Anesthesia Clinical Trial
Official title:
The Effects of Nondepolarizing Muscle Relaxants During General Anesthesia on Perioperative and Postoperative Bleeding in Pediatric and Adult Patients Undergoing Tonsillectomy
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 7 Years |
Eligibility | Inclusion Criteria: - conventional cold tonsillectomy and curettage adenoidectomy - American Society of Anesthesiologists (ASA) physical status classification system: I, II aged between 3 and 7 years Exclusion Criteria: - Contraindications for general anesthesia, coagulation disorders, anemia,identification of an infection during systemic examinations |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Split | Split |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Split |
Croatia,
Alatas N, San I, Cengiz M, Iynen I, Yetkin A, Korkmaz B, Kar M. A mean red blood cell volume loss in tonsillectomy, adenoidectomy and adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2006 May;70(5):835-41. doi: 10.1016/j.ijporl.2005.09.011. Epub 2005 Oct 21. — View Citation
Apuhan T, Yildirim YS, Aksoy F, Borcin O, Ozturan O. The effects of desflurane and sevoflurane on the peri- and postoperative bleeding of adenotonsillectomy patients. Int J Pediatr Otorhinolaryngol. 2011 Jun;75(6):790-2. doi: 10.1016/j.ijporl.2011.03.008. Epub 2011 Apr 1. — View Citation
Prasad KC, Prasad SC. Assessment of Operative Blood Loss and the Factors Affecting it in Tonsillectomy and Adenotonsillectomy. Indian J Otolaryngol Head Neck Surg. 2011 Oct;63(4):343-8. doi: 10.1007/s12070-011-0268-9. Epub 2011 Jun 3. — View Citation
Sarny S, Ossimitz G, Habermann W, Stammberger H. Hemorrhage following tonsil surgery: a multicenter prospective study. Laryngoscope. 2011 Dec;121(12):2553-60. doi: 10.1002/lary.22347. — View Citation
Urik M, Bartos M, Sikolova S, Jancikova J, Perceova K, Jarkovsky J, Klabusayova E, Stourac P, Jabandziev P. Risk Factors for Postoperative Bleeding after Adenoidectomy. Children (Basel). 2021 Mar 21;8(3):242. doi: 10.3390/children8030242. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative blood loss in milliliters | measurement of blood loss by the gravimetric method (the difference in the mass of surgical gauzes weighed on an analytical scale before and after hemostasis represents the mass of blood lost in the gauzes and swabs; we will convert the obtained number into milliliters by dividing it by 1,055 - specific blood density) , plus the volume of blood in the suction tank | during surgery | |
Primary | Duration of hemostasis | Once the tonsils are snared off, we will measured time required to achieve hemostasis | during surgery | |
Primary | Incidence of primary and secondary postoperative bleeding | Bleeding episodes are classified into primary hemorrhage within the first 24 hours of surgery and secondary hemorrhage after the first 24 hours of surgery. Our study will evaluate incidence of primary and secondary bleeding . | up to 15 days after surgery | |
Secondary | Incidence of operative hemostasis due to postoperative primary and/or secondary hemorrhage | Incidence of postoperative hemorrhage requiring surgical treatment in general anesthesia | up to 15 days after surgery | |
Secondary | The number of consumed gauze and swabs in the rocuronium and non-rocuronium group | To evaluate number of the cotton balls soaked with blood in rocuronium and non-rocuronium group | during surgery | |
Secondary | Arterial blood pressure | Systolic, diastolic and mean arterial blood pressure changes every 5 minutes | during surgery |
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