An interventional study of FENT group and DEX group in Regional Anesthesia Morbidity, sponsored by Zulekha Hospitals. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Zulekha Hospitals · Not applicable, Interventional, and Screening
Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures.
Objectives: A saddle spinal block is a viable choice for anal surgeries. This technique effectively maintains balanced hemodynamics, and fast recovery, and prevents irrelevant motor blocks in both limbs.
Methods: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). Continuous monitoring of HR and SpO2 was conducted. Evaluation of sensory blockage and the motor block was done utilizing the Bromage scale. Following surgery, assessments were conducted. Pain in the ward and PACU was determined utilizing the visual analog scale (VAS).
Zulekha Hospitals is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).
Drug: FENT group
The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
Drug: DEX group
Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).
Also known as: fentanyl group
The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
Also known as: dexmedetomidine group
the duration until the first call for analgesia
the duration until the first call for analgesia
Time frame: 20 months
the duration from spinal injection until reaching the maximal sensory level
the duration from spinal injection until reaching the maximal sensory level
Time frame: 20 months
the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level
the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level
Time frame: 20 months
the time required for sensory regression until reaching the S1 level (from the maximal sensory level)
the time required for sensory regression until reaching the S1 level (from the maximal sensory level)
Time frame: 20 months
the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)
the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)
Time frame: 20 months
side effects occurrences
side effects occurrences
Time frame: 20 months
Plan to share: No — available
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Zulekha Hospitals