Clinical trial NCT05726968: A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.
Official title: A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Norhan Abdel Aleem Ali
name: Hagar Hassanein Refaee
name: Ahmed Abdullah Fathi Mohamed Almadawi
First posted: 2023-02-14
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The purpose of this study is to determine the least sufficient dose of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg required for day-case lower abdominal and urologic surgeries , fewer adverse effects, faster recovery time, and shorter stay in post anesthesia care unit (PACU) in the geriatric patient population, as a previous study has investigated hyperbaric prilocaine (30 mg) when combined with fentanyl (20 µg) for a day-case perianal surgery, achieving a spinal anaesthesia with a mean sensory level of T9
Primary purpose: DIAGNOSTIC

Brief summary: To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population.

Detailed description: * To evaluate the safety and effectiveness of spinal anaesthesia with hyperbaric Prilocaine 2% in a reduced dose (30mg) in combination with Fentanyl (25µg) in day-case lower abdominal and urologic surgeries in the geriatric population.
* To compare between three different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
* To estimate the duration of stay in PACU and hospital stay with different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.

Eligibility criteria: Inclusion Criteria:

* Age (65 - 80)
* ASA I - III
* Both genders.
* Height (1.60-1.90) m.
* BMI (18.5-40) kg m-2
* Scheduled for elective day-case lower abdominal or urologic procedures \< 90 minutes in duration under spinal anesthesia.
* Type of surgery: Inguinal, femoral and incisional herniorrhaphies, bilateral varicocelectomies, hydrocelectomy, lymph node biopsies and mass excision biopsies, TURP surgery, Cystoscopies, ureteroscopy, bladder stone extraction, DJ insertion.

Exclusion Criteria:

* Patients requiring general anesthesia.
* Operations requiring sensory block above T10.
* Known or suspected coagulopathy (international normalised ratio \> 1.4), thrombocytopenia (platelet count \< 100,000).
* Known peripheral neuropathy, neurological deficits or skeletal deformities.
* Known allergy to prilocaine.
* Infection at site of injection.
* Patients' refusal to sign informed consent.
* Patients 'not meet inclusion criteria.

Primary outcomes:
measure: Duration of motor Block in hours
timeFrame: Through Study Completion,an average of 1day
Secondary outcomes:
measure: Onset of sensory block in minutes
timeFrame: Through Study Completion,an average of 1day
measure: Onset of motor block in minutes
timeFrame: Through Study Completion,an average of 1day
measure: Highest dermatomal level of sensory block.
timeFrame: Through Study Completion,an average of 1day
measure: Time to reach to highest sensory block in minutes.
timeFrame: Through study completion,an average of 1day
measure: Motor block at the time of reaching highest sensory block.
timeFrame: through study completion,an average of 1day
measure: Full regression of sensory block
timeFrame: Through Study Completion,an average of 1day
measure: Duration of PACU stay
timeFrame: Through Study Completion,an average of 1day
measure: The incidence of adverse effects
timeFrame: Through Study Completion,an average of 1day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
References: