Clinical trial NCT01431612: Effects of Adrenergic Drugs on the Fluid Balance During Surgery
Official title: The Effects of ß1-receptor Blockade and α1-adrenergic Agonist on the Kinetics of Lactated Ringer's Solution During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cyst
Keywords: Pharmacokinetics, kidney;
Receptors, adrenergic;
Fluids, i.v.;
Sympathetic nervous system, esmolol;
Sympathetic nervous system, phenylephrine
Lead sponsor: Sodertalje Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang University
First posted: 2011-09-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* ASA group I
* Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy

Exclusion Criteria:

* ASA group \> I
* Daily medication

Primary outcomes:
measure: Urinary excretion
timeFrame: 3 hours
Secondary outcomes:
measure: Volume kinetics of lactated Ringer´s solution
timeFrame: 3 hours
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Anesthesiology, First Affiliated Hospital, College of Medicine, Zhejiang University
Study officials:
affiliation: Södertälje Hospital, Södertälje, Sweden; Section for Anesthesia, Linköping University, Linköping, Sweden
name: Robert G Hahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/00000542-200411000-00013.
citation: Olsson J, Svensen CH, Hahn RG. The volume kinetics of acetated Ringer's solution during laparoscopic cholecystectomy. Anesth Analg. 2004 Dec;99(6):1854-1860. doi: 10.1213/01.ANE.0000134809.07605.3C.
citation: 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. doi: 10.1016/j.jss.2005.09.012. Epub 2005 Dec 2.
citation: Hahn RG. Volume kinetics for infusion fluids. Anesthesiology. 2010 Aug;113(2):470-81. doi: 10.1097/ALN.0b013e3181dcd88f.