Trials / Completed
CompletedNCT05596552
Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Ain Shams University · Academic / Other
- Sex
- All
- Age
- 21 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study was to assess the effect of intrathecally injected 5 µg dexmedetomidine or 25 µg fentanyl as adjuvants to bupivacaine in low dose spinal anesthesia for unilateral arthroscopic knee surgeries, on post-operative urinary retention (POUR), time needed to reach sensory block at the tenth thoracic dermatome (T10), the maximum sensory level achieved, the onset of motor block, the intra-operative fluids given, the duration of sensory and motor blocks, time to micturition or insertion of an intermittent urinary catheter and the number of patients who needed an indwelling (Foley's) catheter. Seventy patients, ASA physical status I or II, from 21 to 50 years old, scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia, were randomly divided into two equal groups; the Bupivacaine- Dexmedetomidine group (BD) patients and the Bupivacaine-Fentanyl group (BF) patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | hyperbaric bupivacaine and dexmedetomidine | In a 3 ml syringe, 5 µg dexmedetomidine was added to the 2 ml of 10 mg hyperbaric bupivacaine, to have a total volume of 2.5 ml for intrathecal spinal injection over 3 minute without barbotage |
| DRUG | Bupivacaine-Fentanyl group | In a 3 ml syringe, 25 μg fentanyl was added to the 2 ml of 10 mg hyperbaric bupivacaine, to have a total volume of 2.5 ml for intrathecal spinal injection over 3 minute without barbotage |
Timeline
- Start date
- 2021-10-15
- Primary completion
- 2022-05-25
- Completion
- 2022-07-15
- First posted
- 2022-10-27
- Last updated
- 2022-10-27
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05596552. Inclusion in this directory is not an endorsement.