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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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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.
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To compare between three different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ● Group P1 (N 15) Patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml). |
Drug: Pilocaine 2%
Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows:
Group P1 (N 15): patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
Other Names:
|
| Active Comparator: ● Group P2 (N 15) Patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). |
Drug: Pilocaine 2%
Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows:
Group P1 (N 15): patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
Other Names:
|
| Active Comparator: ● Group P3 (N 15) patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml) |
Drug: Pilocaine 2%
Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows:
Group P1 (N 15): patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Duration of motor Block in hours [Through Study Completion,an average of 1day]
The primary outcome measure will be duration of motor Block in minutes, defined as the duration between intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block).
Secondary Outcome Measures
- Onset of sensory block in minutes [Through Study Completion,an average of 1day]
Onset of sensory block, defined as the duration between intrathecal drug injection and complete absence of skin sensation to the pinprick test at T10 dermatome level in minutes.
- Onset of motor block in minutes [Through Study Completion,an average of 1day]
Onset of motor block, defined as the duration between intrathecal drug injection and reaching a Bromage's score ≥ 2 in minutes.
- Highest dermatomal level of sensory block. [Through Study Completion,an average of 1day]
Highest dermatomal level of sensory block.
- Time to reach to highest sensory block in minutes. [Through study completion,an average of 1day]
Time to reach to highest sensory block in minutes.
- Motor block at the time of reaching highest sensory block. [through study completion,an average of 1day]
Motor block at the time of reaching highest sensory block.
- Full regression of sensory block [Through Study Completion,an average of 1day]
Full regression of sensory block, defined as the duration between intrathecal drug injection and regression to the S2 dermatome in minutes.
- Duration of PACU stay [Through Study Completion,an average of 1day]
Duration of Post Anesthesia Care Unit stay in minutes.
- The incidence of adverse effects [Through Study Completion,an average of 1day]
The incidence of adverse effects like hypotension, bradycardia, apnea, nausea, shivering, pruritus, block failure and pain during the operation. Failure to achieve a block level of T10 or additional analgesia request will be considered as block failure. Hypotension will be defined as a systolic blood pressure of < 90 mmHg or a decrease in mean arterial pressure of more than 20% from baseline preoperative value and bradycardia will be defined as heart rate < 50 beat/min.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age (65 - 80)
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ASA I - III
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Both genders.
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Height (1.60-1.90) m.
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BMI (18.5-40) kg m-2
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Scheduled for elective day-case lower abdominal or urologic procedures < 90 minutes in duration under spinal anesthesia.
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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:
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Patients requiring general anesthesia.
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Operations requiring sensory block above T10.
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Known or suspected coagulopathy (international normalised ratio > 1.4), thrombocytopenia (platelet count < 100,000).
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Known peripheral neuropathy, neurological deficits or skeletal deformities.
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Known allergy to prilocaine.
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Infection at site of injection.
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Patients' refusal to sign informed consent.
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Patients 'not meet inclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ahmed Abdalla Mohamed | Cairo | Egypt | 11451 |
Sponsors and Collaborators
- Cairo University
- Norhan Abdel Aleem Ali
- Hagar Hassanein Refaee
- Ahmed Abdullah Fathi Mohamed Almadawi
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MD-248-2022