Pre-eclampsia Aggravated
Conditions
Keywords
sugammadex, rocuronium, magnesium, female
Brief summary
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.
Detailed description
Inclusion criteria: * American Society of Anesthesiologists physical status I or II * 18-60 years of age * undergoing elective gynecological surgery * requiring endotracheal intubation Exclusion criteria: * Patients who had body mass index \> 35 * gastroesophageal reflux * a history of allergy * used medication known to interact with the drugs being used in this trial * who experienced expected or unexpected difficulty during intubation or ventilation * had neuromuscular disease * hepatic or renal insufficiency * pregnant * were American Society of Anesthesiologists III or IV * had a family history of malignant hyperthermia * detection if low or high control plasma magnesium levels
Interventions
DRUGplacebo
Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
DRUGMagnesium Sulphate
Experimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion
DRUGsugammadex
4 mg/kg iv bolus at the end of the surgery
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* female patients * American Society of Anesthesiologists (ASA) physical status I or II * 18-60 years of age who were undergoing elective gynecological surgery * requiring endotracheal intubation were enrolled in this prospective study.
Exclusion criteria
* Patients who had body mass index \> 35 * gastroesophageal reflux * a history of allergy * used medication known to interact with the drugs being used in this trial * who experienced expected or unexpected difficulty during intubation or ventilation * had neuromuscular disease * hepatic or renal insufficiency * were pregnant * had a family history of malignant hyperthermia * detection if low or high control plasma magnesium levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TOF 0.9 Achieving Time | end of the surgery |
Secondary
| Measure | Time frame |
|---|---|
| Rocuronium Onset Time | during the surgery |
| Rocuronium Supplementation | during surgery |
| Postoperative Morphine Consumption | after 12 hour surgery |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| 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 | 37 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | problems realted to acceleromyograph | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | Sugammadex and Placebo | Sugammadex and Magnesium Sulphate | Total |
|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 10.3 | 39.4 years STANDARD_DEVIATION 10.6 | 40.1 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 36 Participants | 37 Participants | 73 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
TOF 0.9 Achieving Time
Time frame: end of the surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex and Placebo | TOF 0.9 Achieving Time | 1.6 minutes | Standard Deviation 0.6 |
| Sugammadex and Magnesium Sulphate | TOF 0.9 Achieving Time | 2.1 minutes | Standard Deviation 0.9 |
Secondary
Postoperative Morphine Consumption
Time frame: after 12 hour surgery
Secondary
Rocuronium Onset Time
Time frame: during the surgery
Secondary
Rocuronium Supplementation
Time frame: during surgery