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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016857-16 | EudraCT Number |
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During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is still some neuromuscular blocking activity left in the patient on awakening from anesthesia. This is called residual curarization and is known to cause postoperative complications such as impairment of respiratory function.
Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It allows for reversing of neuromuscular transmission blocking activity. Until now, all studies with sugammadex were performed in non-obese patients.
Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore it is vital to avoid residual curarization. Sugammadex might be an important factor.
Obese patients have a large total body weight different from ideal body weight. Recent research demonstrated that the dose for the neuromuscular blocking agent rocuronium (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total Body Weight.
At this moment no data is available on the dose-response relationship of sugammadex in morbidly obese patients.
We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal bodyweight, instead of total bodyweight.
Flowchart :
72 participants
Stratification
BMI<50 BMI >50
Randomization Randomization
TBW IBW TBW IBW
2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9
TBW : Total Body Weight IBW : Ideal Body Weight
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI < 50, Total Body Weight (TBW), 2mg/kg | Experimental | Patients with a BMI < 50, who will be dosed according to total body weight. |
|
| BMI < 50, TBW, 4 mg/kg | Experimental | Patients with a BMI < 50, who will be dosed according to total body weight. |
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| BMI < 50, Ideal Body Weight (IBW), 2 mg/kg | Experimental | Patients with a BMI < 50, who will be dosed according to ideal body weight. |
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| BMI < 50, IBW, 4 mg/kg | Experimental | Patients with a BMI < 50, who will be dosed according to ideal body weight. |
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| BMI > 50, TBW, 2mg/kg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex 2 mg/kg | Drug | Patients receive 2 mg/kg Sugammadex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete recovery of muscle relaxation, 30 minutes after end of surgery. | Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care. | 30 minutes after end of surgery. |
| Time to complete recovery of muscle relaxation, 1 hour after the end of surgery. | Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care. | 1hour after end of surgery. |
| Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery. | Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care. | 1hour 30 minutes after end of surgery. |
| Time to complete recovery of muscle relaxation, 2 hours after the end of surgery. | Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care. | 2 hours after end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Need/use of rescue medication at the end of surgery | Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery. | The hours following the end of surgery. |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Jurgen Van Limmen, MD | University Hospital, Ghent | Principal Investigator |
| Luc De Baerdemaeker, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Koen Reyntjens, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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Patients with a BMI > 50, who will be dosed according to total body weight.
|
| BMI > 50, TBW, 4mg/kg | Experimental | Patients with a BMI > 50, who will be dosed according to total body weight. |
|
| BMI >50, IBW, 2 mg/kg | Experimental | Patients with a BMI > 50, who will be dosed according to ideal body weight. |
|
| BMI >50, IBW, 4 mg/kg | Experimental | Patients with a BMI > 50, who will be dosed according to ideal body weight. |
|
| Sugammadex. 4 mg/kg | Drug | Patients receive 4 mg/kg Sugammadex. |
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| Neuromuscular monitoring. | Procedure | Neuromuscular monitoring using a TOF watch SX (Organon). |
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| Clinical evaluation of residual curarization . | Procedure | Every 30 min, during the first 2 hours after the end of the surgery. |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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