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Effects of Adrenergic Drugs on the Fluid Balance During Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431612
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : September 9, 2011
Zhejiang University
Information provided by (Responsible Party):
Robert Hahn, 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.

Condition or disease Intervention/treatment Phase
Ovarian Cyst Drug: Esmolol administration Drug: Phenylephrine infusion Drug: Lactated Ringer´s solution Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: The Effects of ß1-receptor Blockade and α1-adrenergic Agonist on the Kinetics of Lactated Ringer's Solution During Surgery
Study Start Date : November 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Active Comparator: Esmolol
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
50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours
Other Name: Drug by Qilu Pharmaceutical Co, Shandong, China

Active Comparator: Phenylephrine
Intravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours.
Drug: Phenylephrine infusion
0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine
Other Name: Drug by Hefeng Pharmaceutical Co, Shanghai, China.

Placebo Comparator: Lactated Ringer´s solution
10 ml/h lactated Ringer's solution without active drug was infused intravenously over 3 hours.
Drug: Lactated Ringer´s solution
Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug

Primary Outcome Measures :
  1. Urinary excretion [ Time Frame: 3 hours ]
    Urine was collected via an indwelling catheter during 3 hours of surgery

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431612

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Department of Anesthesiology, First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
Sponsors and Collaborators
Sodertalje Hospital
Zhejiang University
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Principal Investigator: Robert G Hahn, MD, PhD Södertälje Hospital, Södertälje, Sweden; Section for Anesthesia, Linköping University, Linköping, Sweden
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Responsible Party: Robert Hahn, Investigator, Sodertalje Hospital Identifier: NCT01431612    
Other Study ID Numbers: Esmolol study
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 2011
Keywords provided by Robert Hahn, Sodertalje Hospital:
Pharmacokinetics, kidney;
Receptors, adrenergic;
Fluids, i.v.;
Sympathetic nervous system, esmolol;
Sympathetic nervous system, phenylephrine
Additional relevant MeSH terms:
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Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists