NCT01617811

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

June 5, 2012

Last Update Submit

June 9, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cytokine change in perioperation of open liver resection

    Before operation, within 5 days after operation

Interventions

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • left hemihepatectomy left lateral sectionectomy clinical diagnosis of hepatolithiasis

You may not qualify if:

  • abnormal coagulation tests diabetes mellitus significant cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Interventions

Anesthesia, EpiduralAnalgesia

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. , Ph.D

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 12, 2012

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations