Skip to main content
OpenTrials
Completed

NCT Number: NCT03647735

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patient-controlled Sedation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusat Perubatan Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient-controlled sedation

Other

Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2018
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.