Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prokopios Georgiou, MD | Contact | 00306973440348 | prgeorg@yahoo.gr | |
| Kriton S. Filos, MD PhD | Contact | 00302610999341 | kritonfilos@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| Prokopios S. Georgiou, M.D. | University Hospital of Patras | Principal Investigator |
| Kriton S. Filos, Professor | University of Patras, Dept. of Anaesthesiology and Critical Care Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Patras, Department of Anesthesiology and Critical Care Medicine | Recruiting | Pátrai | Achaia | 26500 | Greece |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
|
| 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. |
|
|
| Sugammadex | Drug | Single dose of sugammadex 2 mg/kg ( ideal body weight ) |
|
|
| Neostigmine | Drug | Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] |
|
| Neostigmine | Drug | Single dose of neostigmine 50 μg/kg ( ideal body weight ) |
|
| Sugammadex | Drug | Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)] |
|
|
| Sugammadex | Drug | Single dose of sugammadex 2 mg/kg ( ideal body weight ) |
|
|
| Neostigmine | Drug | Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)] |
|
| Neostigmine | Drug | Single dose of neostigmine 50μg/kg ( ideal body weight ) |
|
| Athena Siampalioti, M.D. | University Hospital of Patras | Study Director |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
Not provided
Not provided