NCT01325844

Brief Summary

This study was designed to investigate the effects of epidural anesthesia combined with general anesthesia during laparoscopic surgery. The investigators hypothesized that epidural anesthesia will effectively block the activation of the sympathetic nervous system during surgery, thus activating nitric oxide and reducing splanchnic ischemia and decrease in postoperative renal function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable prostate-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 6, 2012

Status Verified

February 1, 2012

Enrollment Period

11 months

First QC Date

March 28, 2011

Last Update Submit

February 2, 2012

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • blood pressure with heart rate variability

    10 minutes after anesthesia induction

Study Arms (2)

G group

NO INTERVENTION

G group = General anesthesia group

G+E group

EXPERIMENTAL

G+E group = General anesthesia + epidural anesthesia group

Procedure: Epidural anesthesia

Interventions

Epidural anesthesiaPROCEDURE

0.5% ropivacaine infusion via epidural catheter at 5ml/hr during general anesthesia

G+E group

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class 1 or 2 adult patients scheduled for endoscopic prostatectomy

You may not qualify if:

  • Patient refusal
  • Patients on diuretics
  • Patients with renal failure (eGFR \< 60 ml/min/1.73 m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 30, 2011

Study Start

November 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 6, 2012

Record last verified: 2012-02

Locations

KR(1)