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Completed

NCT Number: NCT02327195

General Anesthesia Emergence Induced by Methylphenidate

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Other names: Concerta, Daytrana, Methylin, Ritalin

Placebo

Drug

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

Other names: Placebo (PO)

Primary outcomes

  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 outcomes

  1. Number of Participants That Experienced Postoperative Nausea and Vomiting

    Time frame: First 24 Hours Postoperatively

    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)

  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).

Sponsors and collaborators

Lead sponsor

Nicoleta Stoicea

Other

Registry information

Official study title

Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate

Acronym: MPOrtho

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 30, 2014
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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