Phase 1 N=54 Randomized Quadruple-blind Treatment

General Anesthesia Emergence Induced by Methylphenidate

Delayed Emergence From Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT02327195 ↗

Enrolled (actual)

Serious AEs

40.7%

Results posted

Apr 2022

Primary outcome: Primary: Emergence Time — 9; 9 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Methylphenidate HCl (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nicoleta Stoicea
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Emergence Time	9; 9	—
SECONDARY Number of Participants That Experienced Postoperative Nausea and Vomiting	5; 3	—
SECONDARY Opioid Dose Escalation Prevention	1.9; 2.8	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02327195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.