Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05834647
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-28
First Post:
2023-03-29
Brief Title:
Efficacy and Safety of Prilocaine 2 and Lidocaine 5 Hyperbaric Against Spinal Anesthesia in Post Cystoscopy Procedure
Sponsor:
Universitas Sebelas Maret
Organization:
Universitas Sebelas Maret
Study Overview
Official Title:
Efficacy and Safety of Prilocaine 2 and Lidocaine 5 Hyperbaric Against Spinal Anesthesia in Post Cystoscopy Procedure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
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:
Regional anesthesia is defined as the temporary removal of nerve conduction and pain in certain areas of the body with local anesthetic drugs without causing loss of consciousness Spinal anesthesia can provide better analgesia and shorter recovery time in urological procedures resulted in shorter operating times lower postoperative pain lower analgesic requirements and shorter length of stay LOS compared to the general anesthesia Lidocaine is an attractive regional anesthesia drug for ambulatory surgery since it has a rapid onset and rapid recovery from motor and sensory block However when it is compared with other local anesthetic agents the use of lidocaine in spinal anesthesia is associated with an increased risk of transient neurologic symptoms thus impeding its application to outpatient spinal anesthesia Lidocaine is more neurotoxic than other local anesthetic agents especially when high concentrations are applied directly to nervous tissue Another local anesthetic agent can be used is prilocaine It has medium potency rapid duration and rapid onset of action Compared with lidocaine prilocaine has a lower incidence of neurological symptoms in spinal anesthesia for outpatient surgery and suitable as an alternative to long-acting low-dose local anesthetics Therefore the investigators intend to observe the efficacy and safety of these two agents in adult patients who will undergo cystoscopy procedure using spinal anesthesia In this study the investigators used high-sensitivity C-Reactive Protein hs-CRP and high-sensitive Troponin hs-Troponin CRP is a systemic inflammation marker associated with conditions such as pain Troponin can represent patients kidney function since its metabolism and excretion are affected by changes of estimated glomerular filtration rate eGFR Previous study also showed that the use of spinal anesthesia can reduce the incidence of acute kidney injury Therefore the investigators aim to carry out further examination of the following two markers regarding to spinal anesthesia using lidocaine and prilocaine
Detailed Description:
The investigators will conduct a double-blind randomized controlled trial to compare hs-CRP and hs-Troponin levels between prilocaine 2 and hyperbaric lidocaine 5 in adult patients undergoing cystoscopy procedure with spinal anesthesia This study was approved by the Health Research Ethics Committee Institutional Review Board of Dr Moewardi General Hospital Surakarta Before randomization participants who are eligible based on inclusion and exclusion criteria will be given informed consent If the patients agree the patient will be included in this research Ninety adult patients will be randomly divided into control group and treatment group Control group group L will be given 1 mL hyperbaric lidocaine 5 50 mg and treatment group group P will be given 25 mL prilocaine 2 50 mg as spinal anesthesia The investigators will measure hs-CRP serum levels and hs-Troponin serum levels as the primary outcome Serum levels of hs-CRP dan hs-Troponin will be measured 4 hours postoperative
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