The Effects of ß1-receptor Blockade and α1-adrenergic Agonist on the Kinetics of Lactated Ringer's Solution During Surgery
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Urinary excretion
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA group I
- •Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy
Exclusion Criteria
- •ASA group > I
- •Daily medication
Arms & Interventions
Esmolol
50 µg/kg/min of the ß-1-receptor-blocker esmolol (Qilu Pharmaceutical Co, Shandong, China) wss infused intravenously over 3 hours
Intervention: Esmolol administration (Drug)
Phenylephrine
Intravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours.
Intervention: Phenylephrine infusion (Drug)
Lactated Ringer´s solution
10 ml/h lactated Ringer's solution without active drug was infused intravenously over 3 hours.
Intervention: Lactated Ringer´s solution (Drug)
Outcomes
Primary Outcomes
Urinary excretion
Time Frame: 3 hours
Urine was collected via an indwelling catheter during 3 hours of surgery
Secondary Outcomes
- Volume kinetics of lactated Ringer´s solution(3 hours)
Investigators
Robert Hahn
Investigator
Sodertalje Hospital