (EF <30%)
- Severe/exacerbated COPD; Asthma
- ASA IV-V
- Chronic renal insufficiency(Creatinine > 1,5 mg/dl)
- Ulcera ventriculi
Show all 19Show fewer
- Known allergy to any of the study agents
- Hb preoperative <9,5 g/dl
- Alcohol,drug and/or tablet abuse (Opioids, NSAR)
- Emergency operation
- Pregnancy
- Women of childbearing age and without a negative pregnancy test
- Severe liver disease (GOT oder GPT > 45 U/L)
- Severe neurologica derangements (e.g. M. Parkinson, Multiple Sklerosis)
- History of apoplexia <6 Monate or residua
- Perioperative myocardial infarction
- Patients that are not able to agree to the present study
- Patients that refuse to participate in the present study
- Patients that are part of any other study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinkum Ludwigshafen, Department of Anesthesiology
Ludwigshafen, D-67063
About this study
Official title: Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function
The study is to evaluate the influence of physostigmine in the postoperative period in intensive care patients considering pain quality, opioid consumption, hemodynamics and mobilisation.
Read the detailed description
Pain management is of major concern in the postoperative period, mostly based on opioids. In numerous experimental and clinical trials cholinergic mechanisms have been demonstrated to play an important antinociceptive role. Physostigmine, a central cholineresterase inhibitor, has been shown to produce analgesia and enhance opiate analgesia after systemic injection. This action is not based on µ-receptor (opioid) activity, but can be mostly explained by stimulation of serotonine (5-HT-3) receptors. The major withdrawal of utilizating physostigmine in postoperative care, is due to its short duration of action.
In the present study, we examined the effect of a continuous intavenous physostigmine application during a patient-controlled analgesia with piritramide for 48 hours compared to a placebo infusion with NaCl.
Major concern was set for consumption of analgesics, VAS-pain scale, hemodynamics, mobilisation and side effects.
- Conditions
- Pain
- Keywords
- physostigmine, postoperative analgesia, pain, patient-controlled analgesia, Opioid consumption, Pain quality (VAS Score), Hemodynamics, Mobilisation, Side effects
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1-physostigmine | Physostigmine 4 mg in 50 ml NaCl 0.9% per 24 h as syringe pump continuously for 48 hours, plus physostigmine 2mg (in NaCl 0.9% 50 ml)at termination of sedation PCA: Patient-controlled analgesia with piritramide 1 mg/ml, on demand: bolus of 2 mg, maximum of 10 mg in 60 min | |
| 2-placebo | NaCl 0.9% 50 ml per 24 h continuously over 48 hours, plus 50 ml NaCl 0.9% at termination of sedation PCA: Patient-controlled analgesia with piritramid 1 mg/ml, on demand: bolus of 2 mg, maximum of 10 mg in 60 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
Measured: 48 hours
Secondary outcomes (1)
pain quality (VAS) mobilisation hemodynamics side effects
Measured: operation to discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Ludwigshafen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mannheim
- Investigators
- Christoph Konrad, Prof., Principal investigator, University Hospital Mannheim, Department of AnesthesiologyKerstin D. Roehm, MD, Study director, Klinikum Ludwigshafen, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608621
- Sponsor's protocol ID
- ANA06103
- Acronym
- ANA06103
- Status last verified
- Dec 2007
- First submitted
- 23 Jan 2008
- Last updated
- 6 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Beilin B, Bessler H, Papismedov L, Weinstock M, Shavit Y. Continuous physostigmine combined with morphine-based patient-controlled analgesia in the postoperative period. Acta Anaesthesiol Scand. 2005 Jan;49(1):78-84. doi: 10.1111/j.1399-6576.2004.00548.x.
PubMed 15675987Rohm KD, Riechmann J, Boldt J, Schollhorn T, Piper SN. Retracted: Do patients profit from physostigmine in recovery from desflurane anaesthesia? Acta Anaesthesiol Scand. 2007 Mar;51(3):278-83. doi: 10.1111/j.1399-6576.2006.01238.x. Epub 2007 Jan 23.
PubMed 17250745Aiello-Malmberg P, Bartolini A, Bartolini R, Galli A. Effects of morphine, physostigmine and raphe nuclei stimulation on 5-hydroxytryptamine release from the cerebral cortex of the cat. Br J Pharmacol. 1979 Apr;65(4):547-55. doi: 10.1111/j.1476-5381.1979.tb07863.x.
PubMed 435680Passchier J, Rupreht J, Koenders ME, Olree M, Luitwieler RL, Bonke B. Patient-controlled analgesia (PCA) leads to more postoperative pain relief, but also to more fatigue and less vigour. Acta Anaesthesiol Scand. 1993 Oct;37(7):659-63. doi: 10.1111/j.1399-6576.1993.tb03784.x.
PubMed 8249554Rupreht J, Schneck HJ, Dworacek B. [Physostigmine--recent pharmacologic data and their significance for practical use]. Anaesthesiol Reanim. 1989;14(4):235-41. German.
PubMed 2675888
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function
- ClinicalTrials.gov ID
- NCT00608621
- Acronym / sponsor ID
- ANA06103 / ANA06103
- Conditions
- Pain
- Keywords
- physostigmine, postoperative analgesia, pain, patient-controlled analgesia, Opioid consumption, Pain quality (VAS Score), Hemodynamics, Mobilisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Klinikum LudwigshafenUniversity, hospital or other
- Collaborators
- University of Mannheim
- Study start
- Jan 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to evaluate the influence of physostigmine in the postoperative period in intensive care patients considering pain quality, opioid consumption, hemodynamics and mobilisation.
Detailed description
Pain management is of major concern in the postoperative period, mostly based on opioids. In numerous experimental and clinical trials cholinergic mechanisms have been demonstrated to play an important antinociceptive role. Physostigmine, a central cholineresterase inhibitor, has been shown to produce analgesia and enhance opiate analgesia after systemic injection. This action is not based on µ-receptor (opioid) activity, but can be mostly explained by stimulation of serotonine (5-HT-3) receptors. The major withdrawal of utilizating physostigmine in postoperative care, is due to its short duration of action.
In the present study, we examined the effect of a continuous intavenous physostigmine application during a patient-controlled analgesia with piritramide for 48 hours compared to a placebo infusion with NaCl.
Major concern was set for consumption of analgesics, VAS-pain scale, hemodynamics, mobilisation and side effects.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-physostigmine | – | –Physostigmine 4 mg in 50 ml NaCl 0.9% per 24 h as syringe pump continuously for 48 hours, plus physostigmine 2mg (in NaCl 0.9% 50 ml)at termination of sedation PCA: Patient-controlled analgesia with piritramide 1 mg/ml, on demand: bolus of 2 mg, maximum of 10 mg in 60 min |
| 2-placebo | – | –NaCl 0.9% 50 ml per 24 h continuously over 48 hours, plus 50 ml NaCl 0.9% at termination of sedation PCA: Patient-controlled analgesia with piritramid 1 mg/ml, on demand: bolus of 2 mg, maximum of 10 mg in 60 min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective major surgery, postoperative ICU patients
Key inclusion criteria (5 listed)
- Age 18-80 years
- Indication for postoperative pain therapy and admission to ICU
- ASA I-III
- Weight 50-125 kg
- Patients that are willing to participate in the present study
Key exclusion criteria (19 listed)
- Peridural anesthesia for pain management
- Severe left ventricular function (EF <30%)
- Severe/exacerbated COPD; Asthma
- ASA IV-V
- Chronic renal insufficiency(Creatinine > 1,5 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
opioid consumption
Time frame: 48 hours
1 secondary outcome
pain quality (VAS) mobilisation hemodynamics side effects
Time frame: operation to discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2008.
- Background: PubMed 15675987Beilin B, Bessler H, Papismedov L, Weinstock M, Shavit Y. Continuous physostigmine combined with morphine-based patient-controlled analgesia in the postoperative period. Acta Anaesthesiol Scand. 2005 Jan;49(1):78-84. doi: 10.1111/j.1399-6576.2004.00548.x.
- Background: PubMed 17250745Rohm KD, Riechmann J, Boldt J, Schollhorn T, Piper SN. Retracted: Do patients profit from physostigmine in recovery from desflurane anaesthesia? Acta Anaesthesiol Scand. 2007 Mar;51(3):278-83. doi: 10.1111/j.1399-6576.2006.01238.x. Epub 2007 Jan 23.
- Background: PubMed 435680Aiello-Malmberg P, Bartolini A, Bartolini R, Galli A. Effects of morphine, physostigmine and raphe nuclei stimulation on 5-hydroxytryptamine release from the cerebral cortex of the cat. Br J Pharmacol. 1979 Apr;65(4):547-55. doi: 10.1111/j.1476-5381.1979.tb07863.x.
- Background: PubMed 8249554Passchier J, Rupreht J, Koenders ME, Olree M, Luitwieler RL, Bonke B. Patient-controlled analgesia (PCA) leads to more postoperative pain relief, but also to more fatigue and less vigour. Acta Anaesthesiol Scand. 1993 Oct;37(7):659-63. doi: 10.1111/j.1399-6576.1993.tb03784.x.
- Background: PubMed 2675888Rupreht J, Schneck HJ, Dworacek B. [Physostigmine--recent pharmacologic data and their significance for practical use]. Anaesthesiol Reanim. 1989;14(4):235-41. German.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Konrad, Prof. principal investigator
University Hospital Mannheim, Department of Anesthesiology
Kerstin D. Roehm, MD study director
Klinikum Ludwigshafen, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Klinikum Ludwigshafen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00608621, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2008.