Columbus, Ohio 43210


Purpose:

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. Multi-center, prospective, randomized, double blind, placebo controlled trial involving 120 subjects with partial and full thickness burn injuries, who are eligible for receiving one of two doses of pregabalin (300mg and 600mg) for pain management


Study summary:

Based on this significant arousal stimulatory effect, the investigators hypothesize that methylphenidate (inhibitor of dopamine and norepinephrine transporters) decreases the emergence time from isoflurane general anesthesia. PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: - To assess the efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) bylimited opioids consumption: PONV verbal response scale on a 0 to 10 verbally elicited scale: 0 (no nausea) to 10 (nausea as bad as it could be) - To assess the efficacy of methylphenidate in preventing opioids dose escalation (fast cognitive improvement with efficient pain control -Postoperative Pain Numeric Rating Scale: O=None; (1-3)=Mild; (4-6)= Moderate; (7-10)=Severe). Study Population: Adult patients at Ohio State University Wexner Medical Center - Sports Medicine, aged between 18-65 years, with an American Society of Anesthesiologists (ASA) physical status of I (normal healthy patient) or II (patients with mild systemic disease; no functional limitation) who are scheduled to undergo hip arthroscopic surgery - same day discharge - under isoflurane general anesthesia. Single-center, prospective, randomized, double-blind, placebo-controlled trial involving 54 subjects scheduled to undergo arthroscopic orthopedic surgery under isoflurane general anesthesia at The Ohio State University Wexner Medical Center (OSUWMC) - University Hospital East. Eligible subjects that provide voluntary and written informed consent will be included in this study.


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)


NCT ID:

NCT02327195


Primary Contact:

Principal Investigator
Nicoleta Stoicea, MD, PhD
The Ohio State University Wexner Medical Center

Nicoleta Stoicea, MD, PhD
Phone: 614.293.0775
Email: nicoleta.stoicea@osumc.edu


Backup Contact:

Email: sergio.bergese@osumc.edu
Sergio D Bergese, MD
Phone: : (614) 293-8487


Location Contact:

Columbus, Ohio 43210
United States

Nicoleta Stoicea, MD, PhD
Phone: 614-293-0775
Email: nicoleta.stoicea@osumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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