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

NCT03647735 | Completed

• 1 other identifier: FF-2017-265
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient-controlled Sedation

Outcome Measures

Primary Outcomes (1)

• total propofol requirement between PCS versus TCI sedation (TCIS)

  Total propofol requirement in both groups was calculated in mg/kg/hour.

  Assessed from the beginning to the end of sedation, at the average of 120 minutes

Secondary Outcomes (2)

• Patient satisfaction assessed by a 10-point numerical scale

  Within one hour after recovery from sedation

• 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

Study Arms (2)

Group PCS

EXPERIMENTAL

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

Group TCIS

ACTIVE COMPARATOR

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

Interventions

patient-controlled sedation OTHER

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

Group PCS; Group TCIS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Pusat Perubatan Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 18937608 RESULT

• 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.

  PMID: 24263045 RESULT

• 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.

  RESULT

Study Officials

• Nadia Md Nor, MMED(Anaes)

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 27, 2018
• Study Start: June 22, 2017
• Primary Completion: May 3, 2018
• Study Completion: May 3, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

MY (1)