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

Not Applicable

Completed

• Conditions: Patient-controlled Sedation
• Interventions: Other: patient-controlled sedation

• Registration Number: NCT03647735
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-06-22
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-03
• Status Verified: 2018-08
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Study First Posted: 2018-08-27
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group PCS	patient-controlled sedation	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.
Group TCIS	patient-controlled sedation	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.

Primary Outcome Measures

Name	Time	Method
total propofol requirement between PCS versus TCI sedation (TCIS)	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

Name	Time	Method
Patient satisfaction assessed by a 10-point numerical scale	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.
Complications including incidence of hypotension, bradycardia, hypopnea, oxygen desaturation and over sedation	Assessed from the beginning to the end of sedation, at the average of 120 minutes	Documented as Yes or No for each specified complication

Trial Locations

Locations (1)

Pusat Perubatan Universiti Kebangsaan Malaysia; 🇲🇾 Cheras, Kuala Lumpur, Malaysia