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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Experimental | Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery |
|
| Placebo | Placebo Comparator | 20 mg Placebo (PO) given 2 hours prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicoleta Stoicea, MD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate | Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery 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) |
| FG001 | Placebo | 20 mg Placebo (PO) given 2 hours prior to surgery Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate | Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | minutes | From the moment when isoflurane infusion is stopped until time of extubation |
|
34 days
Continued multi-modal monitoring and vigilance with regard to any suspected adverse effects, including cardiovascular effects will help to fill the informational gap with regards to unknown cardiovascular side effects, emergence delirium incidence and perioperatory awareness.Due to the potential risk of drug related serious side effects, any clinical evidence of a serious adverse event will place the study on clinical hold until a full assessment and decision is made by the responsible parties.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methylphenidate | Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild QTc prolongation | Cardiac disorders | Systematic Assessment | Mild QTc prolongation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicoleta Stoicea | The Ohio State University Wexner Medical Center | 614-293-3559 | nicoleta.stoicea@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 | Dec 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | 20 mg of placebo (PO) will be given 2 hours prior to surgery |
|
|
| 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 |
| BG001 |
| Placebo |
20 mg Placebo (PO) given 2 hours prior to surgery Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
20 mg Placebo (PO) given 2 hours prior to surgery
Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | First 24 Hours Postoperatively |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery |
|
|
|
| 0 |
| 27 |
| 11 |
| 27 |
| 0 |
| 27 |
| EG001 | Placebo | 20 mg Placebo (PO) given 2 hours prior to surgery Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery | 0 | 27 | 11 | 27 | 0 | 27 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |