Clinical Trial: General Anesthesia Emergence Induced by Methylphenidate

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate

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 Summary:

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, place
Sponsor: Nicoleta Stoicea

Current Primary Outcome: Emergence time [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Postoperative Nausea and Vomiting Prevention [ Time Frame: First 24 Hours Postoperatively ]
    Efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) bylimited 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 [ Time Frame: 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).


Original Secondary Outcome:

  • Postoperative Nausea and Vomiting Prevetion [ Time Frame: First 24 Hours Postoperatively ]
    Efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) bylimited 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 [ Time Frame: 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).


Information By: Ohio State University

Dates:
Date Received: December 16, 2014
Date Started: March 2014
Date Completion: July 2018
Last Updated: January 18, 2017
Last Verified: January 2017