Current partner codePEPTIDESDE
NCT02125188·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

60

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Desmopressin

Desmopressin 3ug/kg ivdrip before surgery

DRUG

saline

saline 100ml ivdrip before surgery

Timeline

From registration to results.

  1. First posted

    Apr 29, 2014

  2. Study start

    Jan 2014

  3. Primary completion

    Aug 2014

  4. Study completion

    Aug 2014

  5. Results posted

    Not reported

  6. Registry updated

    Jun 6, 2017

Outcomes

What the study measures.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Desmopressin.

Related PeptideStat pages

Put the record in context.

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