Remifentanil in Children With Obstructive Sleep Apnea (ROSA)

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Remifentanil Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03958396

201504056

Details and patient eligibility

About

This investigation tested the hypothesis that children with obstructive sleep apnea have an increased pharmacodynamic sensitivity to the miotic and respiratory depressant effects of the prototypic μ-opioid agonist remifentanil.

Enrollment: 30 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

OSA Group:

Inclusion Criteria:

• 8-14 years old
• ASA physical status 1 or 2
• undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea

Exclusion Criteria:

• Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)

Control (Non-OSA) Group:

Inclusion Criteria:

• 8-14 years old
• ASA physical status 1 or 2
• no known obstructive sleep apnea presenting for any procedure requiring general anesthtic

Exclusion Criteria:

• Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

OSA Group

Active Comparator group

Description:

a) Children 8-14 years old, b) ASA physical status 1or 2, c) undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea

Treatment:

Drug: Remifentanil Infusion

Control (non-OSA) Group

Active Comparator group

Description:

a) Children 8-14 years old, b) ASA physical status 1or 2, c) no known obstructive sleep apnea presenting for any procedure requiring general anesthetic

Treatment:

Drug: Remifentanil Infusion