Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 5:32 PM
Study NCT ID:
NCT01972659
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2013-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Sponsor:
Kocaeli University
Organization:
Study Overview
Official Title:
Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
* 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: