Different Hemostasis According to the Anesthetic Agents

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151305
• Other study ID #: ROTEM_anesthesia
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: May 27, 2014
• Start date: August 2010
• Est. completion date: April 2012

Study information

• Verified date: May 2014
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cataract
• Keratitis
• Pterygium
• Retina Detachment
• Retinal Detachment
• Vitreous Hemorrhage

Intervention

Drug:
• Propofol, remifentanil

• Sevoflurane

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clotting time of ROTEM		10 minutes before the induction of anesthesia, 1 h after finishing anesthesia	No
Primary	Clot firmness time of ROTEM		10 minutes before the induction of anesthesia, 1 h after finishing anesthesia	No
Primary	Alpha angle of ROTEM		10 minutes before the induction of anesthesia, 1 h after finishing anesthesia	No
Primary	Maximum clot firmness of ROTEM		10 minutes before the induction of anesthesia, 1 h after finishing anesthesia	No
Secondary	Hemoglobin		10 minutes before the induction of anesthesia	No
Secondary	Hematocrit		10 minutes before the induction of anesthesia	No
Secondary	Platelet count		10 minutes before the induction of anesthesia	No
Secondary	International normalized ratio of prothrombin time		10 minutes before the induction of anesthesia	No
Secondary	Activated partial thromboplastin time		10 minutes before the induction of anesthesia	No
Secondary	Fibrinogen		10 minutes before the induction of anesthesia	No