Cystoscopic Procedures, Hyperbaric Bupivacaine, Hyperbaric Prilocaine, Intrathecal Injection
Conditions
Brief summary
This study aims to compare the intrathecal injection of hyperbaric prilocaine 2% versus hyperbaric bupivacaine 0.5% in cystoscopy procedures.
Detailed description
Cystoscopy is a short surgical procedure in the field of urology that is very frequently performed. Spinal anesthesia (SA) is the choice because it has an easy implementation technique, fast onset, and low complications compared to general anesthesia. One of the spinal anesthetic regimens often used is 0.5% hyperbaric bupivacaine, which has a two-segment regression time of around 65 minutes and requires 164 minutes for complete regression to the sacral dermatomes. However, bupivacaine, when used for relatively short procedures, causes various disadvantages including prolonged effects. Prilocaine is an alternative to bupivacaine in short surgical procedures, including cystoscopy. It has a profile similar to lidocaine but with less neurotoxicity.
Interventions
DRUGBupivacaine
Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml).
DRUGPrilocaine
Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml).
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 65 years. * Both Sexes. * American Society of Anesthesiologists (ASA) physical status I-II. * Normal body mass index (BMI) 18-25. * Undergoing cystoscopic procedure under spinal anesthesia.
Exclusion criteria
* \- Patient's refusal. * History of allergy to local anesthetics (hyperbaric prilocaine or hyperbaric bupivacaine). * History of impaired gait before the study. * Contraindications to SA including :- * Coagulopathy. * Elevated intracranial pressure (ICP). * Infection at the site. * Spinal cord disorder. * Severe hypovolemia. * Uncontrolled hypertension systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg. * Uncontrolled Diabetes mellitus HbA1c ≥ 8.5%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery time | Till discharge (Up to 4 hours) | Recovery time defined as the time required until the patient is ready for discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of side effects | 24 hours postoperatively | Incidence of side effects such as hypotension, bradycardia, nausea, vomiting, pruritus, and urinary retention were recorded. |
| Noninvasive Blood pressure | Till discharge from hospital (Up to 2 hours) | Noninvasive Blood pressure was monitored every 3 min for the first 15 minutes. |
| Heart rate | Till discharge from hospital (Up to 2 hours) | Heart rate was monitored every 3 min for the first 15 minutes. |
| Degree of patient satisfaction | 24 hours postoperatively | Degree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor). |
Countries
Egypt
Outcome results
None listed