Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Surgical Procedure, Unspecified

Treatments: Drug: Sugammadex 16mg/kg; Drug: Sugammadex 4 mg/kg; Drug: sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT01301261

Σ-150/03-08-10

Details and patient eligibility

About

Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.

Full description

Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.

Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.

Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients ASA I-III scheduled for elective major surgery
• both sexes

Exclusion criteria

• patients hypertensive
• treated with antihypertensive drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

sugammadex 2 mg/kg

Active Comparator group

Description:

2 mg/kg of sugammadex are given when a response of two counts of train of four are present

Treatment:

Drug: sugammadex

4 mg/kg of sugammadex

Active Comparator group

Description:

4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears

Treatment:

Drug: Sugammadex 4 mg/kg

Sugammadex 16 mg/kg

Active Comparator group

Description:

Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium

Treatment:

Drug: Sugammadex 16mg/kg