NCT01581450

Brief Summary

Evaluation of the effects of 35%/15%/50% N2O/N2/O2 mixtures on the area of hyperalgesia induced by remifentanil in the CCES (Continuous Cutaneous Electrical Stimulation) model in 20 healthy volunteers. The duration of participation for each volunteer is expected to be around 9 weeks with the performance of 4 experimental session 2 weeks apart. The selection visit will last half a day; each experimental session will last half a day; the study end will last 2 hours maximum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

November 30, 2011

Last Update Submit

September 10, 2025

Conditions

Hyperalgesia

Keywords

Hyperalgesia and pain

Outcome Measures

Primary Outcomes (1)

  • Hyperalgesia

    \- Hyperalgesia will be assessed by using a metal rod,(in unit cm).

    at T0, T10, T25, T40, T55, T70, T95, T110, T125, T140 and T155 minutes at each experimental session which will last half day

Secondary Outcomes (5)

  • transcutaneous oxygen saturation

    From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day

  • respiration rate

    From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day

  • systolic and diastolic blood pressures

    From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day

  • Heart rate

    From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day

  • sedation score

    From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day

Study Arms (2)

Tested drug

EXPERIMENTAL

Remifentanil at 0.1 µg/kg/min Tested drug (N2O 35%): 35%/15%/50% N2O/N2/O2

Drug: Nitrous Oxide

Gas Active control

ACTIVE COMPARATOR

Remifentanil at 0.1 µg/kg/min Gas active control (N2O 50%):50%/50% N2O/O2

Drug: Nitrous Oxide

Interventions

Nitrous OxideDRUG

35%

Tested drug

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian healthy male
  • Able to feel a distinct pin-pick sensation on normal skin
  • Subject willing and able to complete the requirements of this study
  • Written informed consent signed prior to any study related procedures

You may not qualify if:

  • History of any past or current renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine haematological, neurological, psychiatric disease or other disorders
  • Any significant history of allergic disease
  • Acute skin disease, lesions, acute sunburn, extensive tattoos or scars
  • Donation of blood within the previous 3 months
  • participation in any other clinical study within the previous 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Erlangen - Nürnberg

Erlangen, 91054, Germany

Location

University of Erlangen - Nürnberg

Erlangen, Germany

Location

Related Publications (1)

  • Wehrfritz A, Bauer M, Noel N, Ramirez-Gil JF, Ihmsen H, Prottengeier J, Schuttler J, Bessiere B. Evaluation of antihyperalgesic and analgesic effects of 35% nitrous oxide when combined with remifentanil: A randomised phase 1 trial in volunteers. Eur J Anaesthesiol. 2021 Dec 1;38(12):1230-1241. doi: 10.1097/EJA.0000000000001468.

    PMID: 34735395RESULT

MeSH Terms

Conditions

HyperalgesiaPain

Interventions

Nitrous Oxidekalinox

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Andreas WEHRFRITZ, MD

    University of Erlangen-Nürnberg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2011

First Posted

April 20, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

DE(2)