EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

Phase 1

Withdrawn

• Conditions: Active Emergence From General Anesthesia
• Interventions: Drug: IV methylphenidate; Drug: Placebo; Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT02429076
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The aim of this study is to test the hypothesis that methylphenidate actively induces emergence from propofol and sevoflurane general anesthesia in healthy volunteers.

Detailed Description

Basic science and clinical data suggest that activation of one or more of the brain's arousal pathways is a highly plausible way to induce active emergence from general anesthesia. The investigators have compelling experimental data demonstrating that methylphenidate is highly effective in actively inducing emergence from isoflurane and propofol general anesthesia in rodents. The available literature suggests that IV methylphenidate would be safe to administer to patients recovering from general anesthesia, and that in addition to promoting arousal, it would enhance breathing. Both of these effects would be highly desirable in patients recovering from general anesthesia.

Study Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-04-29
• Study Start: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 18-36 years
2. ASA classification 1 or 2
3. Normal body weight, BMI ≤ 30
4. Non-smoker
5. Right handed
6. No history of taking stimulants

Exclusion Criteria

• In general, patients will be excluded from the study if the state of their chronic health problems gives them an ASA physical status classification of 3 or beyond.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sevoflurane	IV methylphenidate	Subjects in this arm will receive sevoflurane general anesthesia
Propofol	IV methylphenidate	Subjects in this arm will receive propofol general anesthesia
Propofol	Placebo	Subjects in this arm will receive propofol general anesthesia
Sevoflurane	Placebo	Subjects in this arm will receive sevoflurane general anesthesia
Propofol	Propofol	Subjects in this arm will receive propofol general anesthesia
Sevoflurane	Sevoflurane	Subjects in this arm will receive sevoflurane general anesthesia

Primary Outcome Measures

Name	Time	Method
Response to methlyphenidate administration	minutes to response, expected average is less than 10 minutes	The number of minutes from the administration of methylphenidate until subjects respond to verbal commands