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
Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.
Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugammadex and placebo | Active Comparator | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery |
|
| sugammadex and magnesium sulphate | Experimental | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| TOF 0.9 Achieving Time | end of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rocuronium Onset Time | during the surgery | |
| Rocuronium Supplementation | during surgery | |
| Postoperative Morphine Consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zehra I. ARSLAN, Asst. Prof. | Anesthesiology and Reanimation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University Hospital | Kocaeli | 41380 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex and Placebo | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery |
| FG001 | Sugammadex and Magnesium Sulphate | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery Magnesium Sulphate: Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex and Placebo | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TOF 0.9 Achieving Time | Posted | Mean | Standard Deviation | minutes | end of the surgery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex and Placebo | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor Dr Z Ipek ARSLAN AYDIN | Kocaeli University Medical Faculty | 00905325011339 | zehraipek48@gmail.com |
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D008278 | Magnesium Sulfate |
| D008274 | Magnesium |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Magnesium Sulphate | Drug | Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion |
|
|
| sugammadex | Drug | 4 mg/kg iv bolus at the end of the surgery |
|
|
| after 12 hour surgery |
| BG001 |
| Sugammadex and Magnesium Sulphate |
sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery Magnesium Sulphate: Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Rocuronium Onset Time | Not Posted | during the surgery |
| Secondary | Rocuronium Supplementation | Not Posted | during surgery |
| Secondary | Postoperative Morphine Consumption | Not Posted | after 12 hour surgery |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Sugammadex and Magnesium Sulphate | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery Magnesium Sulphate: Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion sugammadex: 4 mg/kg iv bolus at the end of the surgery | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D017670 |
| Sodium Compounds |
| D017616 | Magnesium Compounds |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D019565 | Metals, Light |
| D008670 | Metals |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |