UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparison of propofol vs. dexmedetomidine for sedation and contribution to perioperative analgesia for lumbar plexus block
Title of the study (Brief title)	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	Masahiro Tada
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
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	Masahiro Tada
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026762