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Trial record 29 of 439 for:    Methylphenidate

General Anesthesia Emergence Induced by Methylphenidate (MPOrtho)

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ClinicalTrials.gov Identifier: NCT02327195
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Nicoleta Stoicea, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Delayed Emergence From Anesthesia Drug: Methylphenidate HCl Drug: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate
Actual Study Start Date : May 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate
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
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)
Other Names:
  • Concerta
  • Daytrana
  • Methylin
  • Ritalin

Placebo Comparator: Placebo
20 mg Placebo (PO) given 2 hours prior to surgery
Drug: Placebo
20 mg of placebo (PO) will be given 2 hours prior to surgery
Other Name: Placebo (PO)




Primary Outcome Measures :
  1. Emergence time [ Time Frame: From the moment when isoflurane infusion is stopped until time of extubation ]
    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.


Secondary Outcome Measures :
  1. Postoperative Nausea and Vomiting Prevention [ Time Frame: First 24 Hours Postoperatively ]
    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)

  2. Opioid Dose Escalation Prevention [ Time Frame: During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327195


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Nicoleta Stoicea
Investigators
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Principal Investigator: Nicoleta Stoicea, MD, PhD The Ohio State University Wexner Medical Center

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Responsible Party: Nicoleta Stoicea, Research Scientist, Adj. Assistant professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02327195     History of Changes
Other Study ID Numbers: 2013H0296
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Methylphenidate
Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents