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Effects of Adrenergic Drugs on the Fluid Balance During Surgery

Primary Purpose

Ovarian Cyst

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Esmolol administration

Phenylephrine infusion

Lactated Ringer´s solution

About this trial

This is an interventional supportive care trial for Ovarian Cyst focused on measuring Pharmacokinetics, kidney;, Receptors, adrenergic;, Fluids, i.v.;, Sympathetic nervous system, esmolol;, Sympathetic nervous system, phenylephrine

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

ASA group > I
Daily medication

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Esmolol

Phenylephrine

Lactated Ringer´s solution

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Urinary excretion

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

Secondary Outcome Measures

Volume kinetics of lactated Ringer´s solution

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.

Full Information

NCT ID

NCT01431612

First Posted

September 6, 2011

Last Updated

September 7, 2011

Sponsor

Sodertalje Hospital

Collaborators

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT01431612

Brief Title

Effects of Adrenergic Drugs on the Fluid Balance During Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sodertalje Hospital

Collaborators

Zhejiang University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cyst

Keywords

Pharmacokinetics, kidney;, Receptors, adrenergic;, Fluids, i.v.;, Sympathetic nervous system, esmolol;, Sympathetic nervous system, phenylephrine

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Esmolol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Phenylephrine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Lactated Ringer´s solution

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Esmolol administration

Other Intervention Name(s)

Drug by Qilu Pharmaceutical Co, Shandong, China

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Phenylephrine infusion

Other Intervention Name(s)

Drug by Hefeng Pharmaceutical Co, Shanghai, China.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lactated Ringer´s solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Urinary excretion

Description

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

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

Volume kinetics of lactated Ringer´s solution

Description

Time Frame

3 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA group I Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy Exclusion Criteria: ASA group > I Daily medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert G Hahn, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hangzhou

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

15505449

Citation

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.

Results Reference

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PubMed Identifier

15562086

Citation

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.

Results Reference

background

PubMed Identifier

16325856

Citation

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.

Results Reference

background

PubMed Identifier

20613481

Citation

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

Results Reference

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Effects of Adrenergic Drugs on the Fluid Balance During Surgery

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