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Trial · Interventional

CompletedPhase 4Registry data

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

Overview

Status
Completed
Phase
Phase 4
Enrollment
60 participants (estimated)
Sponsor
Tao Zhang · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
Jan 2014
Primary completion
Aug 2014
Completion
Aug 2014
First posted
29 Apr 2014 (estimated)
Last update posted
6 Jun 2017
Conditions
Patients Undergoing Endoscopic Sinus Surgery

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 4

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

    NCT02125188

    Jan 2014 to Aug 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DesmopressinDrug
  • salineDrug

Arms2

  • Experimental

    Desmopressin

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

  • Placebo comparator

    saline

    saline 100ml ivdrip before surgery

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Blood loss

    Time frame · During Functional Endoscopic Sinus Surgery of each patient

Secondary outcomes(1)
  1. Quality of the surgical field using a scoring scale

    Time frame · During Functional Endoscopic Sinus Surgery of each patient

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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