Effects of Adrenergic Drugs on the Fluid Balance During Surgery
|ClinicalTrials.gov Identifier: NCT01431612|
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : September 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cyst||Drug: Esmolol administration Drug: Phenylephrine infusion Drug: Lactated Ringer´s solution||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effects of ß1-receptor Blockade and α1-adrenergic Agonist on the Kinetics of Lactated Ringer's Solution During Surgery|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Active Comparator: Esmolol
50 µg/kg/min of the ß-1-receptor-blocker esmolol (Qilu Pharmaceutical Co, Shandong, China) wss infused intravenously over 3 hours
Drug: Esmolol administration
50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours
Other Name: Drug by Qilu Pharmaceutical Co, Shandong, China
Active Comparator: Phenylephrine
Intravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours.
Drug: Phenylephrine infusion
0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine
Other Name: Drug by Hefeng Pharmaceutical Co, Shanghai, China.
Placebo Comparator: Lactated Ringer´s solution
10 ml/h lactated Ringer's solution without active drug was infused intravenously over 3 hours.
Drug: Lactated Ringer´s solution
Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug
- Urinary excretion [ Time Frame: 3 hours ]Urine was collected via an indwelling catheter during 3 hours of surgery
- Volume kinetics of lactated Ringer´s solution [ Time Frame: 3 hours ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431612
|Department of Anesthesiology, First Affiliated Hospital, College of Medicine, Zhejiang University|
|Principal Investigator:||Robert G Hahn, MD, PhD||Södertälje Hospital, Södertälje, Sweden; Section for Anesthesia, Linköping University, Linköping, Sweden|