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General Anesthesia Emergence Induced by Methylphenidate (MPOrtho)

Primary Purpose

Delayed Emergence From Anesthesia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate HCl
Placebo
Sponsored by
Nicoleta Stoicea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Emergence From Anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylphenidate

Placebo

Arm Description

Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery

20 mg Placebo (PO) given 2 hours prior to surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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).

Full Information

First Posted
December 16, 2014
Last Updated
July 6, 2022
Sponsor
Nicoleta Stoicea
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1. Study Identification

Unique Protocol Identification Number
NCT02327195
Brief Title
General Anesthesia Emergence Induced by Methylphenidate
Acronym
MPOrtho
Official Title
Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicoleta Stoicea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Emergence From Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 mg Placebo (PO) given 2 hours prior to surgery
Intervention Type
Drug
Intervention Name(s)
Methylphenidate HCl
Other Intervention Name(s)
Concerta, Daytrana, Methylin, Ritalin
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (PO)
Intervention Description
20 mg of placebo (PO) will be given 2 hours prior to surgery
Primary Outcome Measure Information:
Title
Emergence Time
Description
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.
Time Frame
From the moment when isoflurane infusion is stopped until time of extubation
Secondary Outcome Measure Information:
Title
Number of Participants That Experienced Postoperative Nausea and Vomiting
Description
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)
Time Frame
First 24 Hours Postoperatively
Title
Opioid Dose Escalation Prevention
Description
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).
Time Frame
During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicoleta Stoicea, MD, PhD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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General Anesthesia Emergence Induced by Methylphenidate

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