AnesthesiaPhase 4NCT06399445
Measurement of Blood Loss in Adenotonsillectomy During General Anesthesia According to the Application of Nondepolarizing Muscle Relaxants
A Phase 4 study testing conventional cold tonsillectomy and curettage adenoidectomy and Rocuronium Bromide in people with Anesthesia and Neuromuscular Blockade, run by University Hospital of Split at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Anesthesia, Neuromuscular Blockade, Intraoperative Bleeding
- What is being tested?
- conventional cold tonsillectomy and curettage adenoidectomy and Rocuronium Bromide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 18 Apr 2024to 31 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- conventional cold tonsillectomy and curettage adenoidectomy
- American Society of Anesthesiologists (ASA) physical status classification system: I, II aged between 3 and 7 years
Who cannot join
- Contraindications for general anesthesia, coagulation disorders, anemia,identification of an infection during systemic examinations
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Split
Split, 21000
Ines Petrović, 0919827708, inepetrovi@gmail.com
Vesna Ramljak Ušljebrka
About this study
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.
Read the detailed description
Local clinical ethical committee approval is obtained. Written and oral informed consents of patients and parents of 60 chilldren will be obtained and the study initiated. Only American Society of Anesthesiologists (ASA) class I and II patients between 3 and 7 years of age will be eligible. The indication for surgery will be recurrent tonsillar infection and obstructive sleep apnea.
Totally 60 children aged between 3 and 7 years schedule for adenotonsillectomy will be included in this clinical randomized trial. All patients will be subjected to conventional cold tonsillectomy and curettage adenoidectomy under general anesthesia by the same surgeon.
The children will be monitored (electrodes for ECG, blood pressure cuff and pulse oximeter), intravenous line 22 G inserted and 0.9% saline solution 4 ml/kg/h infused. This procedure will be marked as A0 and will represent the beginning of anesthesia. For the induction of anesthesia, the children will be block randomized into two groups, rocuronium group and non-rocuronium group, each including 30 subjects. The randomisation list will be obtained from R program. In non-rocuronium group, we will perform inhalation induction with sevoflurane for tracheal intubation. In rocuronium group, 1 mcg/kg Fentanyl, 2.5 mg/kg Propofol and 0.6 mg/kg rocuronium bromide (esmeron) will be used for the induction of anesthesia. After 2 min, orotracheal intubation will be performed. Volume-controlled ventilation with a tidal volume of 7 ml/kg and a respiratory frequency of 14/min will be initiated in both groups. Every 5 minutes systolic, diastolic and mean arterial pressure(MAP) will be noticed along with heart rate and oxygen saturation by pulse oximetry(SpO2).
For the maintenance of anesthesia, we will use sevoflurane in 02/N20 mixture 50/50 %. Gas flow will continued until the end of the operation. In rocuronium group at the end of surgery, the neuromuscular blockade will be antagonized with Sugammadex 4 mg/kg, and extubation will be performed.
The time at with operator places the Boyle-Dawies mouth opener will mark start of the operation. The mentioned procedure will be marked as T0.
The time after detachment of the second tonsil will be designated as T1 and will indicate a point when hemostasis begins. Removal of the Boyle-Dawies opener and will be marked as T2.
Before starting the surgery, a good amount of cotton and ribbon gauze will be taken, weighed and sterilized. The suction bottle including the rubber tube will be cleaned and emptied completely before starting the operation. A known quantity of saline (100 ml) will be taken in the bowl and used for intermittent suction to prevent blockage of the suction tube.
During surgery, all the blood lost will be collected in the suction bottle. After adenoidectomy, a length of measured ribbon gauze piece (which will be taken from the measured pad) will be packed in the nasopharynx and left in position. Tonsillectomy will be then performed by dissecting the tonsil from the superior to inferior pole.The tonsillar fauces will be packed with cotton from the measured pad. Sterile surgical gauze, which are used for hemostasis within the operative area, will be weighed using an analytical balance before and after use. The resulting difference will represent the mass of lost blood in gauze and swabs. After ligating the bleeders, the nostrils and nasopharynx will be sucked. Then all the saline taken in the bowl will be sucked into the suction bottle. The suction tube will be raised above the level of the suction bottle to ensure that all the fluid was emptied into the suction bottle.
The sum of the above factors will represent the estimated blood loss in milliliters during adenotonsillectomy.
Postoperative hemoglobin and hematocrit will also be measured. Blood loss will be calculated by taking the average of actual blood loss and estimated blood loss
- Conditions
- Anesthesia, Neuromuscular Blockade, Intraoperative Bleeding, Intraoperative Blood Loss, Post Operative Hemorrhage, Anesthesia Complication
- Being tested
- conventional cold tonsillectomy and curettage adenoidectomy, Rocuronium Bromide
- Keywords
- Adenotonsillectomy, Tonsillectomy, Intraoperative blood loss, Rocuronium bromide
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional cold tonsillectomy and curettage adenoidectomyProcedure or surgery
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.
Rocuronium BromideDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: conventional cold tonsillectomy and curettage adenoidectomy; Drug: Rocuronium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during surgery
Duration of hemostasis
Once the tonsils are snared off, we will measured time required to achieve hemostasis
Measured: 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 .
Measured: up to 15 days after surgery
Secondary outcomes (3)
Incidence of operative hemostasis due to postoperative primary and/or secondary hemorrhage
Incidence of postoperative hemorrhage requiring surgical treatment in general anesthesia
Measured: up to 15 days after surgery
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
Measured: during surgery
Arterial blood pressure
Systolic, diastolic and mean arterial blood pressure changes every 5 minutes
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start18 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- factorial randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Petrović, University Hospital of Split
- Investigators
- Ines Petrović, Principal investigator, University Hospital Split, Department of Anesthesiology and Intensive Care, Split, CroatiaIvan Vukovic, Study chair, University Hospital Split, Department of Anesthesiology and Intensive Care, Split, CroatiaBenjamin Benzon, Study chair, University of Split School of Medicine, Split, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399445
- Sponsor's protocol ID
- 2181-147/01-06/LJ.Z.-24-02
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33801025Alatas 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.
PubMed 16243402Prasad 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.
PubMed 23024939Apuhan 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.
PubMed 21458867Sarny 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.
PubMed 22109752
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nondepolarizing Muscle Relaxants During General Anesthesia on Perioperative and Postoperative Bleeding in Pediatric and Adult Patients Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT06399445
- Acronym / sponsor ID
- 2181-147/01-06/LJ.Z.-24-02
- Conditions
- Anesthesia, Neuromuscular Blockade, Intraoperative Bleeding, Intraoperative Blood Loss, Post Operative Hemorrhage, Anesthesia Complication
- Keywords
- Adenotonsillectomy, Tonsillectomy, Intraoperative blood loss, Rocuronium bromide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Local clinical ethical committee approval is obtained. Written and oral informed consents of patients and parents of 60 chilldren will be obtained and the study initiated. Only American Society of Anesthesiologists (ASA) class I and II patients between 3 and 7 years of age will be eligible. The indication for surgery will be recurrent tonsillar infection and obstructive sleep apnea.
Totally 60 children aged between 3 and 7 years schedule for adenotonsillectomy will be included in this clinical randomized trial. All patients will be subjected to conventional cold tonsillectomy and curettage adenoidectomy under general anesthesia by the same surgeon.
The children will be monitored (electrodes for ECG, blood pressure cuff and pulse oximeter), intravenous line 22 G inserted and 0.9% saline solution 4 ml/kg/h infused. This procedure will be marked as A0 and will represent the beginning of anesthesia. For the induction of anesthesia, the children will be block randomized into two groups, rocuronium group and non-rocuronium group, each including 30 subjects. The randomisation list will be obtained from R program. In non-rocuronium group, we will perform inhalation induction with sevoflurane for tracheal intubation. In rocuronium group, 1 mcg/kg Fentanyl, 2.5 mg/kg Propofol and 0.6 mg/kg rocuronium bromide (esmeron) will be used for the induction of anesthesia. After 2 min, orotracheal intubation will be performed. Volume-controlled ventilation with a tidal volume of 7 ml/kg and a respiratory frequency of 14/min will be initiated in both groups. Every 5 minutes systolic, diastolic and mean arterial pressure(MAP) will be noticed along with heart rate and oxygen saturation by pulse oximetry(SpO2).
For the maintenance of anesthesia, we will use sevoflurane in 02/N20 mixture 50/50 %. Gas flow will continued until the end of the operation. In rocuronium group at the end of surgery, the neuromuscular blockade will be antagonized with Sugammadex 4 mg/kg, and extubation will be performed.
The time at with operator places the Boyle-Dawies mouth opener will mark start of the operation. The mentioned procedure will be marked as T0.
The time after detachment of the second tonsil will be designated as T1 and will indicate a point when hemostasis begins. Removal of the Boyle-Dawies opener and will be marked as T2.
Before starting the surgery, a good amount of cotton and ribbon gauze will be taken, weighed and sterilized. The suction bottle including the rubber tube will be cleaned and emptied completely before starting the operation. A known quantity of saline (100 ml) will be taken in the bowl and used for intermittent suction to prevent blockage of the suction tube.
During surgery, all the blood lost will be collected in the suction bottle. After adenoidectomy, a length of measured ribbon gauze piece (which will be taken from the measured pad) will be packed in the nasopharynx and left in position. Tonsillectomy will be then performed by dissecting the tonsil from the superior to inferior pole.The tonsillar fauces will be packed with cotton from the measured pad. Sterile surgical gauze, which are used for hemostasis within the operative area, will be weighed using an analytical balance before and after use. The resulting difference will represent the mass of lost blood in gauze and swabs. After ligating the bleeders, the nostrils and nasopharynx will be sucked. Then all the saline taken in the bowl will be sucked into the suction bottle. The suction tube will be raised above the level of the suction bottle to ensure that all the fluid was emptied into the suction bottle.
The sum of the above factors will represent the estimated blood loss in milliliters during adenotonsillectomy.
Postoperative hemoglobin and hematocrit will also be measured. Blood loss will be calculated by taking the average of actual blood loss and estimated blood loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- factorial randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| recurrent adenotonsillitis in the age group of 3 to 7 years old, non-rocuronium group | Placebo comparator | Procedure: conventional cold tonsillectomy and curettage adenoidectomyAnesthetic 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. |
| recurrent adenotonsillitis in the age group of 3 to 7 years old, rocuronium group | Active comparator | Procedure: conventional cold tonsillectomy and curettage adenoidectomy, Drug: Rocuronium BromideAnesthetic 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- conventional cold tonsillectomy and curettage adenoidectomy
- American Society of Anesthesiologists (ASA) physical status classification system: I, II aged between 3 and 7 years
Key exclusion criteria (1 listed)
- Contraindications for general anesthesia, coagulation disorders, anemia,identification of an infection during systemic examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional cold tonsillectomy and curettage adenoidectomyAfter 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 or surgery | 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 BromideAlso: DrugAfter 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. | Drug | recurrent adenotonsillitis in the age group of 3 to 7 years old, rocuronium group |
Primary outcome
Intraoperative blood loss in milliliters
Time frame: during surgery
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
Duration of hemostasis
Time frame: during surgery
Once the tonsils are snared off, we will measured time required to achieve hemostasis
Incidence of primary and secondary postoperative bleeding
Time frame: up to 15 days after surgery
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 .
3 secondary outcomes
Incidence of operative hemostasis due to postoperative primary and/or secondary hemorrhage
Time frame: up to 15 days after surgery
The number of consumed gauze and swabs in the rocuronium and non-rocuronium group
Time frame: during surgery
Arterial blood pressure
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 33801025Urik 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.
- Background: PubMed 16243402Alatas 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.
- Background: PubMed 23024939Prasad 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.
- Background: PubMed 21458867Apuhan 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.
- Background: PubMed 22109752Sarny 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Petrović principal investigator
University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
Ivan Vukovic study chair
University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
Benjamin Benzon study chair
University of Split School of Medicine, Split, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing conventional cold tonsillectomy and curettage adenoidectomy and Rocuronium Bromide in people with Anesthesia and Neuromuscular Blockade, run by University Hospital of Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ines Petrović (0919827708, inepetrovi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss in milliliters (time frame: during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06399445, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.