Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients (ANA06103)
Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ludwigshafen, 독일, D-67063
- Klinkum Ludwigshafen, Department of Anesthesiology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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 |
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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opioid consumption
기간: 48 hours
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48 hours
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2차 결과 측정
결과 측정 |
기간 |
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pain quality (VAS) mobilisation hemodynamics side effects
기간: operation to discharge from hospital
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operation to discharge from hospital
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공동 작업자 및 조사자
수사관
- 수석 연구원: Christoph Konrad, Prof., University Hospital Mannheim, Department of Anesthesiology
- 연구 책임자: Kerstin D. Roehm, MD, Klinikum Ludwigshafen, Department of Anesthesiology
간행물 및 유용한 링크
일반 간행물
- Passchier 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.
- 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.
- Rohm 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.
- Aiello-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.
- Rupreht J, Schneck HJ, Dworacek B. [Physostigmine--recent pharmacologic data and their significance for practical use]. Anaesthesiol Reanim. 1989;14(4):235-41. German.
연구 기록 날짜
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기본 완료 (실제)
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처음 게시됨 (추정)
연구 기록 업데이트
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추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ANA06103
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