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

Pre-eclampsia Aggravated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972659
• Other study ID #: KOU 2012 KAEK 144
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2013
• Last updated: January 10, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-Eclampsia
• Pre-eclampsia Aggravated

Intervention

Drug:
• placebo
Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
• 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

Locations

Country	Name	City	State
Turkey	Kocaeli University Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOF 0.9 Achieving Time		end of the surgery	Yes
Secondary	Rocuronium Onset Time		during the surgery	Yes
Secondary	Rocuronium Supplementation		during surgery	Yes
Secondary	Postoperative Morphine Consumption		after 12 hour surgery	Yes