NCT02125188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

April 21, 2014

Last Update Submit

June 4, 2017

Conditions

Patients Undergoing Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    During Functional Endoscopic Sinus Surgery of each patient

Secondary Outcomes (1)

  • Quality of the surgical field using a scoring scale

    During Functional Endoscopic Sinus Surgery of each patient

Study Arms (2)

Desmopressin

EXPERIMENTAL

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

Drug: Desmopressin

saline

PLACEBO COMPARATOR

saline 100ml ivdrip before surgery

Drug: saline

Interventions

DesmopressinDRUG

Desmopressin 3ug/kg ivdrip before surgery

Desmopressin
salineDRUG

saline 100ml ivdrip before surgery

saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Deamino Arginine VasopressinSodium Chloride

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of anesthesiology

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 29, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

CN(1)