Effects of Adrenergic Drugs on the Fluid Balance During Surgery

Ovarian Cyst Clinical Trial

Official title:

The Effects of ß1-receptor Blockade and α1-adrenergic Agonist on the Kinetics of Lactated Ringer's Solution During Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431612
• Other study ID #: Esmolol study
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 6, 2011
• Last updated: September 7, 2011
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: September 2011
• Source: Sodertalje Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim this study was to examine to what degree the slow turnover of lactated Ringer's solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery performed under intravenous anesthesia.

Description:

INTRODUCTION The renal clearance of infused crystalloid fluid is very low during anaesthesia and surgery, but experiments in conscious sheep indicate that the renal fluid clearance might approach a normal rate when the adrenergic balance is modified.

METHODS Sixty females (mean age, 32 years) undergoing laparoscopic gynecological surgery were randomized to control group and received only the conventional anesthetic drugs and 20 ml/kg of lactated Ringer's over 30 min. The others were also given an infusion of 50 µg/kg/min of esmolol (beta1-receptor blocker) or 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours. The distribution and elimination of infused fluid was studied by volume kinetic analysis based on urinary excretion and blood Hgb level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• ASA group I

• Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy

Exclusion Criteria:

• ASA group > I

• Daily medication

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ovarian Cyst
• Ovarian Cysts

Intervention

Drug:
• Esmolol administration
50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours
• Phenylephrine infusion
0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine
• Lactated Ringer´s solution
Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug

Locations

Country	Name	City	State
China	Department of Anesthesiology, First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou

Sponsors (2)

Lead Sponsor	Collaborator
Sodertalje Hospital	Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (4)

Ewaldsson CA, Vane LA, Kramer GC, Hahn RG. Adrenergic drugs alter both the fluid kinetics and the hemodynamic responses to volume expansion in sheep. J Surg Res. 2006 Mar;131(1):7-14. Epub 2005 Dec 2. — View Citation

Hahn RG. Volume kinetics for infusion fluids. Anesthesiology. 2010 Aug;113(2):470-81. doi: 10.1097/ALN.0b013e3181dcd88f. — View Citation

Olsson J, Svensén CH, Hahn RG. The volume kinetics of acetated Ringer's solution during laparoscopic cholecystectomy. Anesth Analg. 2004 Dec;99(6):1854-60, table of contents. — View Citation

Vane LA, Prough DS, Kinsky MA, Williams CA, Grady JJ, Kramer GC. Effects of different catecholamines on the dynamics of volume expansion of crystalloid infusion. Anesthesiology. 2004 Nov;101(5):1136-44. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary excretion	Urine was collected via an indwelling catheter during 3 hours of surgery	3 hours	No
Secondary	Volume kinetics of lactated Ringer´s solution	Volume kinetics was analyzed based on serial analysis of the blood Hgb concentration and the collection of urine. Distribution between a central body and a peripheral body fluid space was then calculated over time.	3 hours	No