NCT02592915

Brief Summary

The purpose of this study is to assess the effect of IV clonidine administration on lower limb spinal motoneuron excitability during standardized total intravenous anesthesia (propofol and remifentanil).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

7.2 years

First QC Date

October 20, 2015

Last Update Submit

January 28, 2020

Conditions

Intraoperative Neurophysiological MonitoringPain Management

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration.

    continuously during the surgery

  • Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration

    continuously during the surgery

Secondary Outcomes (4)

  • Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period

    perioperative period, up to 5H

  • Pain score using the Children Hospital of Eastern Ontario Pain Scale (CHEOPS) or EVA scale

    Every 30 minutes during the recovey period (up to 2H)

  • Sedative score using the University of Michigan Sedation Scale (UMSS) scale

    Every 30 minutes during the recovery period (up to 2H)

  • Total dose of step 2 analgesic (tramadol) used for pain management

    Total dose given during the recovery period (up to 2H)

Study Arms (2)

Test Group

EXPERIMENTAL

Patients randomized in the Test Group will receive the clonidine hydrochloride

Drug: Clonidine hydrochloride

Control Group

PLACEBO COMPARATOR

Patients randomized in the Control Group will receive the Placebo

Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level

Interventions

Clonidine hydrochlorideDRUG

Single bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level

Test Group
Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic levelOTHER
Control Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged 6 to 18 years at time of hospital admission
  • Planned hospital admission for tympanoplasty
  • Informed Consent signed by both parents

You may not qualify if:

  • Known hypersensitivity to clonidine or to any component of the Catapressan
  • Patient treated with alpha2 agonists
  • Surgical emergency
  • Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant)
  • Abnormal heart rhythms
  • Neuromuscular disease
  • Renal impairment
  • Patient treated with methylphenidate
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Fabiola Children's University Hospital

Brussels, 1020, Belgium

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Françoise De Pooter, MD

CONTACT

0032 3 477 39 96francoise.depooter@huderf.be

Philippe Van der Linden, PhD

CONTACT

0032 2 477 23 30philippe.vanderlinden@chu-brugmann.be

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

BE(1)