Different Hemostasis According to the Anesthetic Agents

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02151305
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
20
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Clotting time of ROTEM [10 minutes before the induction of anesthesia, 1 h after finishing anesthesia]

  2. Clot firmness time of ROTEM [10 minutes before the induction of anesthesia, 1 h after finishing anesthesia]

  3. Alpha angle of ROTEM [10 minutes before the induction of anesthesia, 1 h after finishing anesthesia]

  4. Maximum clot firmness of ROTEM [10 minutes before the induction of anesthesia, 1 h after finishing anesthesia]

Secondary Outcome Measures

  1. Hemoglobin [10 minutes before the induction of anesthesia]

  2. Hematocrit [10 minutes before the induction of anesthesia]

  3. Platelet count [10 minutes before the induction of anesthesia]

  4. International normalized ratio of prothrombin time [10 minutes before the induction of anesthesia]

  5. Activated partial thromboplastin time [10 minutes before the induction of anesthesia]

  6. Fibrinogen [10 minutes before the induction of anesthesia]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Seoul National University Bundang HospitalSeongnamGyeonggiKorea, Republic of463-707

Sponsors and Collaborators

  • Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hyo-Seok Na, Pf, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT02151305
Other Study ID Numbers:
  • ROTEM_anesthesia
First Posted:
May 30, 2014
Last Update Posted:
May 30, 2014
Last Verified:
May 1, 2014

Study Results

No Results Posted as of May 30, 2014