Quantification of the anesthetic effect of nitrous oxide using intravenous "closed-loop" anesthesia - Lachgas Closed loop

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001677-28-DE

Enrollment

180

Registered

2007-07-02

Start date

2007-11-28

Completion date

Unknown

Last updated

2022-05-30

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

Conditions

This is a study of the anesthetic effect of the IMP, nitrous oxide. In this sense "general anesthesia" can be termed the medical condition under investigation.

Interventions

Trade Name: Medizinisches Lachgas N2O Product Name: Distickstoffmonoxid Pharmaceutical Form: Inhalation gas INN or Proposed INN: NITROUS OXIDE CAS Number: 10024972 Concentration unit: % (V/V) percent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - necessity of a general anesthesia with controlled ventilation - age of consent (18 years) reached - informed consent to study 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: - pregnancy - planned duration of surgery more than 6 hours - psychotropic therapy - allergy to a general anesthetic used or to muscle relaxants - CNS disease - previous general anesthesia in the last month - known anomalies in the blood count

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to quantify the reduction of the propofol consumption when nitrous oxide is used in addition to a propofol-remifentanil anesthetic. Nitrous oxide has been traditionally used as an adjunct to almost all forms of general anesthesia in order to reduce the consumption of the other anesthetic drugs, but it has side effects of its own and is a greenhouse gas. From the literature, it is not clear to what extent the addition of nitrous oxide can actually reduce the consumption of intravenous drugs such as propofol.;Secondary Objective: - To quantify the reduction of remifentanil consumption by nitrous oxide. - To test whether the addition of nitrous oxide to a propofol-remifentanil anesthetic can reduce the recovery time.;Primary end point(s): - consumption of propofol secondary end points: - consumption of remifentanil - recovery time (end of propofol application until extubation) - number of hemodynamic alterations with therapeutic consequences during anesthesia - volume infused and blood units transfused - dose of catecholamines required - percentage of bispectral index in the adequate range of 40-60 - incidence of intraoperative memory formation	—

Measure

Time frame

Main Objective: The main objective of the trial is to quantify the reduction of the propofol consumption when nitrous oxide is used in addition to a propofol-remifentanil anesthetic. Nitrous oxide has been traditionally used as an adjunct to almost all forms of general anesthesia in order to reduce the consumption of the other anesthetic drugs, but it has side effects of its own and is a greenhouse gas. From the literature, it is not clear to what extent the addition of nitrous oxide can actually reduce the consumption of intravenous drugs such as propofol.;Secondary Objective: - To quantify the reduction of remifentanil consumption by nitrous oxide. - To test whether the addition of nitrous oxide to a propofol-remifentanil anesthetic can reduce the recovery time.;Primary end point(s): - consumption of propofol secondary end points: - consumption of remifentanil - recovery time (end of propofol application until extubation) - number of hemodynamic alterations with therapeutic consequences during anesthesia - volume infused and blood units transfused - dose of catecholamines required - percentage of bispectral index in the adequate range of 40-60 - incidence of intraoperative memory formation

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Countries

Belgium, France, Germany

Outcome results

None listed

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