NCT01431612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
Last Updated

September 9, 2011

Status Verified

September 1, 2011

Enrollment Period

1.9 years

First QC Date

September 6, 2011

Last Update Submit

September 7, 2011

Conditions

Ovarian Cyst

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Urinary excretion

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

    3 hours

Secondary Outcomes (1)

  • Volume kinetics of lactated Ringer´s solution

    3 hours

Study Arms (3)

Esmolol

ACTIVE COMPARATOR

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

Phenylephrine

ACTIVE COMPARATOR

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

Drug: Phenylephrine infusion

Lactated Ringer´s solution

PLACEBO COMPARATOR

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

Drug: Lactated Ringer´s solution

Interventions

Esmolol administrationDRUG

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

Also known as: Drug by Qilu Pharmaceutical Co, Shandong, China
Esmolol
Phenylephrine infusionDRUG

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

Also known as: Drug by Hefeng Pharmaceutical Co, Shanghai, China.
Phenylephrine
Lactated Ringer´s solutionDRUG

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

Lactated Ringer´s solution

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • ASA group \> I
  • Daily medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, China

Location

Related Publications (4)

  • 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.

    PMID: 15505449BACKGROUND

  • 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.

    PMID: 15562086BACKGROUND

  • 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.

    PMID: 16325856BACKGROUND

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

    PMID: 20613481BACKGROUND

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Robert G Hahn, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 6, 2011

First Posted

September 9, 2011

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

September 9, 2011

Record last verified: 2011-09

Locations

CN(1)