Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03647735
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2018-08-01
Brief Title:
Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block
Sponsor:
Universiti Kebangsaan Malaysia Medical Centre
Organization:
Universiti Kebangsaan Malaysia Medical Centre
Study Overview
Official Title:
Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block Patient-controlled Sedation Versus Target-controlled Infusion
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None