Clinical Trials Directory

Trials / Completed

CompletedNCT06216197

Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block

Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block for Various Anal Surgeries: A Correlative Randomized Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Zulekha Hospitals · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Accepted

Summary

Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
DRUGFENT groupGroup FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).
DRUGDEX groupThe DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Timeline

Start date
2021-04-03
Primary completion
2022-12-04
Completion
2022-12-04
First posted
2024-01-22
Last updated
2024-01-22

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06216197. Inclusion in this directory is not an endorsement.