EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

Active Emergence From General Anesthesia Clinical Trial

Official title:

Electroencephalogram Studies of Intravenous Methylphenidate-Induced Emergence From General Anesthesia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02429076
• Other study ID #: 2015P000566
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: April 8, 2015
• Last updated: August 1, 2017
• Start date: June 2017
• Est. completion date: December 2019

Study information

• Verified date: August 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 36 Years

Eligibility

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.

Related Conditions & MeSH terms

• Active Emergence From General Anesthesia

Intervention

Drug:
• IV methylphenidate
IV methylphenidate will be administered to induce emergence from general anesthesia.
• Placebo
normal saline
• Sevoflurane
Inhaled anesthetic
• Propofol
IV anesthetic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to methlyphenidate administration	The number of minutes from the administration of methylphenidate until subjects respond to verbal commands	minutes to response, expected average is less than 10 minutes