Delayed Emergence From Anesthesia
Conditions
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.
Interventions
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)
DRUGPlacebo
20 mg of placebo (PO) will be given 2 hours prior to surgery
Sponsors
Nicoleta Stoicea
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence Time | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Experienced Postoperative Nausea and Vomiting | 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) |
| Opioid Dose Escalation Prevention | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 27 |
| 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 | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Placebo | Total | Methylphenidate |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 54 Participants | 27 Participants |
| Age, Continuous | 36 years | 35 years | 32 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 27 Participants | 54 Participants | 27 Participants |
| Sex: Female, Male Female | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Male | 9 Participants | 19 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 11 / 27 | 11 / 27 |
Outcome results
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.
Time frame: From the moment when isoflurane infusion is stopped until time of extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Methylphenidate | Emergence Time | 9 minutes |
| Placebo | Emergence Time | 9 minutes |
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)
Time frame: First 24 Hours Postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methylphenidate | Number of Participants That Experienced Postoperative Nausea and Vomiting | 5 Participants |
| Placebo | Number of Participants That Experienced Postoperative Nausea and Vomiting | 3 Participants |
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).
Time frame: During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylphenidate | Opioid Dose Escalation Prevention | 1.9 Morphine Milligram Equivalents (MME) | Standard Deviation 4.6 |
| Placebo | Opioid Dose Escalation Prevention | 2.8 Morphine Milligram Equivalents (MME) | Standard Deviation 5.3 |