Clinical Trials Directory

Trials / Completed

CompletedNCT06449157

Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
5 Years – 13 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERInhalation induction with parosmiaThe experimental group will then be told that the patient's favorite smell will be put into the face mask via the "magical machine". The patient will be asked to take a deep breath thinking about that smell and then introduce sevoflurane. The patient will be asked if the chosen flavor is smelled and their response will be noted.

Timeline

Start date
2024-10-10
Primary completion
2025-08-07
Completion
2025-08-07
First posted
2024-06-07
Last updated
2025-08-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06449157. Inclusion in this directory is not an endorsement.