UMIN-CTR Clinical Trial

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

hip osteoarthritis

Classification by specialty

Orthopedics

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Asahikawa Medical University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

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

Date of disclosure of the study information

2016

Year

08

Month

18

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2016

Year

07

Month

18

Day

Last modified on

2018

Year

07

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026762