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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01617811
Other study ID # 20120530
Secondary ID No. 2009R50040
Status Completed
Phase N/A
First received June 5, 2012
Last updated June 9, 2012
Start date August 2007
Est. completion date December 2008

Study information

Verified date June 2012
Source Sir Run Run Shaw Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to analyze the effects of epidural anesthesia and analgesia on intraoperative clinical outcome, postoperative recovery, metabolic changes, and immune functions of the patients receiving open liver resection.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- left hemihepatectomy left lateral sectionectomy clinical diagnosis of hepatolithiasis

Exclusion Criteria:

- abnormal coagulation tests diabetes mellitus significant cirrhosis

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Procedure:
epidural anesthesia and analgesia
A thoracic epidural catheter (T8-10) was placed in group E. A bolus of 8ml 1% lidocaine with 0.375% ropivacaine was administered 15min before skin incision, followed by 5-8 ml/hr infusion during surgery in group E. Postoperative analgesia by PCEA in group E (concentration: 0.1% ropivacaine + 0.1µg/ml sufentanil, loading dose: 4ml, infusion rate: 8ml/hr, bolus: 4ml, 1hr limit: 16ml) and lasting for 48hr and PCIA in group G (concentration: 1µg/ml sufentanil, loading dose: 4ml, bolus: 2ml, 4hr limit: 30ml). Both group received general anesthesia maintaining with 1-2% end tidal sevoflurane together with TCI of propofol (target plasma concentration, 2-3µg/ml), continuous infusion of remifentanil (0.10 - 0.20 µg/kg/min) and cis-atracurium intermittently as needed.

Locations

Country Name City State
China Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical outcomes during and after open liver resection intraoperative outcome including operation time, liver resection time, estimated blood loss, urine output, etc during operation. PACU recovery, pain score, liver and gastrointestinal function, hospital stay time,etc assessed.
Before operation, right after operation(0), and 3hr, 12hr, 24hr, 72hrs after operation, blood glucose and insulin was measured.
participants will be followed for the duration of hospital stay, an expected average of 4 weeks Yes
Secondary Cytokine change in perioperation of open liver resection Before operation and 0, 3hr, 12hr, 24hr, D3, D5 after operation, serum IL-1ß, IFN-?, IL-4, IL-10 and TGF-ß by microassay. Before operation, within 5 days after operation Yes
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