Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01301261

Enrollment

Registered

2011-02-23

Start date

2010-12-31

Completion date

Unknown

Last updated

2012-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified

Keywords

Sugammadex, entropy, bispectral index, blood pressure, heart rate, oxygenation, end-tidal CO2, hemodynamics, general anesthesia

Brief summary

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.

Detailed 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

Interventions

DRUGsugammadex

Sugammadex 2 mg/kg when a two count of train of four appears

DRUGSugammadex 4 mg/kg

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

DRUGSugammadex 16mg/kg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* patients hypertensive * treated with antihypertensive drugs

Design outcomes

Primary

Measure	Time frame
Entropy	every three minutes

Secondary

Measure	Time frame
hemodynamics	every three minutes

Countries

Greece

Contacts

Primary ContactArgyro Fassoulaki, MD, PhD, DEAA

fassoula@aretaieio.uoa.gr+30210 9024530

Backup ContactKonstantinos Chondrogiannis, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026