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Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution

NCT02033681 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-01-13

No results posted yet for this study

Summary

The aim of this study is to know the characteristic of "one-per-mil" tumescent solution in regards of the optimal time delay to achieve optimal visualization of operation field in hand and digit surgery.

Hypothesis:

1. Epinephine in "one-per-mil" concentration by tumescent injection technique will provide faster decrease in oxygen saturation compared to normal saline solution injected by tumescent technique.
2. Epinephrine in "one-per-mil" concentration by tumescent injection technique will provide effectiveness in vasoconstriction longer than 10 minutes as the optimal time delay.
3. Epinephine in "one-per-mil" concentration by tumescent injection technique causes no finger necrosis as normal saline solution injected by tumescent technique.

Conditions

  • Ischemia

Interventions

PROCEDURE

"One-per-mil" Tumescent Solution Injection

"One-per-mil" tumescent solution containing 1:1,000,000 epinephrine concentration in saline solution, is injected to the finger.

PROCEDURE

Saline Solution

Saline solution is injected into the tissue as a placebo control.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Theddeus OH Prasetyono, MD · Plastic Surgery Division, Faculty of Medicine University of Indonesia/Cipto Mangunkusumo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02033681 on ClinicalTrials.gov