General Anesthesia Emergence Induced by Methylphenidate

Delayed Emergence From Anesthesia Clinical Trial

— MPOrtho  

Official title:

Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327195
• Other study ID #: 2013H0296
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: January 2018

Study information

• Verified date: July 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delayed Emergence From Anesthesia

Intervention

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)
• Placebo
20 mg of placebo (PO) will be given 2 hours prior to surgery

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nicoleta Stoicea

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From the moment when isoflurane infusion is stopped until time of extubation
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)	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).	During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery