Effects of Adrenergic Drugs on the Fluid Balance During Surgery

Sodertalje Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ovarian Cyst

Treatments: Drug: Phenylephrine infusion; Drug: Lactated Ringer´s solution; Drug: Esmolol administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01431612

Esmolol study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• ASA group > I
• Daily medication

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

Esmolol

Active Comparator group

Description:

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

Treatment:

Drug: Esmolol administration

Phenylephrine

Active Comparator group

Description:

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

Treatment:

Drug: Phenylephrine infusion

Lactated Ringer´s solution

Placebo Comparator group

Description:

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

Treatment:

Drug: Lactated Ringer´s solution