Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery

NCT ID: NCT02125188

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-08-31

Brief Summary

Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons and anesthesiologists despite several measures available for improving the surgical field. This study was conducted to evaluate the effect of desmopressin on blood loss and the quality of the surgical field in FESS.

Detailed Description

Desmopressin, a synthetic analogue of vasopressin, has been employed as a non-transfusional treatment for hemophilia and von Willebrand's disease. Hemostatic effects of desmopressin include: 1) an increase in plasma factors through endogenous release of coagulation factor VIII, von Willebrand factor and tissue plasminogen activator; 2) an increase in platelet adhesiveness; and 3) a reduction in bleeding time. Randomized, double-blind studies have been performed on patients undergoing various types of surgical procedures. A study in patients undergoing orthognathic surgery showed a significant reduction in intraoperative blood loss and a study in patients undergoing lumbar fusion concluded that desmopressin was effective in reducing intraoperative blood loss. The purpose of this study was to investigate the effect of administration of desmopressin on intraoperative blood loss in patients undergoing FESS.

Conditions

Patients Undergoing Endoscopic Sinus Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Desmopressin

Desmopressin 3ug/kg in saline 100ml ivdrip before surgery

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

Desmopressin 3ug/kg ivdrip before surgery

saline

saline 100ml ivdrip before surgery

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

saline 100ml ivdrip before surgery

Interventions

Desmopressin

Desmopressin 3ug/kg ivdrip before surgery

Intervention Type: DRUG

saline

saline 100ml ivdrip before surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists physical status I-II
• aged 18-60 years

Exclusion Criteria

• Patients receiving anticoagulants
• medically important liver or kidney dysfunction
• significant heart disease
• allergy to Desmopressin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tao Zhang

OTHER

Sponsor Role: lead

Responsible Party

Tao Zhang

Department of anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

desmopressinFESS

Identifier Type: -

Identifier Source: org_study_id