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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023218
Receipt No. R000026762
Scientific Title A comparison of propofol vs. dexmedetomidine for sedation and contribution to perioperative analgesia for lumbar plexus block
Date of disclosure of the study information 2016/08/18
Last modified on 2018/07/24

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Basic information
Public title A comparison of propofol vs. dexmedetomidine for sedation and contribution to perioperative analgesia for lumbar plexus block
Acronym Sedation drug for lumbar plexus block
Scientific Title A comparison of propofol vs. dexmedetomidine for sedation and contribution to perioperative analgesia for lumbar plexus block
Scientific Title:Acronym Sedation drug for lumbar plexus block
Region
Japan

Condition
Condition hip osteoarthritis
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare propofol group with dexmedetomidine group as sedatives at lumbar plexus block. The main endpoints are the amount of analgesics in perioperative periods, pain score(VAS), timing of getting out of the bed, and satisfaction
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain score(VAS) 24 hour after surgery
Key secondary outcomes Pain score(VAS) soon, 4 hour, and 48hour after surgery
Timing of getting out of bed, satisfaction, the amount of analgesics

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The computer randomly assign patients to the dexmedetomidine group (group D, n=26) or the propofol group (group P, n=26). Anesthesiologist is blinded from the administration. Evaluation of the quality of sedation are based on an Observer's Assessment of Alertness/Sedation Scale (OAA/S). Group D receive dexmedetomidine at a loading dose of 6 mcg/kg/hr for 10 minutes followed by 0.2-0.7mcg/kg/hr infusion until the OAA/S score reached 2-4. The ultrasound-guided lumbar plexus block using nerve stimulator is performed while sedation with each one. 30 ml of 0.375% levobupivacaine are administered and a catheter inserted through the needle.
Then general anesthesia are induced including continuous infusion of propofol, 0.3 mcg /kg/min remifentanil, and 0.6 mg/kg rocuronium and followed by tracheal intubation. Propofol are modurated at an effect-site concentration of 1.5-3.5 mcg/mL to maintain the bispectral index within the recommended range (40-60). For analgesia, 0.1-0.5 mcg /kg/min remifentanil are titrated and 3-5mcg /kg intravenous fentanyl are administered as needed. All patients undergo the standard surgical procedure of total hip arthoplasty as determined by the surgeons. All patients are extubated at the end of surgery, and a continuous infusion of 0.1% levobupivacaine are started in the operating room at 6 ml/kg/h and continued on the ward. All catheters are continued for 72 h.
Pain, the amount of analgesics, the timing of out of bed, and the incidence of complications at 4, 24, and 48 hours after the operation are assessed. Pain are assessed by the attending anesthesiologist using visual analog scale (VAS; 10cm-scale where 0 = no pain and 10 = worst pain).
Interventions/Control_2 Anesthesiologist is blinded from the administration. Evaluation of the quality of sedation are based on an Observer's Assessment of Alertness/Sedation Scale (OAA/S). Group P receive propofol at an effect-site concentration of 0.5-3 mcg/mL by target controlled infusion with Schneider pharmacokinetic model to maintain 2-4 points as OAA/S score.
The ultrasound-guided lumbar plexus block using nerve stimulator is performed while sedation with each one. 30 ml of 0.375% levobupivacaine are administered and a catheter inserted through the needle.
Then general anesthesia are induced including continuous infusion of propofol, 0.3 mcg /kg/min remifentanil, and 0.6 mg/kg rocuronium and followed by tracheal intubation. Propofol are modurated at an effect-site concentration of 1.5-3.5 mcg/mL to maintain the bispectral index within the recommended range (40-60). For analgesia, 0.1-0.5 mcg /kg/min remifentanil are titrated and 3-5 mcg /kg intravenous fentanyl are administered as needed. All patients undergo the standard surgical procedure of total hip arthoplasty as determined by the surgeons. All patients are extubated at the end of surgery, and a continuous infusion of 0.1% levobupivacaine are started in the operating room at 6 ml/kg/h and continued on the ward. All catheters are continued for 72 h.
Pain, the amount of analgesics, the timing of out of bed, and the incidence of complications at 4, 24, and 48 hours after the operation are assessed. Pain are assessed by the attending anesthesiologist using visual analog scale (VAS; 10cm-scale where 0 = no pain and 10 = worst pain).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have total hip arthroplasty by general anesthesia using lumbar plexus block
Key exclusion criteria Patients who have had alpha 2 agonist and/or antagonist, same side hip operation before the operation, anatomical abnormalities at their loins, neurological abnormalities, severe heart and/or renal failure, vasopressors in the operation, continuous unstable hemodynamic parameter (sBP>200, sBP<80, HR<40), disagreement with our study.
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Tada
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2583
Email a070026@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tada
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2583
Homepage URL
Email a070026@yahoo.co.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 旭川医科大学(北海道) Asahikawa medical university(Hokkaido)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 18 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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