Morbid ObesityPhase 2/3NCT01629394
Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients
A Phase 2/3 study testing Sugammadex and Neostigmine in people with Morbid Obesity and Neuromuscular Blockade, run by University of Patras at 1 site in Greece.
Trial summary
Postoperative residual curarization in the post anaesthesia unit has been associated to complications involving respiratory function and impaired laryngeal and pharyngeal muscles' function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Neuromuscular Blockade
- What is being tested?
- Sugammadex and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2012to Nov 2012
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) >40kg
- Age < 60
- Patients written consent to participate in the study
Who cannot join
- Cardiovascular disease (NYHA>2)
- Patients refusal to participate in the study
- Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
- coexisting neuromuscular disease
- history of allergic reaction to neuromuscular blocking agents
- history of difficult intubation
- creatinine levels > 159lmol/l
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of Patras, Department of Anesthesiology and Critical Care Medicine
Pátrai, Achaia, 26500
Kriton S. Filos, MD PhD, 00302610999341, kritonfilos@yahoo.gr
About this study
Official title: Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Weight Loss Surgery.Use of Acceleromyography Monitoring in Adductor Pollicis and Corrugator Supercilii.
Postoperative residual curarization in the post anaesthesia unit has been associated to complications involving respiratory function and impaired laryngeal and pharyngeal muscles' function. Speed of reversal of neuromuscular blockade after administration of sugammadex versus neostigmine has been studied, but up to date no data are available concerning continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii in morbidly obese patients undergoing weight loss surgery. The investigators' aim in this prospective, double-blinded study was to compare train of four ( TOF ) values, the presence or absence of clinical criteria of postoperative residual curarization , the dose requirements and the side effects of sugammadex and neostigmine for the reversal of rocuronium induced neuromuscular blockade in patients undergoing laparoscopic or open surgery for morbid obesity.
Read the detailed description
Morbidly obese patients [ body mass index (BMI) > 40 kg/m2 ] planned to undergo open or laparoscopic surgery for weight loss will be managed with standardized general anesthesia (intravenous Propofol combined with remifentanil and muscle relaxation induced by rocuronium).
By the end of the surgery, Group A and group E patients will receive sugammadex 2 mg/kg corrected body weight [corrected body weight(CBW)=ideal body weight(IBW) + 40%(real body weight(RBW)-ideal body weight)] when T2 arises in adductor pollicis. Group C and group G will receive neostigmine 50μg/kg corrected body weight when T2 arises in adductor pollicis. Group B and group F patients will receive sugammadex 2 mg/kg ideal body weight when T2 arises in adductor pollicis. Group D and group H patients will receive 50μg/kg neostigmine ideal body weight.
Investigators will proceed in continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii during induction of anaesthesia, surgery, recovery and in the post anaesthesia care unit, recording TOF values. Total consumption of neuromuscular blocking agent, doses of reversal agents and clinical criteria of post operation residual curarization will also be recorded.
- Conditions
- Morbid Obesity, Neuromuscular Blockade
- Being tested
- Sugammadex, Neostigmine
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion(R)
Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
SugammadexDrug
Also called Bridion(R)
Single dose of sugammadex 2 mg/kg ( ideal body weight )
NeostigmineDrug
Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
NeostigmineDrug
Single dose of neostigmine 50 μg/kg ( ideal body weight )
SugammadexDrug
Also called Bridion(R)
Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)]
SugammadexDrug
Also called Bridion(R)
Single dose of sugammadex 2 mg/kg ( ideal body weight )
NeostigmineDrug
Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
NeostigmineDrug
Single dose of neostigmine 50μg/kg ( ideal body weight )
| Study group | Role | What they receive |
|---|---|---|
| Group A: Sugammadex CBW-open | Active comparator | Group A patients will undergo open surgery and will receive sugammadex 2mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] when T2 arises in adductor pollicis. Receives: Drug: Sugammadex |
| Group B: Sugammadex IBW-open | Active comparator | Group B patients will undergo open surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis. Receives: Drug: Sugammadex |
| Group C: Neostigmine CBW-open | Active comparator | Group C patients will undergo open surgery and will receive neostigmine 50μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]when T2 arises in adductor pollicis. Receives: Drug: Neostigmine |
| Group D: Neostigmine-IBW | Active comparator | Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis. Receives: Drug: Neostigmine |
| Group E: Sugammadex CBW-Lap | Active comparator | Group E patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] when T2 arises in adductor pollicis. Receives: Drug: Sugammadex |
| Group F: Sugammadex IBW-Lap | Active comparator | Group F patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis. Receives: Drug: Sugammadex |
| Group G: Neostigmine CBW-Lap | Active comparator | Group C patients will undergo laparoscopic surgery and will receive neostigmine 50μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]when T2 arises in adductor pollicis. Receives: Drug: Neostigmine |
| Group H: Neostigmine IBW-Lap | Active comparator | Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis. Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii
Measured: TOF values for 2.5 h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prokopios Georgiou, University of Patras
- Investigators
- Prokopios S. Georgiou, M.D., Principal investigator, University Hospital of PatrasKriton S. Filos, Professor, Study chair, University of Patras, Dept. of Anaesthesiology and Critical Care MedicineAthena Siampalioti, M.D., Study director, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629394
- Sponsor's protocol ID
- 952/21-3-12
- Status last verified
- Jun 2012
- First submitted
- 1 Apr 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Weight Loss Surgery.Use of Acceleromyography Monitoring in Adductor Pollicis and Corrugator Supercilii.
- ClinicalTrials.gov ID
- NCT01629394
- Acronym / sponsor ID
- 952/21-3-12
- Conditions
- Morbid Obesity, Neuromuscular Blockade
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 27 Jun 2012 (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.
Postoperative residual curarization in the post anaesthesia unit has been associated to complications involving respiratory function and impaired laryngeal and pharyngeal muscles' function. Speed of reversal of neuromuscular blockade after administration of sugammadex versus neostigmine has been studied, but up to date no data are available concerning continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii in morbidly obese patients undergoing weight loss surgery. The investigators' aim in this prospective, double-blinded study was to compare train of four ( TOF ) values, the presence or absence of clinical criteria of postoperative residual curarization , the dose requirements and the side effects of sugammadex and neostigmine for the reversal of rocuronium induced neuromuscular blockade in patients undergoing laparoscopic or open surgery for morbid obesity.
Detailed description
Morbidly obese patients [ body mass index (BMI) > 40 kg/m2 ] planned to undergo open or laparoscopic surgery for weight loss will be managed with standardized general anesthesia (intravenous Propofol combined with remifentanil and muscle relaxation induced by rocuronium).
By the end of the surgery, Group A and group E patients will receive sugammadex 2 mg/kg corrected body weight [corrected body weight(CBW)=ideal body weight(IBW) + 40%(real body weight(RBW)-ideal body weight)] when T2 arises in adductor pollicis. Group C and group G will receive neostigmine 50μg/kg corrected body weight when T2 arises in adductor pollicis. Group B and group F patients will receive sugammadex 2 mg/kg ideal body weight when T2 arises in adductor pollicis. Group D and group H patients will receive 50μg/kg neostigmine ideal body weight.
Investigators will proceed in continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii during induction of anaesthesia, surgery, recovery and in the post anaesthesia care unit, recording TOF values. Total consumption of neuromuscular blocking agent, doses of reversal agents and clinical criteria of post operation residual curarization will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group A: Sugammadex CBW-open | Active comparator | Drug: SugammadexGroup A patients will undergo open surgery and will receive sugammadex 2mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] when T2 arises in adductor pollicis. |
| Group B: Sugammadex IBW-open | Active comparator | Drug: SugammadexGroup B patients will undergo open surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis. |
| Group C: Neostigmine CBW-open | Active comparator | Drug: NeostigmineGroup C patients will undergo open surgery and will receive neostigmine 50μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]when T2 arises in adductor pollicis. |
| Group D: Neostigmine-IBW | Active comparator | Drug: NeostigmineGroup D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis. |
| Group E: Sugammadex CBW-Lap | Active comparator | Drug: SugammadexGroup E patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] when T2 arises in adductor pollicis. |
| Group F: Sugammadex IBW-Lap | Active comparator | Drug: SugammadexGroup F patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis. |
| Group G: Neostigmine CBW-Lap | Active comparator | Drug: NeostigmineGroup C patients will undergo laparoscopic surgery and will receive neostigmine 50μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]when T2 arises in adductor pollicis. |
| Group H: Neostigmine IBW-Lap | Active comparator | Drug: NeostigmineGroup D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) >40kg
- Age < 60
- Patients written consent to participate in the study
Key exclusion criteria (7 listed)
- Cardiovascular disease (NYHA>2)
- Patients refusal to participate in the study
- Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
- coexisting neuromuscular disease
- history of allergic reaction to neuromuscular blocking agents
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 |
|---|---|---|
| SugammadexAlso: Bridion(R)Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] | Drug | Group A: Sugammadex CBW-open |
| SugammadexAlso: Bridion(R)Single dose of sugammadex 2 mg/kg ( ideal body weight ) | Drug | Group B: Sugammadex IBW-open |
| NeostigmineSingle dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] | Drug | Group C: Neostigmine CBW-open |
| NeostigmineSingle dose of neostigmine 50 μg/kg ( ideal body weight ) | Drug | Group D: Neostigmine-IBW |
| SugammadexAlso: Bridion(R)Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] | Drug | Group E: Sugammadex CBW-Lap |
| SugammadexAlso: Bridion(R)Single dose of sugammadex 2 mg/kg ( ideal body weight ) | Drug | Group F: Sugammadex IBW-Lap |
| NeostigmineSingle dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] | Drug | Group G: Neostigmine CBW-Lap |
| NeostigmineSingle dose of neostigmine 50μg/kg ( ideal body weight ) | Drug | Group H: Neostigmine IBW-Lap |
Primary outcome
Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii
Time frame: TOF values for 2.5 h postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
Prokopios S. Georgiou, M.D. principal investigator
University Hospital of Patras
Kriton S. Filos, Professor study chair
University of Patras, Dept. of Anaesthesiology and Critical Care Medicine
Athena Siampalioti, M.D. study director
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sugammadex and Neostigmine in people with Morbid Obesity and Neuromuscular Blockade, run by University of Patras 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 3 inclusion and 7 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 27 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Prokopios Georgiou, MD (00306973440348, prgeorg@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii (time frame: TOF values for 2.5 h postoperatively). 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 27 Jun 2012.