Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01564420
  4. Details
NCT01564420 Clinical Trial

Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling

Cardiopulmonar Artery Bypass Grafting Clinical Trial

Official title:
Pharmacokinetic/Pharmacodynamic Modeling of Morphine for Postoperative Analgesia Through a Patient Controlled Device After Coronary Artery Bypass Grafting. Intrathecal Morphine Significantly Reduces Drug Consumption

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01564420
Other study ID # Santos 2012
Secondary ID
Status Completed
Phase N/A
First received March 22, 2012
Last updated March 23, 2012
Start date January 2003

Study information
Verified date March 2012
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: CONEP (Health National Council)
Study type Observational

Clinical Trial Summary

The currently available data are insufficient to develop a model that achieves optimum morphine dose individualization at the postoperative period of coronary artery bypass grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could justify morphine consumption, drug plasma concentration and pain intensity during the postoperative period after CABG and evaluate the post operative pain.

Description:

The protocol was a prospective, open-label study, approved by the institutional ethical committee of the hospital where the study was performed. Patients were randomly assigned to receive general anesthesia plus intrathecal morphine at a dosage of 400 mcg (morphine group) or general anesthesia alone (control group) according to a simple computer-generated list.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- eligible to cardiopulmonary artery bypass grafting surgery

Exclusion Criteria:

- fraction of ejection below 40%

- contraindications to neuraxial blockage

- coagulopathy

- use of low-weight heparin

- warfarin or a platelet aggregation inhibitor other than aspirin,

- systemic or local infection

- and patients with a specific contraindication on the medication employed in the study

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Cardiopulmonar Artery Bypass Grafting

Locations
Country Name City State
Brazil School of Pharmaceutical Science Sao Paulo

Sponsors (3)
Lead Sponsor Collaborator
University of Sao Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

dos Santos LM, Santos VC, Santos SR, Malbouisson LM, Carmona MJ. Intrathecal morphine plus general anesthesia in cardiac surgery: effects on pulmonary function, postoperative analgesia, and plasma morphine concentration. Clinics (Sao Paulo). 2009;64(4):27 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pain From the end of surgery until 36 hours of postoperative period two days Yes
Primary PK/PD modelling From the begin of surgery until 36 hours of postoperative period 2 days Yes
Secondary PK parameter: Cmax (peak plasma concentration) from the begin of surgery until 36 hours of postoperative period 2 days Yes
Secondary PK parameter: Tmax (time to achieve the maximum concentration) from the begin of surgery until 36 hours of postoperative period 2 days Yes
Secondary PK parameter: AUC (area under the plasma cocentration versus time curve) from the begin of surgery until 36 hours of postoperative period 2 days Yes

External Links