Patient-controlled SedationNCT03647735
Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block
A study of Patient-controlled Sedation, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient-controlled Sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteMalaysia
- Study dates
- 22 Jun 2017to 3 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Pusat Perubatan Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, 56000
About this study
Official title: Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block: Patient-controlled Sedation Versus Target-controlled Infusion
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.
Read the 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.
- Conditions
- Patient-controlled Sedation
- Being tested
- patient-controlled sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-controlled sedationOther
Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: patient-controlled sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
total propofol requirement between PCS versus TCI sedation (TCIS)
Total propofol requirement in both groups was calculated in mg/kg/hour.
Measured: 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
Assessed using a 10-point verbal numerical rating scale (1 to 10), where 1 was regarded as extremely dissatisfied and 10 extremely satisfied.
Measured: Within one hour after recovery from sedation
Complications including incidence of hypotension, bradycardia, hypopnea, oxygen desaturation and over sedation
Documented as Yes or No for each specified complication
Measured: Assessed from the beginning to the end of sedation, at the average of 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start22 Jun 2017
- Primary completion3 May 2018
- Study completion3 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient-controlled SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Md Nor, MMED(Anaes), Principal investigator, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647735
- Sponsor's protocol ID
- FF-2017-265
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18937608Ekin 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.
PubMed 24263045Singh T, Ravishankar M. Conscious sedation with propofol for surgeries under spinal anaesthesia: anaesthesiologist versus patient controlled. J Anaesthesiol Clin Pharmacol. 21:169-173, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block: Patient-controlled Sedation Versus Target-controlled Infusion
- ClinicalTrials.gov ID
- NCT03647735
- Acronym / sponsor ID
- FF-2017-265
- Conditions
- Patient-controlled Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PCS | Experimental | Other: patient-controlled sedationPatients 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 | Active comparator | Other: patient-controlled sedationPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient-controlled sedationPatient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block | Other | Group PCS, Group TCIS |
Primary outcome
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.
2 secondary outcomes
Patient satisfaction assessed by a 10-point numerical scale
Time frame: Within one hour after recovery from sedation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Results publication: PubMed 18937608Wahlen 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.
- Results publication: PubMed 24263045Ekin 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.
- Results publicationSingh T, Ravishankar M. Conscious sedation with propofol for surgeries under spinal anaesthesia: anaesthesiologist versus patient controlled. J Anaesthesiol Clin Pharmacol. 21:169-173, 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Md Nor, MMED(Anaes) principal investigator
Universiti Kebangsaan Malaysia Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Patient-controlled Sedation, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03647735, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.