The effect of drugs used to reverse neuromuscular blockade on intra-cranial pressure - Reversal and ICP

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011696-68-GB

Enrollment

Registered

2009-09-11

Start date

2009-10-09

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

intracranial pressure changes following craniotomy MedDRA version: 9.1 Level: LLT Classification code 10050598 Term: Brain operation NOS MedDRA version: 9.1 Level: LLT Classification code 10058952 Term: Brain swelling MedDRA version: 9.1 Level: LLT Classification code 10061019 Term: Brain neoplasm

Interventions

Trade Name: Bridion Pharmaceutical Form: Solution for injection Product Name: neostigmine / glycopyrollate Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective craniotomy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age 80 years. Inability to provide own consent Non-elective surgery Surgery not in the supine position

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether sugammadex (Bridion) or neostigmine methylsulphate have any effect on intracranial pressure following elective neurosurgery;Secondary Objective: To assess whether the effects of sugammadex and neostigmine methylsulphate are different with regards to intracranial pressure;Primary end point(s): Change in intracranial pressure following IMP administration	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026