Renal Function During Laparoscopic Surgery

Intra Operative Fluid Management Clinical Trial

Official title:

Dopamine Infusion and Crystalloids Administration Improve Renal Function During Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722630
• Other study ID #: FRF-2012-DH
• Status: Completed
• Phase: N/A
• First received: November 2, 2012
• Last updated: November 5, 2012
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Aim of this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 42 Years

Eligibility

Inclusion Criteria:

• ASA I

• age 24-42

• patients undergoing gynaecological laparoscopy

Exclusion Criteria:

• cardiovascular diseases

• renal and endocrine disorders

• obesity (BMI > 30 Kg/m2)

• the assumption of drugs that could interfere with renal parameters considered in the study

Study Design

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

Related Conditions & MeSH terms

• Intra Operative Fluid Management

Intervention

Drug:
• Dopamine

Locations

Country	Name	City	State
Italy	Catholic University of the sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimated glomerular filtration rate, tissue Doppler imaging, E/Ea	EGFr, tissue Doppler imaging and E/Ea are registered after the induction of pneumoperitoneum and Trendelemburg position, and compared to those registered before the induction of anesthesia.	patients will be followed for the duration of surgery, an expected average of 3 hours	No
Secondary	total intra operative diuresis (TID)	TID will be measured at the end of surgery	patients will be followed for the duration of surgery, an expected average of 3 hours	No