Measurement of Blood Loss in Adenotonsillectomy During General Anesthesia According to the Application of Nondepolarizing Muscle Relaxants

NCT06399445 | Recruiting Phase 4

• 1 other identifier: 2181-147/01-06/LJ.Z.-24-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adenotonsillectomy; Tonsillectomy; Intraoperative blood loss; Rocuronium bromide

Outcome Measures

Primary Outcomes (3)

• 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

• Duration of hemostasis

  Once the tonsils are snared off, we will measured time required to achieve hemostasis

  during surgery

• 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 Outcomes (3)

• Incidence of operative hemostasis due to postoperative primary and/or secondary hemorrhage

  up to 15 days after surgery

• The number of consumed gauze and swabs in the rocuronium and non-rocuronium group

  during surgery

• Arterial blood pressure

  during surgery

Study Arms (2)

recurrent adenotonsillitis in the age group of 3 to 7 years old, non-rocuronium group

PLACEBO COMPARATOR

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.

Procedure: conventional cold tonsillectomy and curettage adenoidectomy

recurrent adenotonsillitis in the age group of 3 to 7 years old, rocuronium group

ACTIVE COMPARATOR

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.

Procedure: conventional cold tonsillectomy and curettage adenoidectomy; Drug: Rocuronium Bromide

Interventions

conventional cold tonsillectomy and curettage adenoidectomy PROCEDURE

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.

recurrent adenotonsillitis in the age group of 3 to 7 years old, non-rocuronium group; recurrent adenotonsillitis in the age group of 3 to 7 years old, rocuronium group

Rocuronium Bromide DRUG

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.

Also known as: Drug

recurrent adenotonsillitis in the age group of 3 to 7 years old, rocuronium group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• conventional cold tonsillectomy and curettage adenoidectomy
• American Society of Anesthesiologists (ASA) physical status classification system: I, II aged between 3 and 7 years

You may not qualify if:

• Contraindications for general anesthesia, coagulation disorders, anemia,identification of an infection during systemic examinations

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University Hospital Split

Split, 21000, Croatia

RECRUITING

Related Publications (5)

• 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.

  PMID: 33801025 BACKGROUND

• 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.

  PMID: 16243402 BACKGROUND

• 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.

  PMID: 23024939 BACKGROUND

• 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.

  PMID: 21458867 BACKGROUND

• 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.

  PMID: 22109752 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage

Interventions

Rocuronium; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ines Petrović

  University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia

  PRINCIPAL INVESTIGATOR

• Ivan Vukovic

  University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia

  STUDY CHAIR

• Benjamin Benzon

  University of Split School of Medicine, Split, Croatia

  STUDY CHAIR

Central Study Contacts

Ines Petrović

CONTACT

0919827708; inepetrovi@gmail.com

Ivan Vukovic

CONTACT

+385917357070; ivanvukovic333@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: factorial randomised controlled trial

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: April 18, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 31, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)