General Anesthesia Emergence Induced by Methylphenidate

Phase 1

Completed

Conditions: Delayed Emergence From Anesthesia

Interventions: Drug: Placebo
Drug: Methylphenidate HCl

Registration Number: NCT02327195

Lead Sponsor: Nicoleta Stoicea

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).