NCT01052337

Brief Summary

Aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

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

April 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

January 20, 2010

Status Verified

December 1, 2009

Enrollment Period

11 months

First QC Date

January 12, 2010

Last Update Submit

January 19, 2010

Conditions

Spinal Cord Diseases

Outcome Measures

Primary Outcomes (1)

  • episode of severe arterial hypotension

    at 0 minut, after 3 minuts, after 5 minuts

Secondary Outcomes (1)

  • the incidence and duration of apnoea and the incidence of induction complications such as laryngospasm, coughing and patient movement during fiberoptic intubation.

    at 0 minuts , at 5 minuts

Study Arms (2)

propofol

ACTIVE COMPARATOR
Drug: anaesthetics: sevofluorane

sevofluorane

ACTIVE COMPARATOR
Drug: anaesthetics: sevofluorane

Interventions

anaesthetics: sevofluoraneDRUG

0.5%of sevofluorane with air

propofolsevofluorane

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing cervical spine surgery;
  • Male or female;
  • Aged 18-75 years.

You may not qualify if:

  • Severe cardiovascular pathology;
  • Liver disease;
  • Renal disease;
  • BMI \>35;
  • Allergies to any anaesthetic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico UMBERTO I

Rome, Rome, 00100, Italy

RECRUITING

MeSH Terms

Conditions

Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Central Study Contacts

Federico F Bilotta

CONTACT

+39 339 33 70 822bilotta@tiscali.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 20, 2010

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Last Updated

January 20, 2010

Record last verified: 2009-12

Locations

IT(1)