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

NCT01972659 | Completed Phase 4 Results DMC

• 1 other identifier: KOU 2012 KAEK 144
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-eclampsia Aggravated

Keywords

sugammadex; rocuronium; magnesium; female

Outcome Measures

Primary Outcomes (1)

• TOF 0.9 Achieving Time

  end of the surgery

Secondary Outcomes (3)

• Rocuronium Onset Time

  during the surgery

• Rocuronium Supplementation

  during surgery

• Postoperative Morphine Consumption

  after 12 hour surgery

Study Arms (2)

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

Drug: placebo; Drug: sugammadex

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

Drug: Magnesium Sulphate; Drug: sugammadex

Interventions

placebo DRUG

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

Also known as: %0.9 NaCl, isotonic saline

sugammadex and placebo

Magnesium Sulphate DRUG

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

Also known as: magnesium

sugammadex and magnesium sulphate

sugammadex DRUG

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

Also known as: bridion

sugammadex and magnesium sulphate; sugammadex and placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients
• American Society of Anesthesiologists (ASA) physical status I or II
• years of age who were undergoing elective gynecological surgery
• requiring endotracheal intubation were enrolled in this prospective study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Hospital

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sodium Chloride; Magnesium Sulfate; Magnesium; Sugammadex

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Assistant Professor Dr Z Ipek ARSLAN AYDIN
• Organization: Kocaeli University Medical Faculty

zehraipek48@gmail.com

00905325011339

Study Officials

• Zehra I. ARSLAN, Asst. Prof.

  Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 30, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 25, 2014
• Results First Posted: February 25, 2014

Record last verified: 2014-01

Locations

TU (1)