Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00792779
Other study ID # CAAE - 0023.0.263.000-08
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 17, 2008
Last updated November 4, 2009
Start date November 2008
Est. completion date June 2009

Study information

Verified date November 2009
Source Centro Medico Campinas
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if propofol could protect erythrocytes by directly scavenging free radicals from the blood current and increasing resistance of their cell membranes in patients submitted to gastroplasty.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date June 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- patients between BMI 40-50 kg/m2

Exclusion Criteria:

- patients with BMI under 40 kg/m2 and over 50 kg/m2

- alcohol users

- illicit-drug users

- patients in regular use of anti-depressants, proton bomb inhibitors or calcium canal blockers

- patients transfused either recently, during the intra-operative period or within 10 hours post-operative

- patients previously known to be hypersensitive to any drug that is used during the study

- patients with any psychiatric disorder or dementia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Propofol
Patients in the Propofol Group (PG) will be induced with target-controlled infusion (TCI) of propofol (Diprifusor, AstraZeneca) and remifentanil (Asena PK, Cardinal Health) at the target dose of 6.0 µg.ml-1 and 8.0 ?g.ml-1, respectively. The patients in the Sevoflurane Group (SG) will be induced with remifentanil TCI at target dose of 8.0 ?g.ml-1 and etomidate 0.5 mg.kg-1 in bolus.

Locations

Country Name City State
Brazil Fundação Centro Médico de Campinas Campinas São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Centro Medico Campinas

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Tsuchiya M, Asada A, Kasahara E, Sato EF, Shindo M, Inoue M. Antioxidant protection of propofol and its recycling in erythrocyte membranes. Am J Respir Crit Care Med. 2002 Jan 1;165(1):54-60. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Count erythrocytes After 10 hours post-surgery Yes
Secondary Bilirubins(direct and indirect) After 10 hours post-surgery Yes
See also
  Status Clinical Trial Phase
Completed NCT03439605 - Effect of in Vitro Haemolysis on Serum High Sensitivity Troponin T Measurements From Patients in Accident & Emergency N/A
Completed NCT03434145 - Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases N/A
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Not yet recruiting NCT01201174 - Hemolysis in Patients With Hereditary Spherocytosis (HS) N/A
Completed NCT03582592 - Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease on Hemodialysis N/A
Not yet recruiting NCT05754294 - Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
Completed NCT02996786 - Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners N/A
Completed NCT02259478 - Isoagglutinins in the Development of IVIG-associated Hemolysis N/A
Not yet recruiting NCT05647200 - Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part II N/A
Completed NCT05962268 - The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs N/A
Recruiting NCT06223802 - Biodex Training in Hemodialysis Females With Osteopenia N/A
Not yet recruiting NCT06096428 - Hemolysis During Pulsed-field and Radiofrequency Ablation
Recruiting NCT03330223 - Effect of Haemodialysis on the Efficacy of Antiplatelet Agents N/A
Completed NCT04203784 - Meropenem and Piperacillin Plasma Concentrations During CRRT
Completed NCT06215339 - Diet Therapy in Hemodialysis Patients N/A
Recruiting NCT05539248 - A Study on the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CAN106 in Subjects With PNH Phase 1/Phase 2
Recruiting NCT03633435 - Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation N/A
Withdrawn NCT02217683 - Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion Phase 2
Completed NCT03199612 - Sildenafil To Prevent Clot Early Phase 1
Completed NCT02711332 - Investigating the Influence of Haemolysis on the Potassium Concentration After Capillary Blood Sampling N/A