General Anesthesia Emergence Induced by Methylphenidate (MPOrtho)

Active Emergence of From Isoflurane General Anesthesia 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.

Study Overview

• Status: Completed
• Conditions: Delayed Emergence From Anesthesia
• Intervention / Treatment: Drug: Methylphenidate HCl; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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; Ritalin; Methylin
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 Names: Placebo (PO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence Time	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.	From the moment when isoflurane infusion is stopped until time of extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Experienced Postoperative Nausea and Vomiting	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)	First 24 Hours Postoperatively
Opioid Dose Escalation Prevention	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).	During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery

Collaborators and Investigators

• Sponsor: Nicoleta Stoicea

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2014
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (ESTIMATE): December 30, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: 2013H0296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO