Trial | NCT01431612  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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.
Study Started
Nov 30
2008
Primary Completion
Oct 31
2010
Study Completion
Oct 31
2010
Last Update
Sep 09
2011
Estimate

Drug Esmolol administration

50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours

  • Other names: Drug by Qilu Pharmaceutical Co, Shandong, China

Drug Phenylephrine infusion

0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine

  • Other names: Drug by Hefeng Pharmaceutical Co, Shanghai, China.

Drug Lactated Ringer´s solution

Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug

Esmolol Active Comparator

50 µg/kg/min of the ß-1-receptor-blocker esmolol (Qilu Pharmaceutical Co, Shandong, China) wss infused intravenously over 3 hours

Phenylephrine Active Comparator

Intravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours.

Lactated Ringer´s solution Placebo Comparator

10 ml/h lactated Ringer's solution without active drug was infused intravenously over 3 hours.

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

ASA group > I
Daily medication
No Results Posted