General Anesthesia Emergence Induced by Methylphenidate

NCT02327195 | Completed Phase 1 Results DMC

• 1 other identifier: 2013H0296
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether methylphenidate affects time of emergence from isoflurane general anesthesia. Time to emergence was defined as the time from termination of isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.

Conditions

Delayed Emergence From Anesthesia

Outcome Measures

Primary Outcomes (1)

• Emergence Time

  After stopping isoflurane infusion, when the patient breathes spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.

  From the moment when isoflurane infusion is stopped until time of extubation

Secondary Outcomes (2)

• Number of Participants That Experienced Postoperative Nausea and Vomiting

  First 24 Hours Postoperatively

• Opioid Dose Escalation Prevention

  During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery

Study Arms (2)

Methylphenidate

EXPERIMENTAL

Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery

Drug: Methylphenidate HCl

Placebo

PLACEBO COMPARATOR

20 mg Placebo (PO) given 2 hours prior to surgery

Drug: Placebo

Interventions

Methylphenidate HCl DRUG

Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)

Also known as: Concerta, Daytrana, Methylin, Ritalin

Methylphenidate

Placebo DRUG

20 mg of placebo (PO) will be given 2 hours prior to surgery

Also known as: Placebo (PO)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 65 years of age
• ASA I or II
• Capable and willing to consent
• Participants literate in English language

You may not qualify if:

• ADHD with current use of methylphenidate
• Hypersensitivity to methylphenidate
• ASA III, IV or V
• Patients with severe visual or auditory disorder
• Illiteracy
• Presence of a clinically diagnosed anxiety, agitation, major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
• Tics or Tourette's syndrome
• Glaucoma
• Hypertension, history of atrial arrhythmias (atrial fibrillation, atrial flutter), myocardial infarction
• Taking or have taken within the past 14 days a monoamine oxidase inhibitor or MAOI (Selegiline)
• Subjects who have participated or are currently participating in a clinical trial of an investigational drug within 30 days prior to surgery
• Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study such as history of unstable cardiovascular, pulmonary, renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality (hyperthyroidism, unstable Diabetes type I/II)

Sponsors & Collaborators

• Nicoleta Stoicea: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Nicoleta Stoicea
• Organization: The Ohio State University Wexner Medical Center

nicoleta.stoicea@osumc.edu

614-293-3559

Study Officials

• Nicoleta Stoicea, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist, Adj. Assistant professor

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 30, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 12, 2022
• Results First Posted: April 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)