Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841316
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-09
First Post:
2023-04-22
Brief Title:
The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official Title:
The ED95 Dose Determined by Classical Train-of-four Ratio of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
In the European Society of Anaesthesiology and Intensive Care ESAIC guideline on the use of neuromuscular blockers published in 2023 it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade and that neostigmine could be used to reverse superficial neuromuscular block expressed as Train-of-Four Ratio TOFR 04 and above to TOFR 09 Therefore it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block
This study is planned with 2 stages In the first phase of the study the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block PTC 1 to 3 to superficial neuromuscular block TOFR 04 in 95 of patients in 5 minutes following administration
This study is planned with 2 stages In the first phase of the study the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block PTC 1 to 3 to superficial neuromuscular block TOFR 04 in 95 of patients in 5 minutes following administration
Detailed Description:
Laparoscopic surgery also known as minimally invasive surgery is a type of surgical procedure which allows a surgeon to access the inside of the abdomen and pelvis without having to make large incisions in the skin As the administration of deep neuromuscular block has been shown to improve surgical conditions in laparoscopic abdominal surgery patients are usually kept under deep neuromuscular block using either intermittent bolus or continous infusion of neuromuscular blocking drugs such as rocuronium during the surgical procedure 1 Due to small incisions of fascia and skin the duration between the completion of intra-abdominal surgical manipulation in which the patient is usually under rocuronium-induced deep neuromuscular block RIDeNB and the end of skin sutures in which the patient should be closed to fully recover from RIDeNB is often short However the time interval required for reversing RIDeNB may be quite longer if spontaneous neuromuscular recovery is allowed Therefore sugammadex of 4 mgkg is usually recommended to shorten the duration of RIDeNB reversal 2
The incidence of an unplanned re-intubation which occurs shortly after a failed extubation is approximately 004-009 34 Although the incidence seems quite low it may be a life threatening adverse event In case of unplanned re-intubation after the administration of 4 mgkg sugammadex to reverse RIDeNB the anesthesiologist may choose to give a non-steroidal neuromuscular blocker or 12 mgkg of a high dose of rocuronium With re-administration of 12 mgkg rocuronium up to 30 minutes after sugammadex administration the onset of neuromuscular blockade again may be prolonged to approximately 4 minutes and also the duration of neuromuscular blockade may be shortened to approximately 15 minutes Due to the possibility of re-intubation after every single extubation the lower the dose of sugammadex administered during the recovery phase of RIDeNM the less the need for the dose of rocuronium to be applied for the next intubation attempt or better re-intubation conditions will be provided even if the same dose is applied To lower the standard reversal dose of sugammadex it is assumed that gradual recovery can be achieved with the combination of sugammadex and neostigmine to achieve a complete neuromuscular recovery with an effective reliable and lower cost manner
In the ESAIC guideline on the use of neuromuscular blockers published in 2023 it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade and that neostigmine could be used to reverse superficial neuromuscular block expressed as TOFR 04 and above to TOFR 09 5 Therefore it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block
This study is planned with 2 stages In the first phase of the study the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block PTC 1 to 3 to superficial neuromuscular block TOFR 04 in 95 of patients in 5 minutes following administration
The incidence of an unplanned re-intubation which occurs shortly after a failed extubation is approximately 004-009 34 Although the incidence seems quite low it may be a life threatening adverse event In case of unplanned re-intubation after the administration of 4 mgkg sugammadex to reverse RIDeNB the anesthesiologist may choose to give a non-steroidal neuromuscular blocker or 12 mgkg of a high dose of rocuronium With re-administration of 12 mgkg rocuronium up to 30 minutes after sugammadex administration the onset of neuromuscular blockade again may be prolonged to approximately 4 minutes and also the duration of neuromuscular blockade may be shortened to approximately 15 minutes Due to the possibility of re-intubation after every single extubation the lower the dose of sugammadex administered during the recovery phase of RIDeNM the less the need for the dose of rocuronium to be applied for the next intubation attempt or better re-intubation conditions will be provided even if the same dose is applied To lower the standard reversal dose of sugammadex it is assumed that gradual recovery can be achieved with the combination of sugammadex and neostigmine to achieve a complete neuromuscular recovery with an effective reliable and lower cost manner
In the ESAIC guideline on the use of neuromuscular blockers published in 2023 it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade and that neostigmine could be used to reverse superficial neuromuscular block expressed as TOFR 04 and above to TOFR 09 5 Therefore it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block
This study is planned with 2 stages In the first phase of the study the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block PTC 1 to 3 to superficial neuromuscular block TOFR 04 in 95 of patients in 5 minutes following administration
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