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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02104908
Other study ID # PARA-2014
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received March 3, 2014
Last updated December 30, 2014
Start date March 2014
Est. completion date December 2014

Study information

Verified date January 2014
Source Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The investigators aim to examine target-controlled propofol infusion as a technique of anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which regional anesthesia was more sufficient for the old.


Description:

Eighty patients with American Society of Anesthesiologists(ASA) Ⅰ-Ⅲ older than 80 years are randomly assigned to 2 groups: a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus; a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1). The target-controlled propofol infusion is started immediately after positioning the patient on the operating table. The initial target concentration was 0.5μg/mL. The infusion rate is adjusted every 5min by increasing or decreasing the target concentration by 0.2μg/mL steps based on the patients' respiratory rate(RR), blood pressure(BP), heart rate(HR), and level of sedation(score of 5 on Ramsay Sedation Scale ). The minimal, maximal, optimal target concentration, cumulative propofol dose, frequency of spontaneous movement and incidences of associated complications are recorded. Patients were phoned for followup and questioned for activity status in one year. If the patients were dead, date of death; if they survived, daily living activity questioned.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 80 Years and older
Eligibility Inclusion Criteria:

- ASA ?-?

- hip fracture need surgery

Exclusion Criteria:

- patient refusal

- chronic use of opioids

- coagulation disorders

- preexisting neurological disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
paravertebral nerve
a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1).
lumbar and sacral plexus block
a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Mortality 1 year Yes
Primary cumulative propofol dose 24 weeks Yes
Secondary The optimal target concentration propofol 24 weeks Yes
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