Measurement of Blood Loss in Adenotonsillectomy During General Anesthesia According to the Application of Nondepolarizing Muscle Relaxants
NCT06399445 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-05-03
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.
Conditions
- Anesthesia
- Neuromuscular Blockade
- Intraoperative Bleeding
- Intraoperative Blood Loss
- Post Operative Hemorrhage
- Anesthesia Complication
Interventions
- PROCEDURE
-
conventional cold tonsillectomy and curettage adenoidectomy
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.
- DRUG
-
Rocuronium Bromide
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.
Sponsors & Collaborators
-
University Hospital of Split
lead OTHER
Principal Investigators
-
Ines Petrović · University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
-
Ivan Vukovic · University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
-
Benjamin Benzon · University of Split School of Medicine, Split, Croatia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 3 Years
- Max Age
- 7 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-18
- Primary Completion
- 2025-06-30
- Completion
- 2025-10-31
Countries
- Croatia
Study Locations
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