The Effects of Nondepolarizing Muscle Relaxants During General Anesthesia on Perioperative and Postoperative Bleeding in Pediatric and Adult Patients Undergoing Tonsillectomy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Although tonsillectomy is one of the most commonly performed surgeries, a review of literature reveals no articles dealing with the study of intraoperative blood loss in tonsillectomy and adenotonsillectomy according to the use of nondepolarizing muscle relaxants. The primary aim of our trial will be to compare blood loss in the operating theatre and postoperatively in two groups of children having adenotonsillectomy. The trial numbers will be randomised in blocks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 7
Healthy Volunteers: f
View:
• conventional cold tonsillectomy and curettage adenoidectomy
• American Society of Anesthesiologists (ASA) physical status classification system: I, II aged between 3 and 7 years
Locations
Other Locations
Croatia
University Hospital Split
RECRUITING
Split
Contact Information
Primary
Ines Petrović
inepetrovi@gmail.com
0919827708
Backup
Ivan Vukovic
ivanvukovic333@gmail.com
+385917357070
Time Frame
Start Date: 2024-04-18
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 60
Treatments
Placebo_comparator: recurrent adenotonsillitis in the age group of 3 to 7 years old, non-rocuronium group
Anesthetic management: after entering the operating room, the children will be monitored (electrodes for ECG, blood pressure cuff and pulse oximeter). We will use gas mixture of O2/N20 50/50% and concentration of Sevoflurane set between 5% and 6 % with a dose of 6 L/min (1.0 -1.3 MAC) for 10 breaths, then we will set 4 % concentration of Sevoflurane. After loss of consciousness, intravenous line 22 G will be obtained and 0.9 % saline infuse with a dose of 4 ml/kg/hr, Fentanyl 1 mcg/kg iv. and Propofol 2 mg/kg. During stage III of anesthetic depth, we will perform orotracheal intubation.
Active_comparator: recurrent adenotonsillitis in the age group of 3 to 7 years old, rocuronium group
Anesthetic management: after entering the operating room, chlidren will be monitored (electrodes for ECG, blood pressure cuff and pulse oximeter). We will use gas mixture of O2/N20 50/50% and concentration of Sevoflurane set between 5% and 6 % with a dose of 6 L/min (1.0 -1.3 MAC) for 10 breaths. After loss of consciousness, we will turn off Sevoflurane, intravenous line 22 G will be obtained and 0.9 % saline infuse with a dose of 4 ml/kg/hr, 1 mcg/kg Fentanyl, 2.5 mg/kg Propofol and 0.6 mg/kg Rocuronium bromide (esmeron). After 2 min, orotracheal intubation will be performed.
Related Therapeutic Areas
Sponsors
Leads: University Hospital of Split