Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382220
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-19
Brief Title:
Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics
Sponsor:
Fayoum University Hospital
Organization:
Fayoum University Hospital
Study Overview
Official Title:
Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics A Randomized Double-Blind Comparative Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Orthopedic interventions under spinal anesthesia is considered a common practice in elderly patients undergo surgery and may be associated with lower risks of death deliriumand major medical complications
Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness The degree of hypotension is proportional to the extent of sympathetic blockade thus unilateral Spinal anesthesia described by Tanasichuk et AL was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade
Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries It provides a short motor block onset time with a long motor block duration If bupivacaine is used the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time dermatomal spread and motor block duration Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine In the last decade and with the development of day surgery prilocaine 2 has become more commonly used for orthopaedic surgical procedures Prilocaine induces a shorter motor block with less urinary retention which better facilitates enhanced recovery after surgery Usually doses administered in spinal anaesthesia vary from 20 to 80 mg Given the intermediate motor block duration
The aim of this study
To compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people
Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness The degree of hypotension is proportional to the extent of sympathetic blockade thus unilateral Spinal anesthesia described by Tanasichuk et AL was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade
Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries It provides a short motor block onset time with a long motor block duration If bupivacaine is used the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time dermatomal spread and motor block duration Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine In the last decade and with the development of day surgery prilocaine 2 has become more commonly used for orthopaedic surgical procedures Prilocaine induces a shorter motor block with less urinary retention which better facilitates enhanced recovery after surgery Usually doses administered in spinal anaesthesia vary from 20 to 80 mg Given the intermediate motor block duration
The aim of this study
To compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people
Detailed Description:
This study will be performed in the in the FAYOUM University hospital after the local Institutional Ethics Committee and local institutional review board approval The study design will be double-blind randomized controlled study A detailed informed consent will be signed by the eligible patients before recruitment and randomization
Population of Study
Group 1 Group A Bupivacaine group n 50 patients who received 75 mg low dose hyperbaric bupivacaine 05 Marcaine AstraZeneca Sweden in 2 mL volume 15 mL hyperbaric bupivacaine 05 diluted with 05 mL sterile distilled water intrathecal at level lumbar L3-L4 or L4-L5 in lateral decubitus position keeping the operated side dependent and remained in this position for 10 min before turning supine
Group 2 Group B Prilocaine group n 50 patients received 40 mg low dose intrathecal hyperbaric prilocaine 2 Takipril Sunny Medical group Egypt under liscense from Sintetica Switzerlandin 2 mL volume as described in group A The injection will be in the midline over 30 s by 25 gauge G Quincke needle under strict aseptic condition
Inclusion Criteria
100 elderly patients 60 years old or above of either gender with American Society of Anesthesiologists ASA physical status I II and III who were scheduled for elective knee and below knee orthopedic surgeries expected to the last for 40-60 min under spinal anesthesia
Exclusion Criteria
Patients height 155 or 175 m with other neurological diseases spine abnormalities absolute and relative contraindications to spinal anesthesia as patients suffering from intracranial hypertension major bleeding disorder patients on anticoagulant local infection dementia and allergic reaction to local anesthetics
Sample Size number of participants included 100 patients
Methodology in details
All patients received Ringers lactate infusion 5 mL kg and maintained intraoperatively with a rate of 5 mLkgh before performance of subarachnoid blockade Baseline heart rate HR systolic blood pressure SBP diastolic blood pressure DBP mean arterial pressure MAP and oxygen saturation SpO2 were recorded Patients were allocated to either study groups using a randomized central computer generated sequence and a sealed envelope assignment held by an investigator not involved with the clinical management or data collection and they were randomly allocated into two groups as follows Group A Bupivacaine group n 50 patients who received 75 mg low dose hyperbaric bupivacaine 05 Marcaine AstraZeneca Sweden in 2 mL volume 15 mL hyperbaric bupivacaine 05 diluted with 05 mL sterile distilled water intrathecal at level lumbar L3-L4 or L4-L5 in lateral decubitus position keeping the operated side dependent and remained in this position for 10 min before turning supine Moreover Group B Prilocaine group n 50 patients received 40 mg low dose intrathecal hyperbaric prilocaine 2 Takipril Sunny Medical group Egypt under liscense from Sintetica Switzerlandin 2 mL volume as described in group A The injection will be in the midline over 30 s by 25 gauge G Quincke needle under strict aseptic condition The study solution was prepared by another investigator and its content blinded to the anesthetist who administered it the anesthesiologist who will collect the data will be unaware about any of the experimental groups If adequate surgical anesthesia was not achieved general anesthesia was performed and patient was excluded from our study HR SBP DBP MAP and SpO2 were recorded every 5-minute interval until the end of the surgery
Population of Study
Group 1 Group A Bupivacaine group n 50 patients who received 75 mg low dose hyperbaric bupivacaine 05 Marcaine AstraZeneca Sweden in 2 mL volume 15 mL hyperbaric bupivacaine 05 diluted with 05 mL sterile distilled water intrathecal at level lumbar L3-L4 or L4-L5 in lateral decubitus position keeping the operated side dependent and remained in this position for 10 min before turning supine
Group 2 Group B Prilocaine group n 50 patients received 40 mg low dose intrathecal hyperbaric prilocaine 2 Takipril Sunny Medical group Egypt under liscense from Sintetica Switzerlandin 2 mL volume as described in group A The injection will be in the midline over 30 s by 25 gauge G Quincke needle under strict aseptic condition
Inclusion Criteria
100 elderly patients 60 years old or above of either gender with American Society of Anesthesiologists ASA physical status I II and III who were scheduled for elective knee and below knee orthopedic surgeries expected to the last for 40-60 min under spinal anesthesia
Exclusion Criteria
Patients height 155 or 175 m with other neurological diseases spine abnormalities absolute and relative contraindications to spinal anesthesia as patients suffering from intracranial hypertension major bleeding disorder patients on anticoagulant local infection dementia and allergic reaction to local anesthetics
Sample Size number of participants included 100 patients
Methodology in details
All patients received Ringers lactate infusion 5 mL kg and maintained intraoperatively with a rate of 5 mLkgh before performance of subarachnoid blockade Baseline heart rate HR systolic blood pressure SBP diastolic blood pressure DBP mean arterial pressure MAP and oxygen saturation SpO2 were recorded Patients were allocated to either study groups using a randomized central computer generated sequence and a sealed envelope assignment held by an investigator not involved with the clinical management or data collection and they were randomly allocated into two groups as follows Group A Bupivacaine group n 50 patients who received 75 mg low dose hyperbaric bupivacaine 05 Marcaine AstraZeneca Sweden in 2 mL volume 15 mL hyperbaric bupivacaine 05 diluted with 05 mL sterile distilled water intrathecal at level lumbar L3-L4 or L4-L5 in lateral decubitus position keeping the operated side dependent and remained in this position for 10 min before turning supine Moreover Group B Prilocaine group n 50 patients received 40 mg low dose intrathecal hyperbaric prilocaine 2 Takipril Sunny Medical group Egypt under liscense from Sintetica Switzerlandin 2 mL volume as described in group A The injection will be in the midline over 30 s by 25 gauge G Quincke needle under strict aseptic condition The study solution was prepared by another investigator and its content blinded to the anesthetist who administered it the anesthesiologist who will collect the data will be unaware about any of the experimental groups If adequate surgical anesthesia was not achieved general anesthesia was performed and patient was excluded from our study HR SBP DBP MAP and SpO2 were recorded every 5-minute interval until the end of the surgery
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?:
False
Is an FDA AA801 Violation?:
None