Ketamine in Alcoholic Patient and Carcinological Surgery ORL - Clinical Trials Registry

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Drug: ketamine

Detailed Description

The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine on the control of the pain (average consumption of morphine at 48 hours) at the alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA among these patients would involve it a better analgesic effectiveness and less effects dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Clermont-Ferrand, France, 63000
    - Clermont-Ferrand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

patient alcohol-dependent having to undergo a carcinological surgery ORL with tracheotomy or tracheostomy, ASA 1-3

Exclusion Criteria:

refusal of the patient
counter-indications with the treatments,
urgency
the specific clinical context (final neoplasy, reanimation)
the treatments for chronic pain containing morphinic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine consumption at 48 hours Time Frame: at 48 hours	at 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
pain Time Frame: pain	pain
the ground (dependence with alcohol) Time Frame: dependence with alcohol	dependence with alcohol
the first request analgesic Time Frame: the first request analgesic	the first request analgesic
the tolerance and the signs psychic (syndrome of weaning...) Time Frame: the tolerance and the signs psychic	the tolerance and the signs psychic
and the satisfaction of the patient Time Frame: the satisfaction of the patient	the satisfaction of the patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Nicolas Rascol, Dr, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

September 1, 2008

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria