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Preemptive Analgesia With Morphine Sulphate in Major Urological Surgery

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ClinicalTrials.gov Identifier: NCT02041988
Recruitment Status : Unknown
Verified January 2014 by Francesco Cannata, University of Roma La Sapienza.
Recruitment status was:  Recruiting
First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Francesco Cannata, University of Roma La Sapienza

Brief Summary:
In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce opioids administration during major urological surgery

Condition or disease
Pain

Detailed Description:
The administration of oral morphine sulfate could be useful to reduce the use of opioids in major urological surgery. This study aims to assess the safety and efficacy of two different oral morphine sulphate doses 0,2 mg/kg vs 0,4mg/kg in major urological surgery.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Official Title: Influence of Premedication With Oral Morphine Sulphate on Analgesic Consumption in Patient Undergoing Major Urological Surgery. Comparison Between Two Different Doses
Study Start Date : February 2013
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Group/Cohort
0,2 mg/kg oral morphine
Patients have been assigned to two groups of 20 individuals, they have been premedicated with oral morphine sulfate, 0,2 mg/kg group A, 0,4mg/kg group B.During surgery analgesic administration will be monitored
0,4 mg/ kg oral morphine
morphine and analgesic consumption throughout surgery will be monitored



Primary Outcome Measures :
  1. morphine sulphate consumption [ Time Frame: six months ]

Secondary Outcome Measures :
  1. vital signs [ Time Frame: six months ]

Other Outcome Measures:
  1. VAS score [ Time Frame: six months ]
  2. side effects [ Time Frame: six months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients selected for major urological surgery
Criteria

Inclusion Criteria:

American Society of Anaesthesiologists physical status classification I/ II, age between 18 - 75, BMI 18 -30

Exclusion Criteria:

American Society of Anaesthesiologists physical status classification III/ IV, renal and hepatic insufficiency, postoperative nausea and vomiting after oral opioids administrations, neurological and psychiatric disorders.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041988


Contacts
Contact: Francesco FC Cannata, MD +390649970283 francesco.cannata@uniroma1.it

Locations
Italy
Francesco Cannata Recruiting
Rome, Italy, 00141
Contact: Francesco FC Cannata, MD    +390649970283    francesco.cannata@uniroma1.it   
Policlinico Umberto I Recruiting
Rome, Italy, 00141
Contact: Francesco FC Cannata, MD    +390649970283    francesco.cannata@uniroma1.it   
Principal Investigator: Francesco FC Cannata, MD         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Francesco MD Cannata, MD Policlinico Umberto I

Responsible Party: Francesco Cannata, Medical Doctor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02041988     History of Changes
Other Study ID Numbers: 1846/08.04.10
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Francesco Cannata, University of Roma La Sapienza:
premedication
oral morphine
preemptive analgesia

Additional relevant MeSH terms:
Morphine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents