Echocardiographic study of the haemodynamic effects of remifentanil with and without glycopyrrolate in healthy children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000460-90-BE

Enrollment

Registered

2006-02-07

Start date

2006-03-09

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASA I and II children

Interventions

Trade Name: Ultiva Product Name: Ultiva Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: remifentanil hydrochloride CAS Number: 132539-07-2 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I and II male and female patients, aged 1-6 years, scheduled for urological surgery Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: children with cardiac disease and diabetes

Design outcomes

Primary

Measure	Time frame
Main Objective: Remifentanil is a short acting mu opioid agonist used in general anaesthesia. Its use induces bradycardia and possibly hypotension. By associating glycopyrrolate, these side effects can be countered. This study evaluates the haemodynamic effects of this combination in healthy children by means of transthoracic echocardiography in order to determine the influence of preload, afterload and cardiac contractility.;Secondary Objective: ;Primary end point(s): Measure the effect of glycopyrrolate and remifentanil on cardiac contractility, preload and afterload, and blood pressure.	—

Measure

Time frame

Main Objective: Remifentanil is a short acting mu opioid agonist used in general anaesthesia. Its use induces bradycardia and possibly hypotension. By associating glycopyrrolate, these side effects can be countered. This study evaluates the haemodynamic effects of this combination in healthy children by means of transthoracic echocardiography in order to determine the influence of preload, afterload and cardiac contractility.;Secondary Objective: ;Primary end point(s): Measure the effect of glycopyrrolate and remifentanil on cardiac contractility, preload and afterload, and blood pressure.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026