Different Hemostasis According to the Anesthetic Agents

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02151305
Collaborator
(none)
66
1
2
20
3.3

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 Disease Intervention/Treatment Phase
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

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

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

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam Gyeonggi Korea, Republic of 463-707

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