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Completed

NCT Number: NCT01431612

Effects of Adrenergic Drugs on the Fluid Balance During Surgery

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.

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Key information

Conditions

Ovarian Cyst Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Anesthesiology, First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ASA group > I
  • Daily medication

Treatment and study plan

Esmolol administration

Drug

50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours

Other names: Drug by Qilu Pharmaceutical Co, Shandong, China

Phenylephrine infusion

Drug

0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine

Other names: Drug by Hefeng Pharmaceutical Co, Shanghai, China.

Lactated Ringer´s solution

Drug

Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug

Primary outcomes

  1. Urinary excretion

    Time frame: 3 hours

    Urine was collected via an indwelling catheter during 3 hours of surgery

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sodertalje Hospital

Other

Collaborators

  • Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2011
Registry last updated
Sep 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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