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

Phase 4

Completed

• Conditions: Patients Undergoing Endoscopic Sinus Surgery
• Interventions: Drug: Desmopressin; Drug: saline

• Registration Number: NCT02125188
• Lead Sponsor: Tao Zhang

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-29
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-04
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Blood loss	During Functional Endoscopic Sinus Surgery of each patient

Secondary Outcome Measures

Name	Time	Method
Quality of the surgical field using a scoring scale	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.

Trial Locations

Locations (1)

First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China