Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289829
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-07
Brief Title:
The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Dose Finding Study of Remifentanil for Laryngeal Mask Airway Insertion During Induction Using Remimazolam
Status:
RECRUITING
Status Verified Date:
2024-02
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:
The laryngeal mask airway LMA is an airway maintenance device that is easy to insert and has the advantage of causing less sore throat and autonomic nervous system stimulation To appropriately insert the LMA an adequate depth of anesthesia is essential Various drugs have been studied for inducing anesthesia to achieve the appropriate depth for LMA insertion and the newly developed benzodiazepine remimazolam is gaining attention as one of them Remimazolam has rapid onset and recovery times hemodynamic stability and is often co-administered with opioids like remifentanil for more effective LMA insertion This study aims to find the optimal dose of remifentanil for the proper insertion of the Ambu Auragain one of the recently developed LMAs during induction of anesthesia using remimazolam and the Biased-Coin Up-and-Down method will be used for this purpose Starting with an initial concentration of remifentanil of 30 μgmL the success or failure of LMA insertion will determine the dosage for the next subject Data will be collected from a total of 60 patients and subsequent analysis will be conducted
Detailed Description:
1Screening Method
1 Subject screening is conducted based on the results of general preoperative tests including checking the patients medical and medication history routine blood tests general chemistry and coagulation tests electrocardiogram ECG chest X-ray etc
2 Subjects are selected from adult patients undergoing elective surgery under general anesthesia using the LMA within 3 hours
3 Patients are visited the day before the surgery Information about the study is provided and patients are allowed sufficient time for deciding participation until arriving at the operating room Informed consent for the participation is achieved on the morning of surgery
2Research Method
1 Monitoring devices including electrocardiogram non-invasive blood pressure monitor pulse oximeter and SedLine brain function monitor Masimo Irvine CA are applied for patient monitoring according to standard care
2 Proper insertion of the intravenous catheter in the patient is confirmed The intravenous line is connected to remifentanil and remimazolam diluted to concentrations of 20μgmL and 1mgmL respectively using syringe pumps
3100 oxygen is administered at 6Lmin for 3 minutes for preoxygenation 4Continuous infusion of remifentanil is started using Target-Controlled Infusion TCI with the Minto model adjusting the effect-site concentration based on the biased-coin up-and-down method The initial concentration for the first patient is 30μgmL Subsequent doses are determined based on the success or failure of the previous subjects LMA insertion 03mgkg of remimazolam is simultaneously administered over approximately 10-20 seconds
5100 oxygen is supplied through a facemask and manual ventilation is performed if necessary When the desired effect-site concentration of remifentanil is confirmed 120 seconds after remimazolam administration LMA is inserted The LMA used for the procedure is AmbuAuraGainTM Ambu AS Ballerup Denmark The size of the LMA is selected according to the manufacturers guide and lubricating jelly is applied on the LMA before the insertion
6If the LMA is determined to obstruct the airway or be malpositioned it is removedand mask ventilation is reengaged The effect-site concentration of remifentanil is increased by 03μgmL and one minute later the LMA is inserted for the second time using the same procedure If the insertion proves unsuccessful despite three attempts following the same approach tracheal intubation is performed
7Data are collected during LMA insertion and maintenance Continuous infusion of remimazolam and remifentanil is conducted to maintain PSI score in the range of 25-50 during the surgery Infusion of the anesthetic agents are stopped when the surgery is finished The LMA is removed after spontaneous breathing is confirmed and the patient is transferred to the recovery room
1 Subject screening is conducted based on the results of general preoperative tests including checking the patients medical and medication history routine blood tests general chemistry and coagulation tests electrocardiogram ECG chest X-ray etc
2 Subjects are selected from adult patients undergoing elective surgery under general anesthesia using the LMA within 3 hours
3 Patients are visited the day before the surgery Information about the study is provided and patients are allowed sufficient time for deciding participation until arriving at the operating room Informed consent for the participation is achieved on the morning of surgery
2Research Method
1 Monitoring devices including electrocardiogram non-invasive blood pressure monitor pulse oximeter and SedLine brain function monitor Masimo Irvine CA are applied for patient monitoring according to standard care
2 Proper insertion of the intravenous catheter in the patient is confirmed The intravenous line is connected to remifentanil and remimazolam diluted to concentrations of 20μgmL and 1mgmL respectively using syringe pumps
3100 oxygen is administered at 6Lmin for 3 minutes for preoxygenation 4Continuous infusion of remifentanil is started using Target-Controlled Infusion TCI with the Minto model adjusting the effect-site concentration based on the biased-coin up-and-down method The initial concentration for the first patient is 30μgmL Subsequent doses are determined based on the success or failure of the previous subjects LMA insertion 03mgkg of remimazolam is simultaneously administered over approximately 10-20 seconds
5100 oxygen is supplied through a facemask and manual ventilation is performed if necessary When the desired effect-site concentration of remifentanil is confirmed 120 seconds after remimazolam administration LMA is inserted The LMA used for the procedure is AmbuAuraGainTM Ambu AS Ballerup Denmark The size of the LMA is selected according to the manufacturers guide and lubricating jelly is applied on the LMA before the insertion
6If the LMA is determined to obstruct the airway or be malpositioned it is removedand mask ventilation is reengaged The effect-site concentration of remifentanil is increased by 03μgmL and one minute later the LMA is inserted for the second time using the same procedure If the insertion proves unsuccessful despite three attempts following the same approach tracheal intubation is performed
7Data are collected during LMA insertion and maintenance Continuous infusion of remimazolam and remifentanil is conducted to maintain PSI score in the range of 25-50 during the surgery Infusion of the anesthetic agents are stopped when the surgery is finished The LMA is removed after spontaneous breathing is confirmed and the patient is transferred to the recovery room
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