Completed

NCT Number: NCT02125188

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

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.

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Key information

Conditions

Patients Undergoing Endoscopic Sinus Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desmopressin

Drug

Desmopressin 3ug/kg ivdrip before surgery

Saline

Drug

saline 100ml ivdrip before surgery

Primary outcomes

Blood loss

Time frame: During Functional Endoscopic Sinus Surgery of each patient

Secondary outcomes

Quality of the surgical field using a scoring scale

Time frame: During Functional Endoscopic Sinus Surgery of each patient

The overall quality of the surgical field was assessed on a scoring scale adapted from Boezaart et al. The following are the scoring scale:

0-1: No bleeding; excellent to outstanding surgical conditions; 2-3: Slight bleeding; surgery fairly easy. No stops for hemostasis and/or suctioning are required; 4-5: Slight bleeding; surgery mildly difficult. One stop for hemostasis and/or suctioning is required; 6-7: Moderate bleeding; surgery moderately difficult. Occasional stops for hemostasis and/or suctioning are required; 8-9: Moderate to severe bleeding; surgery very difficult. Multiple stops for hemostasis and/or suctioning are required; 10: Surgery terminated due to severe bleeding in the surgical field.

Sponsors and collaborators

Lead sponsor

Tao Zhang

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Apr 29, 2014
Registry last updated: Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.