Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block
Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block: Patient-controlled Sedation Versus Target-controlled Infusion
연구 개요
상세 설명
Central neuraxial block (CNB) is one of the mainstays of anaesthesia methods in various disciplines particularly orthopaedic surgeries. However the state of consciousness can potentially cause patient anxiety thus sedation is often utilized as a mean to improve patient satisfaction and increase patient acceptance of CNB.
Conventionally, the anaesthesiologist administers sedatives for the patients. Propofol is the commonly used drug for sedation due to its favourable pharmacokinetic profile, which results in fast induction, easy control of depth of sedation and rapid recovery. It can be infused by using target-controlled infusion (TCI) devices where the anaesthetists titrates propofol by setting desired target plasma and effect site concentration. However it is difficult to judge precisely patient requirements for adequate patient sedation, comfort and analgesia as patients' needs differ.
Patient-controlled sedation (PCS) is a valid option, initially adapted from post surgery patient-controlled analgesia. It allows patients to titrate sedative medication to their comfort and therefore present an option that addresses the needs of patients with strong desire to maintain sense of control during procedures.
This study was designed to compare total propofol requirement between PCS versus TCI sedation (TCIS), complications and patient satisfaction, in patients undergoing lower limb orthopaedic surgery under CNB.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kuala Lumpur
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Cheras, Kuala Lumpur, 말레이시아, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I or II.
- Aged 18-65 years.
- Elective lower limb orthopaedic surgery under CNB anticipated to last for 1.5 to 2 hours
Exclusion Criteria:
- Body Mass Index (BMI) > 30kg/m2
- Unable to cooperate (eg. mental disorders, language barrier)
- Drug abuse
- Alcoholism (chronic daily alcohol intake greater than 75 g of pure alcohol for ≥ 2 years, where 75g of alcohol = 5 cans of beer, 1 bottle of wine or half a pint of distilled spirit)
- Contraindications to the study drugs
- Pregnancy
- Significant pulmonary or cardiovascular diseases, including obstructive sleep apnoea and obesity hypoventilation syndrome
- Features of difficult airway
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group PCS
Patients in Group PCS (patient-controlled sedation) received intravenous (IV) propofol via a patient controlled analgesia (PCA) infusion pump.
The machine was set to deliver a demand bolus dose of 0.25 mg/kg with 1-minute lockout interval, without basal infusion.The patient was instructed to press on a hand-held device as often as required, to achieve their desired level of comfort or sedation.
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Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
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활성 비교기: Group TCIS
Patients in Group TCIS (target-controlled infusion sedation) received IV propofol via a target-controlled infusion (TCI) pump, targeted at an initial effect site concentration (Cet) of 0.6 μg/ml, using the Schnider pharmacokinetic model.
Upon attainment of 0.6 μg/ml Cet, the patient's sedation level was assessed.
The Cet was increased or reduced accordingly by 0.2 μg/ml to attain an OAA/S score of 3.
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Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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total propofol requirement between PCS versus TCI sedation (TCIS)
기간: Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Total propofol requirement in both groups was calculated in mg/kg/hour.
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Assessed from the beginning to the end of sedation, at the average of 120 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient satisfaction assessed by a 10-point numerical scale
기간: Within one hour after recovery from sedation
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Assessed using a 10-point verbal numerical rating scale (1 to 10), where 1 was regarded as extremely dissatisfied and 10 extremely satisfied.
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Within one hour after recovery from sedation
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Complications including incidence of hypotension, bradycardia, hypopnea, oxygen desaturation and over sedation
기간: Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Documented as Yes or No for each specified complication
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Assessed from the beginning to the end of sedation, at the average of 120 minutes
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nadia Md Nor, MMED(Anaes), Universiti Kebangsaan Malaysia Medical Centre
간행물 및 유용한 링크
일반 간행물
- Wahlen BM, Kilian M, Schuster F, Muellenbach R, Roewer N, Kranke P. Patient-controlled versus continuous anesthesiologist-controlled sedation using propofol during regional anesthesia in orthopedic procedures--a pilot study. Expert Opin Pharmacother. 2008 Nov;9(16):2733-9. doi: 10.1517/14656566.9.16.2733.
- Ekin A, Donmez F, Taspinar V, Dikmen B. Patient-controlled sedation in orthopedic surgery under regional anesthesia: a new approach in procedural sedation. Braz J Anesthesiol. 2013 Sep-Oct;63(5):410-4. doi: 10.1016/j.bjan.2012.07.012.
- Singh T, Ravishankar M. Conscious sedation with propofol for surgeries under spinal anaesthesia: anaesthesiologist versus patient controlled. J Anaesthesiol Clin Pharmacol. 21:169-173, 2005.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FF-2017-265
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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