NCT03815435

Brief Summary

The work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 21, 2019

Last Update Submit

March 29, 2023

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Surgical field clarityEndonasal surgeryIntraoperative bleeding

Outcome Measures

Primary Outcomes (1)

  • Surgical field clarity in relation to the value of arterial pressure

    Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)

    13 months

Secondary Outcomes (14)

  • Blood pressure

    13 months

  • Heart rate

    13 months

  • Depth of anaesthesia

    13 months

  • Near infrared spectroscopy (NIRS)

    13 months

  • Consumption of hypotensives

    13 months

  • +9 more secondary outcomes

Study Arms (1)

Controlled hypotension

EXPERIMENTAL

Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).

Procedure: Controlled hypotension

Interventions

Controlled hypotensionPROCEDURE

Controlled hypotension will be administered according to the clarity of the surgical field.

Controlled hypotension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic rhinosinusitis undergoing pansinusoperation
  • Age over 18 years
  • Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)
  • Concrete anaesthetist (Michal Parma, MD)

You may not qualify if:

  • Coagulopathy
  • Thrombocytopathies
  • Vascular wall disorders
  • Thrombophlebitis
  • Anticoagulation or anti-aggregation therapy
  • History of malignancy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (4)

  • Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.

    PMID: 23844295BACKGROUND

  • Kelly EA, Gollapudy S, Riess ML, Woehlck HJ, Loehrl TA, Poetker DM. Quality of surgical field during endoscopic sinus surgery: a systematic literature review of the effect of total intravenous compared to inhalational anesthesia. Int Forum Allergy Rhinol. 2013 Jun;3(6):474-81. doi: 10.1002/alr.21125. Epub 2012 Dec 19.

    PMID: 23258603BACKGROUND

  • Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764.

    PMID: 17989575BACKGROUND

  • Milonski J, Zielinska-Blizniewska H, Golusinski W, Urbaniak J, Sobanski R, Olszewski J. Effects of three different types of anaesthesia on perioperative bleeding control in functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2045-50. doi: 10.1007/s00405-012-2311-1. Epub 2012 Dec 22.

    PMID: 23263204BACKGROUND

MeSH Terms

Conditions

DiseaseBlood Loss, Surgical

Interventions

Hypotension, Controlled

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHemorrhageIntraoperative Complications

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Ondřej Jor, MD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The physician performing the surgery and assessing the surgical field clarity will be masked as to the value of the blood pressure in the individual patient.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study subjects will be enrolled into one arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 24, 2019

Study Start

January 1, 2019

Primary Completion

January 31, 2020

Study Completion

March 31, 2020

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations

CZ(1)