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NCT06449157 · ClinicalTrials.gov registry record · NA
Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT06449157: Completed NA study, sponsored by Johns Hopkins University.
NCT06449157 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06449157, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
Children undergoing surgery and anesthesia are often negatively impacted by anxiety and fear in the preoperative period. Routine inhalational anesthetic induction is a unique aspect of pediatric anesthesia. Inhalation inductions are usually initiated with sevoflurane with or without nitrous oxide. While less pungent than other volatile agents, sevoflurane at high concentrations and flows used for inhalation inductions still causes children to often repel from the smell. This can lead to an unpleasant interaction and cause heightened anxiety for any subsequent procedures. Olfactory senses are processed in the hippocampus and amygdala and tied to emotion and memory. Parosmia is the distortion of smell perception which can utilized to the pediatric anesthesiologists advantage. It has been demonstrated that using this phenomenon, the anesthesiologist can induce a better smell for the child leading to improved cooperation during an inhalation induction. However, limitations of this study include lack of randomization, small sample size, and use of a nominal scale of yes or no for face mask acceptance. The investigators identified no other studies to validate this potentially powerful tool to optimize anesthetic induction for pediatric patients. The overall objective of this pilot randomized trial is to determine the feasibility of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia.
Interventions
- OTHER Inhalation induction with parosmia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-10-10 |
| Est. Completion | 2025-08-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06449157
The ClinicalTrials.gov registry entry for NCT06449157 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Inhalation induction with parosmia is the first listed.
NCT06449157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06449157 about?
NCT06449157 is a clinical study titled "Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children". Children undergoing surgery and anesthesia are often negatively impacted by anxiety and fear in the preoperative period. Routine inhalational anesthetic induction is a unique aspect of pediatric anesthesia. Inhalation inductions are usually initiated with sevoflurane with or without nitrous oxide. W...
What is the current status of trial NCT06449157?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2024-10-10. Estimated completion is 2025-08-07.
What interventions are being tested in trial NCT06449157?
The interventions under investigation include: Inhalation induction with parosmia (OTHER).
Who is sponsoring clinical trial NCT06449157?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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