Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients

NCT ID: NCT01972659

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

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

Conditions

Pre-eclampsia Aggravated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: DRUG

Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion

sugammadex

Intervention Type: DRUG

4 mg/kg iv bolus at the end of the surgery

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

Group Type: EXPERIMENTAL

Magnesium Sulphate

Intervention Type: DRUG

Experimental :

50 mg/kg bolus plus 15 mg/kg continuous infusion

sugammadex

Intervention Type: DRUG

4 mg/kg iv bolus at the end of the surgery

Interventions

placebo

Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion

Intervention Type: DRUG

Magnesium Sulphate

Experimental :

50 mg/kg bolus plus 15 mg/kg continuous infusion

Intervention Type: DRUG

sugammadex

4 mg/kg iv bolus at the end of the surgery

Intervention Type: DRUG

Other Intervention Names

%0.9 NaCl; isotonic saline; magnesium; bridion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Zehra Ipek ARSLAN

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zehra I. ARSLAN, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Reanimation

Locations

Kocaeli University Hospital

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KOU 2012 KAEK 144

Identifier Type: -

Identifier Source: org_study_id