Effects of Adrenergic Drugs on the Fluid Balance During Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Ovarian Cyst

Intervention / Treatment
-----------------
* Drug: Esmolol administration
* Drug: Phenylephrine infusion
* Drug: Lactated Ringer´s solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA group I Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy Exclusion Criteria: ASA group > I Daily medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Esmolol<br>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<br>* 50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours<br>* Other names: Drug by Qilu Pharmaceutical Co, Shandong, China;|
| Active Comparator: Phenylephrine<br>Intravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours. | Drug: Phenylephrine infusion<br>* 0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine<br>* Other names: Drug by Hefeng Pharmaceutical Co, Shanghai, China.;|
| Placebo Comparator: Lactated Ringer´s solution<br>10 ml/h lactated Ringer's solution without active drug was infused intravenously over 3 hours. | Drug: Lactated Ringer´s solution<br>* Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary excretion | Urine was collected via an indwelling catheter during 3 hours of surgery | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, kidney;, Receptors, adrenergic;, Fluids, i.v.;, Sympathetic nervous system, esmolol;, Sympathetic nervous system, phenylephrine