Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
Primary Purpose
Patients Undergoing Endoscopic Sinus Surgery
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Desmopressin
saline
Sponsored by

About this trial
This is an interventional prevention trial for Patients Undergoing Endoscopic Sinus Surgery
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
Sites / Locations
- First Affiliated Hospital, Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Desmopressin
saline
Arm Description
Desmopressin 3ug/kg in saline 100ml ivdrip before surgery
saline 100ml ivdrip before surgery
Outcomes
Primary Outcome Measures
Blood loss
Secondary Outcome Measures
Quality of the surgical field using a scoring scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02125188
Brief Title
Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
Official Title
Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao Zhang
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Endoscopic Sinus Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desmopressin
Arm Type
Experimental
Arm Description
Desmopressin 3ug/kg in saline 100ml ivdrip before surgery
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
saline 100ml ivdrip before surgery
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Intervention Description
Desmopressin 3ug/kg ivdrip before surgery
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
saline 100ml ivdrip before surgery
Primary Outcome Measure Information:
Title
Blood loss
Time Frame
During Functional Endoscopic Sinus Surgery of each patient
Secondary Outcome Measure Information:
Title
Quality of the surgical field using a scoring scale
Description
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.
Time Frame
During Functional Endoscopic Sinus Surgery of each patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
We'll reach out to this number within 24 hrs