Effects of Adrenergic Drugs on the Fluid Balance During Surgery

Phase 1

Completed

• Conditions: Ovarian Cyst
• Interventions: Drug: Esmolol administration; Drug: Phenylephrine infusion; Drug: Lactated Ringer´s solution

• Registration Number: NCT01431612
• Lead Sponsor: Sodertalje Hospital

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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-09
• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-07
• Last Update Submitted: 2011-09-07
• Study First Posted: 2011-09-09
• Last Update Posted: 2011-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• ASA group > I
• Daily medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esmolol	Esmolol administration	50 µg/kg/min of the ß-1-receptor-blocker esmolol (Qilu Pharmaceutical Co, Shandong, China) wss infused intravenously over 3 hours
Phenylephrine	Phenylephrine infusion	Intravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours.
Lactated Ringer´s solution	Lactated Ringer´s solution	10 ml/h lactated Ringer's solution without active drug was infused intravenously over 3 hours.

Primary Outcome Measures

Name	Time	Method
Urinary excretion	3 hours	Urine was collected via an indwelling catheter during 3 hours of surgery

Secondary Outcome Measures

Name	Time	Method
Volume kinetics of lactated Ringer´s solution	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.

Trial Locations

Locations (1)

Department of Anesthesiology, First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China