Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399445
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Measurement of Blood Loss in Adenotonsillectomy During General Anesthesia According to the Application of Nondepolarizing Muscle Relaxants
Sponsor:
University Hospital of Split
Organization:
University Hospital of Split
Study Overview
Official Title:
The Effects of Nondepolarizing Muscle Relaxants During General Anesthesia on Perioperative and Postoperative Bleeding in Pediatric and Adult Patients Undergoing Tonsillectomy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 09 saline solution 4 mlkgh 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 mcgkg Fentanyl 25 mgkg Propofol and 06 mgkg 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 mlkg and a respiratory frequency of 14min will be initiated in both groups Every 5 minutes systolic diastolic and mean arterial pressureMAP will be noticed along with heart rate and oxygen saturation by pulse oximetrySpO2
For the maintenance of anesthesia we will use sevoflurane in 02N20 mixture 5050 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 mgkg 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 poleThe 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
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 09 saline solution 4 mlkgh 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 mcgkg Fentanyl 25 mgkg Propofol and 06 mgkg 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 mlkg and a respiratory frequency of 14min will be initiated in both groups Every 5 minutes systolic diastolic and mean arterial pressureMAP will be noticed along with heart rate and oxygen saturation by pulse oximetrySpO2
For the maintenance of anesthesia we will use sevoflurane in 02N20 mixture 5050 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 mgkg 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 poleThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None