Surgical Procedure, UnspecifiedNCT01301261
Sugammadex: Effect on the Awareness Monitoring and Hemodynamics
A study testing sugammadex, Sugammadex 4 mg/kg and Sugammadex 16mg/kg in people with Surgical Procedure, Unspecified, run by University of Athens at 1 site in Greece.
Trial summary
Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- sugammadex, Sugammadex 4 mg/kg and Sugammadex 16mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2010to Feb 2013
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients ASA I-III scheduled for elective major surgery
- both sexes
Who cannot join
- patients hypertensive
- treated with antihypertensive drugs
Trial locations and contacts
1 site in 1 country.
Konstantinos Chondrogiannis, MD contact
Greece1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Aretaieio Hospital
Athens, 11528
Argyro Fassoulaki, MD, PhD, DEAA
Konstantinos Chondrogiannis
About this study
Official title: The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker
Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.
Read the detailed description
Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.
Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.
Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- sugammadex, Sugammadex 4 mg/kg, Sugammadex 16mg/kg
- Keywords
- Sugammadex, entropy, bispectral index, blood pressure, heart rate, oxygenation, end-tidal CO2, hemodynamics, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
Sugammadex 2 mg/kg when a two count of train of four appears
Sugammadex 4 mg/kgDrug
Sugammadex 4 mg/kg are given when a posttetanic count 1-3 appears
Sugammadex 16mg/kgDrug
Sugammadex 16 mg/kg three minutes after the injection of cis-atracurium
| Study group | Role | What they receive |
|---|---|---|
| sugammadex 2 mg/kg | Active comparator | 2 mg/kg of sugammadex are given when a response of two counts of train of four are present Receives: Drug: sugammadex |
| 4 mg/kg of sugammadex | Active comparator | 4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears Receives: Drug: Sugammadex 4 mg/kg |
| Sugammadex 16 mg/kg | Active comparator | Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium Receives: Drug: Sugammadex 16mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Entropy
Measured: every three minutes
Secondary outcomes (1)
hemodynamics
Measured: every three minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Argyro Fassoulaki, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301261
- Sponsor's protocol ID
- Σ-150/03-08-10
- Status last verified
- Jun 2012
- First submitted
- 22 Feb 2011
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker
- ClinicalTrials.gov ID
- NCT01301261
- Acronym / sponsor ID
- Σ-150/03-08-10
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- Sugammadex, entropy, bispectral index, blood pressure, heart rate, oxygenation, end-tidal CO2, hemodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2013 (estimated)
- First posted
- 23 Feb 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.
Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.
Detailed description
Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.
Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.
Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sugammadex 2 mg/kg | Active comparator | Drug: sugammadex2 mg/kg of sugammadex are given when a response of two counts of train of four are present |
| 4 mg/kg of sugammadex | Active comparator | Drug: Sugammadex 4 mg/kg4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears |
| Sugammadex 16 mg/kg | Active comparator | Drug: Sugammadex 16mg/kgSugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients ASA I-III scheduled for elective major surgery
- both sexes
Key exclusion criteria (2 listed)
- patients hypertensive
- treated with antihypertensive drugs
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 |
|---|---|---|
| sugammadexSugammadex 2 mg/kg when a two count of train of four appears | Drug | sugammadex 2 mg/kg |
| Sugammadex 4 mg/kgSugammadex 4 mg/kg are given when a posttetanic count 1-3 appears | Drug | 4 mg/kg of sugammadex |
| Sugammadex 16mg/kgSugammadex 16 mg/kg three minutes after the injection of cis-atracurium | Drug | Sugammadex 16 mg/kg |
Primary outcome
Entropy
Time frame: every three minutes
1 secondary outcome
hemodynamics
Time frame: every three minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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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.
Konstantinos Chondrogiannis, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugammadex, Sugammadex 4 mg/kg and Sugammadex 16mg/kg in people with Surgical Procedure, Unspecified, run by University of Athens at 1 site in Greece.
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: status not confirmed, as of the sponsor's last update on 19 Jun 2012. 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 Greece. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Argyro Fassoulaki, MD, PhD, DEAA (+30210 9024530, fassoula@aretaieio.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Entropy (time frame: every three minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2012.