General Anesthesia Emergence Induced by Methylphenidate
Condition: Delayed Emergence From Anesthesia
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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) by limited 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.
    

Intervention name(s): Methylphenidate HCl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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); 20 mg of placebo (PO) will be given 2 hours prior to surgery
Other intervention name(s): Concerta; Daytrana; Methylin; Ritalin; Placebo (PO)
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment