Effect of Drug
Conditions
Brief summary
This study aims to compare effect of adding fentanyl or dexmetomidine on duration of motor and sensory block after spinal anesthesia with prilocaine during day case perianal surgery and whether it impact time to discharge home.
Interventions
A peripheral intravenous (IV) catheter will be inserted, and a 7 mL kg-1 crystalloid infusion will be initiated. The patients will be premedicated with 0.03 mg kg-1 midazolam IV. Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 min intervals during the procedure and at 15 min intervals during the post anesthesia care unit (PACU) stay. The baseline values will be recorded. Nasal oxygen 2 L min-1 will be administered during the whole procedure
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-70 * ASA 1-3 * height \<155cm or \>175cm * Day case perianal surgery
Exclusion criteria
* Hypersensitivity to the study drugs * Refusal of patients. * Patients with contraindications for spinal anesthesia * previous voiding difficulty * patients taking anticholinergic medications. * emergency cases * Patients with contraindications for day case sitting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory block resolution to S3 block | at 1 min intervals until the maximum block will be achieved and at 15 min intervals thereafter until the block resolved to S3 dermatome. | The sensory block will be measured at the midclavicular line with a pinprick test (via a 22 gauge hypodermic needle) |
| Home discharge | Home discharge will be assessed as the time from the end of surgery until the patients reach a post-anesthesia discharge score | (modified Alderts score) ≥9, able to void spontaneously and the sensory block resolves to the S3 dermatome. |
| incidence of postoperative urinary retention (POUR) | within 6 hours after surgery | The postoperative urinary retention (POUR) will be evaluated at hourly intervals in the PACU and ward; ultrasonic bladder scanning will be used for this purpose. If the bladder volume exceeds 500 mL and the patient has not voided spontaneously, urinary catheterization will be introduced. |
Countries
Egypt
Outcome results
None listed