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Effects of Adrenergic Drugs on the Fluid Balance During Surgery

This study has been completed.
Sponsor:
Collaborator:
Zhejiang University
Information provided by (Responsible Party):
Robert Hahn, Sodertalje Hospital
ClinicalTrials.gov Identifier:
NCT01431612
First received: September 6, 2011
Last updated: September 7, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Ovarian Cyst
 Drug: Esmolol administration
Drug: Phenylephrine infusion
Drug: Lactated Ringer´s solution
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:

MedlinePlus related topics: Ovarian Cysts
U.S. FDA Resources

Further study details as provided by Sodertalje Hospital:

Primary Outcome Measures:
  • Urinary excretion [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Urine was collected via an indwelling catheter during 3 hours of surgery


Secondary Outcome Measures:
  • Volume kinetics of lactated Ringer´s solution [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • ASA group > I
  • Daily medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431612

Locations
China
Department of Anesthesiology, First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
Sponsors and Collaborators
Sodertalje Hospital
Zhejiang University
Investigators
Principal Investigator: Robert G Hahn, MD, PhD Södertälje Hospital, Södertälje, Sweden; Section for Anesthesia, Linköping University, Linköping, Sweden
  More Information

Publications:

Responsible Party: Robert Hahn, Investigator, Sodertalje Hospital
ClinicalTrials.gov Identifier: NCT01431612     History of Changes
Other Study ID Numbers: Esmolol study
Study First Received: September 6, 2011
Last Updated: September 7, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sodertalje Hospital:
Pharmacokinetics, kidney;
Receptors, adrenergic;
Fluids, i.v.;
Sympathetic nervous system, esmolol;
Sympathetic nervous system, phenylephrine

Additional relevant MeSH terms:
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Adrenergic Agents
Phenylephrine
Oxymetazoline
Esmolol
Adrenergic Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013