Ovarian CystPhase 1/2NCT01431612
Effects of Adrenergic Drugs on the Fluid Balance During Surgery
A Phase 1/2 study testing Esmolol administration, Phenylephrine infusion and Lactated Ringer´s solution in people with Ovarian Cyst, run by Sodertalje Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Ovarian Cyst
- What is being tested?
- Esmolol administration, Phenylephrine infusion and Lactated Ringer´s solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Oct 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA group I
- Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy
Who cannot join
- ASA group > I
- Daily medication
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou
About this study
Official title: The Effects of ß1-receptor Blockade and α1-adrenergic Agonist on the Kinetics of Lactated Ringer's Solution During Surgery
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.
Read the 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.
- Conditions
- Ovarian Cyst
- Being tested
- Esmolol administration, Phenylephrine infusion, Lactated Ringer´s solution
- Keywords
- Pharmacokinetics, kidney;, Receptors, adrenergic;, Fluids, i.v.;, Sympathetic nervous system, esmolol;, Sympathetic nervous system, phenylephrine
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol administrationDrug
Also called Drug by Qilu Pharmaceutical Co, Shandong, China
50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours
Phenylephrine infusionDrug
Also called Drug by Hefeng Pharmaceutical Co, Shanghai, China.
0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine
Lactated Ringer´s solutionDrug
Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Esmolol administration |
| Phenylephrine | Active comparator | Intravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours. Receives: 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. Receives: Drug: Lactated Ringer´s solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion
Urine was collected via an indwelling catheter during 3 hours of surgery
Measured: 3 hours
Secondary outcomes (1)
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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodertalje Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Responsible party
- Principal investigator, Robert Hahn, Sodertalje Hospital
- Investigators
- Robert G Hahn, MD, PhD, Principal investigator, Södertälje Hospital, Södertälje, Sweden; Section for Anesthesia, Linköping University, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431612
- Sponsor's protocol ID
- Esmolol study
- Status last verified
- Sep 2011
- First submitted
- 6 Sep 2011
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15505449Olsson 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.
PubMed 15562086Ewaldsson 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.
PubMed 16325856Hahn RG. Volume kinetics for infusion fluids. Anesthesiology. 2010 Aug;113(2):470-81. doi: 10.1097/ALN.0b013e3181dcd88f.
PubMed 20613481
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of ß1-receptor Blockade and α1-adrenergic Agonist on the Kinetics of Lactated Ringer's Solution During Surgery
- ClinicalTrials.gov ID
- NCT01431612
- Acronym / sponsor ID
- Esmolol study
- Conditions
- Ovarian Cyst
- Keywords
- Pharmacokinetics, kidney;, Receptors, adrenergic;, Fluids, i.v.;, Sympathetic nervous system, esmolol;, Sympathetic nervous system, phenylephrine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sodertalje HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esmolol | Active comparator | Drug: Esmolol administration50 µg/kg/min of the ß-1-receptor-blocker esmolol (Qilu Pharmaceutical Co, Shandong, China) wss infused intravenously over 3 hours |
| Phenylephrine | Active comparator | Drug: Phenylephrine infusionIntravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours. |
| Lactated Ringer´s solution | Placebo comparator | Drug: Lactated Ringer´s solution10 ml/h lactated Ringer's solution without active drug was infused intravenously over 3 hours. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA group I
- Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy
Key exclusion criteria (2 listed)
- ASA group > I
- Daily medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esmolol administrationAlso: Drug by Qilu Pharmaceutical Co, Shandong, China50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours | Drug | Esmolol |
| Phenylephrine infusionAlso: Drug by Hefeng Pharmaceutical Co, Shanghai, China.0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine | Drug | Phenylephrine |
| Lactated Ringer´s solutionIntravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug | Drug | Lactated Ringer´s solution |
Primary outcome
Urinary excretion
Time frame: 3 hours
Urine was collected via an indwelling catheter during 3 hours of surgery
1 secondary outcome
Volume kinetics of lactated Ringer´s solution
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
- Background: PubMed 15505449Vane 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.
- Background: PubMed 15562086Olsson 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.
- Background: PubMed 16325856Ewaldsson 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.
- Background: PubMed 20613481Hahn RG. Volume kinetics for infusion fluids. Anesthesiology. 2010 Aug;113(2):470-81. doi: 10.1097/ALN.0b013e3181dcd88f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Hahn, MD, PhD principal investigator
Södertälje Hospital, Södertälje, Sweden; Section for Anesthesia, Linköping University, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Esmolol administration, Phenylephrine infusion and Lactated Ringer´s solution in people with Ovarian Cyst, run by Sodertalje Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary excretion (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01431612, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.