Reversal of opioid-induced respiratory depression by ketamine in healthy volunteers

Reversal of opioid-induced respiratory depression (OIRD) by ketamine in healthy volunteers – the ORKA trial - ORKA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002148-17-NL

Enrollment

Registered

2016-06-01

Start date

2016-08-24

Completion date

Unknown

Last updated

2018-03-05

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

Conditions

Respiratory depression MedDRA version: 19.0 Level: LLT Classification code 10069144 Term: Acute respiratory insufficiency System Organ Class: 100000004855 MedDRA version: 19.0 Level: LLT Classification code 10038701 Term: Respiratory insufficiency System Organ Class: 100000004855

Interventions

Trade Name: Ketanest-S Product Name: Ketamin Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the pla

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy male of female volunteers aged 18 and older 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Known or suspected neuromuscular or a (family) history of any neuromuscular disease; - A history of allergic reaction to food or medication including study medication; - Any current or previous medical (including high blood pressure), neurological or psychiatric illness (including a history of anxiety); - Alcohol abuse (> 21 units/week); - Illicit drug use in the past 30 days before inclusion; - Pregnancy or lactation; - Participation in any medical or drug trial in the month prior to the current study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To reverse/prevent opioid-induced respiratory depression;Secondary Objective: None;Primary end point(s): Ventilation;Timepoint(s) of evaluation of this end point: 1-h measurement during administration of ketamine	—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

Netherlands

Contacts

Public ContactAlbert Dahan

LUMC

a.dahan@lumc.nl31715262301

Outcome results

None listed

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