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Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block

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ClinicalTrials.gov Identifier: NCT03647735
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

Brief Summary:
Orthopaedic surgeries involving the legs can be done under nerve block, where patients will be numb of pain at the operated site but awake during surgery. Sedation can be given to allay anxiety and provide comfort throughout the surgery. Sedation can be given by the anaesthetic doctors by using target-comtrolled infusion pump, or self-administered by patients by means of specialised machines. This study compares two method of administration of sedation, patient-controlled sedation (PCS) versus target-controlled infusion sedation (TCIS) by anaesthetic doctors, in people undergoing orthopaedic surgeries under nerve block.

Condition or disease Intervention/treatment Phase
Patient-controlled Sedation Other: patient-controlled sedation Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block: Patient-controlled Sedation Versus Target-controlled Infusion
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 3, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: 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.
Other: patient-controlled sedation
Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block

Active Comparator: 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.
Other: patient-controlled sedation
Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block




Primary Outcome Measures :
  1. total propofol requirement between PCS versus TCI sedation (TCIS) [ Time Frame: Assessed from the beginning to the end of sedation, at the average of 120 minutes ]
    Total propofol requirement in both groups was calculated in mg/kg/hour.


Secondary Outcome Measures :
  1. Patient satisfaction assessed by a 10-point numerical scale [ Time Frame: Within one hour after recovery from sedation ]
    Assessed using a 10-point verbal numerical rating scale (1 to 10), where 1 was regarded as extremely dissatisfied and 10 extremely satisfied.

  2. Complications including incidence of hypotension, bradycardia, hypopnea, oxygen desaturation and over sedation [ Time Frame: Assessed from the beginning to the end of sedation, at the average of 120 minutes ]
    Documented as Yes or No for each specified complication



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) I or II.
  2. Aged 18-65 years.
  3. Elective lower limb orthopaedic surgery under CNB anticipated to last for 1.5 to 2 hours

Exclusion Criteria:

  1. Body Mass Index (BMI) > 30kg/m2
  2. Unable to cooperate (eg. mental disorders, language barrier)
  3. Drug abuse
  4. 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)
  5. Contraindications to the study drugs
  6. Pregnancy
  7. Significant pulmonary or cardiovascular diseases, including obstructive sleep apnoea and obesity hypoventilation syndrome
  8. Features of difficult airway

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647735


Locations
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Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
Investigators
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Principal Investigator: Nadia Md Nor, MMED(Anaes) Pusat Perubatan Universiti Kebangsaan Malaysia
  Study Documents (Full-Text)

Documents provided by Universiti Kebangsaan Malaysia Medical Centre:

Publications of Results:
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Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT03647735     History of Changes
Other Study ID Numbers: FF-2017-265
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics