Sugammadex and Brain Waves

Anaesthesia Clinical Trial

Official title:

The Effect of Sugammadex of EEG-derived Index Values

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142648
• Other study ID #: R09041M
• Secondary ID: 2009-010916-14
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2010
• Last updated: June 10, 2010
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2010
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

According to our experience, electroencephalogram-based indices of anaesthetic state show elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade). This can be due to altered anaesthetic state, or some kind of artefact. In this study, the phenomenon is evaluated in detail.

Description:

Rocuronium-induced neuromuscular blockade is antagonized with sugammadex or neostigmine. BIS, Entropy and the biosignal collected from the Entropy strip are collected on computer. The behaviour of these parameters before, during and after reversal on neuromuscular blockade will be analyzed in detail.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• females giving informed consent

• age range 18-65 years

• elective surgery: gynaecological

• general anaesthesia

• ASA classification 1 or 2

Exclusion Criteria:

• pregnancy

• body mass index > 30

• disease affecting CNS

• overuse of alcohol

• drug abuse

• unability to understand, read or use Finnish language

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia

Intervention

Drug:
• Sugammadex
Sugammadex 200 mg iv, single dose, bolus.
• Neostigmine and glycopyrrolate
Neostigmine 2.5 mg and glycopyrrolate 0,5 mg, iv, single dose, bolus, diluted in 2 ml volume with saline

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The behaviour of depth of anaesthesia indexes (BIS,SE,RE)		30 minutes	No
Secondary	The behaviour of electroencephalography		30 minutes	No