Effects of Adrenergic Drugs on the Fluid Balance During Surgery

NCT ID: NCT01431612

Last Updated: 2011-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Ovarian Cyst

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Esmolol

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

Group Type ACTIVE_COMPARATOR

Esmolol administration

Intervention Type DRUG

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

Phenylephrine

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

Group Type ACTIVE_COMPARATOR

Phenylephrine infusion

Intervention Type DRUG

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

Lactated Ringer´s solution

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

Group Type PLACEBO_COMPARATOR

Lactated Ringer´s solution

Intervention Type DRUG

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

Interventions

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Esmolol administration

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

Intervention Type DRUG

Phenylephrine infusion

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

Intervention Type DRUG

Lactated Ringer´s solution

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

Intervention Type DRUG

Other Intervention Names

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Drug by Qilu Pharmaceutical Co, Shandong, China Drug by Hefeng Pharmaceutical Co, Shanghai, China.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* ASA group \> I
* Daily medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role collaborator

Sodertalje Hospital

OTHER

Sponsor Role lead

Responsible Party

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Robert Hahn

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert G Hahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Södertälje Hospital, Södertälje, Sweden; Section for Anesthesia, Linköping University, Linköping, Sweden

Locations

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

Hangzhou, , China

Site Status

Countries

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China

References

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Vane LA, Prough DS, Kinsky MA, Williams CA, Grady JJ, Kramer GC. Effects of different catecholamines on the dynamics of volume expansion of crystalloid infusion. Anesthesiology. 2004 Nov;101(5):1136-44. doi: 10.1097/00000542-200411000-00013.

Reference Type BACKGROUND
PMID: 15505449 (View on PubMed)

Olsson J, Svensen CH, Hahn RG. The volume kinetics of acetated Ringer's solution during laparoscopic cholecystectomy. Anesth Analg. 2004 Dec;99(6):1854-1860. doi: 10.1213/01.ANE.0000134809.07605.3C.

Reference Type BACKGROUND
PMID: 15562086 (View on PubMed)

Ewaldsson CA, Vane LA, Kramer GC, Hahn RG. Adrenergic drugs alter both the fluid kinetics and the hemodynamic responses to volume expansion in sheep. J Surg Res. 2006 Mar;131(1):7-14. doi: 10.1016/j.jss.2005.09.012. Epub 2005 Dec 2.

Reference Type BACKGROUND
PMID: 16325856 (View on PubMed)

Hahn RG. Volume kinetics for infusion fluids. Anesthesiology. 2010 Aug;113(2):470-81. doi: 10.1097/ALN.0b013e3181dcd88f.

Reference Type BACKGROUND
PMID: 20613481 (View on PubMed)

Other Identifiers

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Esmolol study

Identifier Type: -

Identifier Source: org_study_id

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