Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03438240

FMASU R8 /2018

Details and patient eligibility

About

The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.

Enrollment: 80 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physical status American Society of Anesthesiologist (ASA) I or II.
• First time elective lumbar dicsectomy or laminectomy

Exclusion criteria

• Patients who refuse to participate
• Body mass index (BMI) > 30
• Need an emergency lumbar disc operation
• ASA physical status > II
• Major illnesses (e.g. cardiac, respiratory, renal, liver)
• Coagulation abnormalities
• Hypovolemia
• History of increased intracranial pressure
• Convulsions
• Spinal stenosis
• Infection at needle insertion site
• Other contraindications to epidural procedure
• Allergy or contraindications to the drugs used in the study
• History of addiction or alcohol abuse
• Psychiatric illness or mental retardation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups

Group BF

Active Comparator group

Description:

Bupivacaine plus Fentanyl

Treatment:

Drug: Bupivacaine

Drug: Fentanyl

Group BD

Active Comparator group

Description:

Bupivacaine plus Dexmedetomidine

Treatment:

Drug: Bupivacaine

Drug: Dexmedetomidine