Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block (saddle)

Zulekha Hospitals

Status: Completed

Conditions: Regional Anesthesia Morbidity

Treatments: Drug: DEX group; Drug: FENT group

Study type: Interventional

Funder types: Other

Identifiers

NCT06216197

0395/2023

Details and patient eligibility

About

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

Full 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).

Enrollment: 58 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• both sexes
• aged between 20 and 60
• classified as II & ASA-I
• scheduled for elective anal surgeries

Exclusion criteria

• subjects who refused to participate
• uncontrolled hypertension
• BMI > 30 kg/m2
• heart failure (class IV or III) based on the New York Heart Association (NYHA)
• uncorrected coagulopathy
• any study's drug allergy
• drug abuse
• neuropathy
• any spinal anesthesia contraindication (such as infection or a pelvic fracture)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

The FENT Group

Other group

Description:

Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).

Treatment:

Drug: FENT group

The DEX Group

Other group

Description:

The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Treatment:

Drug: DEX group