Different Hemostasis According to the Anesthetic Agents

May 27, 2014 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.

We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patient scheduled for ophthalmic surgery under general anesthesia
  • American Society of Anesthesiologist physical status I or II

Exclusion Criteria:

  • hematologic disorder
  • severe anemia
  • liver disease
  • kidney disease
  • taking a medication interfering with hemostasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total intravenous anesthesia group
This group received propofol and remifentanil for the maintenance of general anesthesia.
Drug: Propofol, remifentanil
Experimental: Inhalation anesthesia group
This group received sevoflurane for the maintenance of general anesthesia.
Drug: Sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clotting time of ROTEM
Time Frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Clot firmness time of ROTEM
Time Frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Alpha angle of ROTEM
Time Frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Maximum clot firmness of ROTEM
Time Frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin
Time Frame: 10 minutes before the induction of anesthesia
10 minutes before the induction of anesthesia
Hematocrit
Time Frame: 10 minutes before the induction of anesthesia
10 minutes before the induction of anesthesia
Platelet count
Time Frame: 10 minutes before the induction of anesthesia
10 minutes before the induction of anesthesia
International normalized ratio of prothrombin time
Time Frame: 10 minutes before the induction of anesthesia
10 minutes before the induction of anesthesia
Activated partial thromboplastin time
Time Frame: 10 minutes before the induction of anesthesia
10 minutes before the induction of anesthesia
Fibrinogen
Time Frame: 10 minutes before the induction of anesthesia
10 minutes before the induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Estimate)

May 30, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROTEM_anesthesia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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