Clinical Trial: The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy

Brief Summary: This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.

Detailed Summary:

Adenotonsillectomy in children is a short surgical procedure under general anesthesia. The ideal muscle relaxant requires intense neuromuscular block for optimal surgical work and complete recovery of neuromuscular function immediately after the end of the surgical procedure without postoperative morbidity. Rocuronium is an intermediate acting neuromuscular blockade. Reduced-dose rocuronium has been reported to provide optimal anesthetic induction without delayed recovery. The investigators aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.

After Institutional Review Board approval and written informed consent from the parents were obtained, 75 children (aged 3 to 10 years, ASA(The American Society of Anesthesia ) I or II) scheduled for adenotonsillectomy were included. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium 0.15 mg kg-1 (R 0.15 group) or rocuronium 0.3mg kg-1 (R 0.3 group) or saline (S group). After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. The investigators assessed conditions during tracheal intubation as excellent, good or poor, using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs. The investigators added rocuronium 0.3 mg kg-1 when there was more than one poor condition. The investigators recorded the time from discontinuation of sevoflurane to time to extubation.


Sponsor: Korea University Anam Hospital

Current Primary Outcome: Conditions during tracheal intubation [ Time Frame: At the time to tracheal intubation, after mask ventilation for 2 minutes ]

We assessed conditions during tracheal intubation as excellent, good or poor, and additionally using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs.


Original Primary Outcome: Same as current

Current Secondary Outcome: time to extubation [ Time Frame: intraoperatve ]

When surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation.


Original Secondary Outcome: Same as current

Information By: Korea University Anam Hospital

Dates:
Date Received: May 11, 2015
Date Started: July 2015
Date Completion: December 2016
Last Updated: January 26, 2016
Last Verified: January 2016