NCT04948957

Brief Summary

The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

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

March 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

1.8 years

First QC Date

June 12, 2021

Last Update Submit

June 22, 2021

Conditions

Hypotension; ControlledCognitive Dysfunction

Keywords

cerebral oxygenationcognitive functionesmololnitroglycerine

Outcome Measures

Primary Outcomes (1)

  • effects of controlled hypotension on cerebral oxygen saturation

    influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by measuring regional cerebral oxygen saturation using Near-Infrared Spectroscopy

    until end of the surgical procedure.

Secondary Outcomes (1)

  • effects of controlled hypotension on cognitive function

    24 hour before surgery and 24 hour after surgery

Study Arms (2)

esmolol (Group E)

Drug: Esmolol

nitroglycerin (Group N)

Drug: Nitroglycerin

Interventions

EsmololDRUG
esmolol (Group E)
NitroglycerinDRUG
nitroglycerin (Group N)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\- required controlled hypotension scheduled for nasal surgeries

You may qualify if:

  • written informed consent
  • patients with ASA physical status of I-II
  • aged 18-65 years

You may not qualify if:

  • Age under 18 or above 65
  • ASA \> II
  • coagulation disorders
  • history of cardiovascular and cerebrovascular disease
  • poor Blood Pressure control
  • anemia, pregnancy, addiction to opioids
  • body mass index (BMI) \> 35
  • intraoperative systolic BP \< 65 mmHg
  • surgical duration less than 30 minutes or more than 160 minutes
  • need for an intraoperative sympathomimetic drug and the use of other hypotensive drugs
  • preoperative Mini-Mental State Examination (MMSE) score of 23 or less.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypotensionCognitive Dysfunction

Interventions

esmololNitroglycerin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 12, 2021

First Posted

July 2, 2021

Study Start

March 1, 2014

Primary Completion

January 1, 2016

Study Completion

August 1, 2016

Last Updated

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Locations

TU(1)