Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275542
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-10
First Post:
2024-02-06
Brief Title:
Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment
Sponsor:
University of Surabaya
Organization:
University of Surabaya
Study Overview
Official Title:
Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criterion Without TOF Monitoring Equipment
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
Patients undergoing general anesthesia will have an endotracheal tube inserted Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring
Detailed Description:
The availability of Train-of-Four TOF monitoring devices is not yet widespread in some clinical practices Practitioners are also often unaware of the high incidence of residual paralysis and the associated risks in their daily practice However residual paralysis increases the occurrence of airway obstruction hypoxemia and postoperative pulmonary complications Therefore clinical parameters for extubation criteria must ensure the absence of residual paralysis
Administering oxygen in the ambient air can identify hypoventilation conditions Therefore patients who can maintain oxygen saturation levels 95 can be considered not experiencing hypoventilation The author aims to validate ventilation adequacy as an additional clinical parameter for extubation criteria without TOF monitoring to ensure the absence of residual paralysis in the recovery room
This study is planned using a randomized controlled trial method with observer blinding The study consists of 3 comparisons based on the type of volatile anesthetic gas agent and neuromuscular blockade agent This research will involve 240 subjects aged 18-60 years undergoing elective surgery under intubation general anesthesia Subjects will be divided into two parallel treatment groups randomly stratified by the type of surgery to observe the incidence rate of residual paralysis in the recovery room Group A will receive extubation strategy without additional oxygen supplementation while Group B will use extubation strategy with quantitative TOF monitoring
Group A will receive optimal reversal strategy using neostigmine based on clinical criteria such as tidal volume adequacy and the time of last administration of the neuromuscular blockade agent Then patients will be assessed 15 minutes after reversal for the ability to maintain oxygen saturation levels 95 without oxygen supplementation If they meet these criteria patients will then be extubated Group B will receive optimal reversal strategy using neostigmine based on TOF values If the measured TOF value is 090 patients can be extubated while awake Upon arrival in the recovery room the TOF values of both groups will be measured and compared as the outcome of this study
The results of this study are expected to provide recommendations for extubation strategies based on clinical parameters to clinicians with limited access to TOF monitoring devices With the implementation of this change in extubation strategy unexpected post-anesthesia events may be reduced
Administering oxygen in the ambient air can identify hypoventilation conditions Therefore patients who can maintain oxygen saturation levels 95 can be considered not experiencing hypoventilation The author aims to validate ventilation adequacy as an additional clinical parameter for extubation criteria without TOF monitoring to ensure the absence of residual paralysis in the recovery room
This study is planned using a randomized controlled trial method with observer blinding The study consists of 3 comparisons based on the type of volatile anesthetic gas agent and neuromuscular blockade agent This research will involve 240 subjects aged 18-60 years undergoing elective surgery under intubation general anesthesia Subjects will be divided into two parallel treatment groups randomly stratified by the type of surgery to observe the incidence rate of residual paralysis in the recovery room Group A will receive extubation strategy without additional oxygen supplementation while Group B will use extubation strategy with quantitative TOF monitoring
Group A will receive optimal reversal strategy using neostigmine based on clinical criteria such as tidal volume adequacy and the time of last administration of the neuromuscular blockade agent Then patients will be assessed 15 minutes after reversal for the ability to maintain oxygen saturation levels 95 without oxygen supplementation If they meet these criteria patients will then be extubated Group B will receive optimal reversal strategy using neostigmine based on TOF values If the measured TOF value is 090 patients can be extubated while awake Upon arrival in the recovery room the TOF values of both groups will be measured and compared as the outcome of this study
The results of this study are expected to provide recommendations for extubation strategies based on clinical parameters to clinicians with limited access to TOF monitoring devices With the implementation of this change in extubation strategy unexpected post-anesthesia events may be reduced
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