Pharmacokinetics, safety and efficacy of a novel method of sevoflurane delivery

Single centre interventional study of a medical device in adults, to evaluate PHArmacokinetics, Safety and Efficacy of a novel method of Sevoflurane delivery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13763034

Enrollment

Registered

2024-10-18

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Sedation and analgesia in adults Other

Interventions

Single centre interventional study of a medical device. Each participant will undertake three experiments on a single visit: Experiment 1: the dose-response relationship of investigator-delivered in-m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 to 50 years 2. Weight 50 to 100 kg 3. BMI 18 to 30 kg/m² 4. Negative infection screen

Exclusion criteria

Exclusion criteria: 1. Any currently active symptomatic medical condition (ASA 3 or 4) 2. Past medical history or family history of malignant hyperthermia 3. Smoker within the last 12 months 4. Alcohol consumption >14 units per week 5. Known or predicted difficult airway 6. Abnormal physiological observations 7. Pregnancy or possibility thereof 8. Current or recent involvement in any pharmacological research studies 9. Lack of fluency in English

Design outcomes

Primary

Measure	Time frame
1. Sevoflurane flow rate is measured using device data during the test 2. Participant respiratory pressure in the mask is measured using device data during the test 3. Participant button presses are measured using device data during the test 4. Capnography and pulse oximetry are measured using capnography and pulse oximetry devices during the test 5. Sevoflurane concentration in the mask is measured using device data during the test 6. Room levels of sevoflurane are measured using environmental sensors during the test 7. Participant VAS scores are measured using Visual Analog Scale (VAS) during the test 8. Participant RASS scores are measured using Richmond Agitation-Sedation Scale (RASS) during the test 9. EMS stimulation levels are measured using EMS device data during the test 10. Response times to stimuli are measured using reaction time tests during the test 11. Recall is measured using memory stimuli tests at participant discharge at the end of the day	—

Measure

Time frame

1. Sevoflurane flow rate is measured using device data during the test 2. Participant respiratory pressure in the mask is measured using device data during the test 3. Participant button presses are measured using device data during the test 4. Capnography and pulse oximetry are measured using capnography and pulse oximetry devices during the test 5. Sevoflurane concentration in the mask is measured using device data during the test 6. Room levels of sevoflurane are measured using environmental sensors during the test 7. Participant VAS scores are measured using Visual Analog Scale (VAS) during the test 8. Participant RASS scores are measured using Richmond Agitation-Sedation Scale (RASS) during the test 9. EMS stimulation levels are measured using EMS device data during the test 10. Response times to stimuli are measured using reaction time tests during the test 11. Recall is measured using memory stimuli tests at participant discharge at the end of the day

—

Secondary

Measure	Time frame
1. Usability assessments measured using observations during and questionnaire after the investigation to log any difficulties using the device 2. Participant feedback measured using questionnaire on discharge after the investigation	—

Countries

England, United Kingdom

Contacts

Public ContactChris;Andrew Mullington;Miller

;

christopher.mullington@nhs.net;clinicaltrials@intersurgical.co.uk+44 (0)20 3312 1248;+44 (0)1189656300

Outcome results

None listed

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