Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJune 27, 2012
June 1, 2012
9 months
April 1, 2012
June 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Speed of reversal of neuromuscular blockade after administration of different sugammadex/neostigmine doses to TOF values = 0.9 in adductor pollicis and corrugator supercilii
TOF values for 2.5 h postoperatively
Study Arms (8)
Group A: Sugammadex CBW-open
ACTIVE COMPARATORGroup 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 COMPARATORGroup 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 COMPARATORGroup 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 COMPARATORGroup 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 COMPARATORGroup 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 COMPARATORGroup 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 COMPARATORGroup 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 COMPARATORGroup D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.
Interventions
Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Single dose of neostigmine 50 μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) \>40kg
- Age \< 60
- Patients written consent to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Patras, Department of Anesthesiology and Critical Care Medicine
Pátrai, Achaia, 26500, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prokopios S. Georgiou, M.D.
University Hospital of Patras
- STUDY CHAIR
Kriton S. Filos, Professor
University of Patras, Dept. of Anaesthesiology and Critical Care Medicine
- STUDY DIRECTOR
Athena Siampalioti, M.D.
University Hospital of Patras
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prokopios Georgiou M.D.
Study Record Dates
First Submitted
April 1, 2012
First Posted
June 27, 2012
Study Start
January 1, 2012
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
June 27, 2012
Record last verified: 2012-06