Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 1:44 PM
Study NCT ID:
NCT07114250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Supine Percutaneous Nephrolithotomy Operation
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Patients Undergoing Supine Percutaneous Nephrolithotomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
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:
The aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in PCNL operation in supine position.
Detailed Description:
Nephrolithiasis remains a common health problem around the globe. Percutaneous nephrolithotomy is the preferred modality for large and complex renal calculi. Percutaneous nephrolithotomy is the treatment of choice for calculi which fail treatment with extracorporeal shockwave lithotripsy and ureteral endoscopy.
There are variations to Percutaneous nephrolithotomy, including position, imaging modality, dilatation method, and anesthesia method. There is conflicting evidence between the appropriate use of general anesthesia versus spinal anesthesia for Percutaneous nephrolithotomy
The conventional position of Percutaneous nephrolithotomy is prone, which allows direct access to the posterior calyx with minimal risk of bowel puncture.
However, this positioning method limits the possibility of switching anesthesia from regional to general. The alternative position is supine Advantage in this position is that the spine does not overlap with kidney and fluoroscopic visualization can be achieved.
Nowadays, Percutaneous nephrolithotomy is usually performed under general anesthesia from a urological perspective, the particular advantages of general anesthesia in Percutaneous nephrolithotomy procedure include its feasibility to control tidal volume, secure patient airway, and extensibility of anesthesia time. The feasibility of controlling tidal volume minimizes renal mobility secondary to respiration while the extensibility of anesthesia time allows the surgeon to create multiple punctures with subsequently increased efficacy of the procedure . Despite the superior results of Percutaneous nephrolithotomy surgeries under general anesthesia, it has found to be associated with certain disadvantages such as its high cost and higher incidences of drug interactions. The incidence of complications is high especially when the position of patient is changed from supine to prone position. Common complications associated with use of general anesthesia i.e. injury to lung, brachial plexus, tongue and occasionally to spinal cord are its major drawback. Other minor but common side effects include postoperative nausea and vomiting On the other hand, there are recent reports regarding the use of spinal anesthesia in Percutaneous nephrolithotomy demonstrating lower post-operation pain, less drug intake, less bleeding, and reduces venous pressure in the surgery field .A limited number of prospective randomized trials have been carried out to establish which one of these procedures is better at decreasing perioperative complications. The influence of the type of anesthesia on the effectiveness of Percutaneous nephrolithotomy remains uncertain. Thus, the aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in Percutaneous nephrolithotomy operation in supine position.
The aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in Percutaneous nephrolithotomy operation in supine position.
Primary outcome:
• Patient satisfaction
There are variations to Percutaneous nephrolithotomy, including position, imaging modality, dilatation method, and anesthesia method. There is conflicting evidence between the appropriate use of general anesthesia versus spinal anesthesia for Percutaneous nephrolithotomy
The conventional position of Percutaneous nephrolithotomy is prone, which allows direct access to the posterior calyx with minimal risk of bowel puncture.
However, this positioning method limits the possibility of switching anesthesia from regional to general. The alternative position is supine Advantage in this position is that the spine does not overlap with kidney and fluoroscopic visualization can be achieved.
Nowadays, Percutaneous nephrolithotomy is usually performed under general anesthesia from a urological perspective, the particular advantages of general anesthesia in Percutaneous nephrolithotomy procedure include its feasibility to control tidal volume, secure patient airway, and extensibility of anesthesia time. The feasibility of controlling tidal volume minimizes renal mobility secondary to respiration while the extensibility of anesthesia time allows the surgeon to create multiple punctures with subsequently increased efficacy of the procedure . Despite the superior results of Percutaneous nephrolithotomy surgeries under general anesthesia, it has found to be associated with certain disadvantages such as its high cost and higher incidences of drug interactions. The incidence of complications is high especially when the position of patient is changed from supine to prone position. Common complications associated with use of general anesthesia i.e. injury to lung, brachial plexus, tongue and occasionally to spinal cord are its major drawback. Other minor but common side effects include postoperative nausea and vomiting On the other hand, there are recent reports regarding the use of spinal anesthesia in Percutaneous nephrolithotomy demonstrating lower post-operation pain, less drug intake, less bleeding, and reduces venous pressure in the surgery field .A limited number of prospective randomized trials have been carried out to establish which one of these procedures is better at decreasing perioperative complications. The influence of the type of anesthesia on the effectiveness of Percutaneous nephrolithotomy remains uncertain. Thus, the aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in Percutaneous nephrolithotomy operation in supine position.
The aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in Percutaneous nephrolithotomy operation in supine position.
Primary outcome:
• Patient satisfaction
Study Oversight
Has Oversight DMC:
False
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?: