SYFce1a9d97bffc4fec906d21ec9f47347cRegistry ID: 2023-506020-81-00|UnknownPhase 2Results
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Secondary identifiers
interventional
N/A
1 country
1
We aim to reduce core temperature by lowering ambient temperature utilizing a climate chamber and administrating meperidine and buspirone to inhibit shivering. We will measure difference in temperature (active drug vs. placebo) at termination.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 28, 2023
Actual (reported)Temperature at termination. The experiment for a participant will be terminated if temperature reaches 35C or active cooling exceeds 3 hours or other reasons (technical problems, terminated by participant). Temperature will be measured at all timepoints. Temperature measurements by Body CAP capsule at all time points will function as backup.
Time from initiation of cooling to termination. Esophageal temperature at all time points. Temperature measurements by Body CAP capsule at all time points will function as backup.
Composite score, resulting in shivering present (Yes/No)
Respiratory rate, end-tidal pCO2, SpO2, blood pressure, heartrate, ECG, RASS, difference between temperature at termination and lowest temperature measured after extrication from cold exposure, thermal discomfort VAS(0-10), pain VAS (0-10), nausea yes/no (if yes: mild, moderate or severe), concentration of normeperidine at presumed maximum outside reference range, capillary blood glucose outside reference range measured 30 min after extrication from cold exposure, skin temperature <8C.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
PETHIDINE HYDROCHLORIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Stesolid 5 mg/ml injeksjonsvæske, emulsjon
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
EMULSION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
PETHIDINE HYDROCHLORIDE
Named ingredient: Pethidine hydrochloride
View registry recordStesolid 5 mg/ml injeksjonsvæske, emulsjon
Named ingredient: Diazepam
View registry recordHelse Bergen HF
Bergen, 5021, Norway
First Submitted
June 28, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Temperature Changes During Induction of General Anesthesia in Pediatric Patients
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