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

Adding Dexmedetomidine Versus Fentanyl to Bupivacaine for Epidural Analgesia in Combination With General Anesthesia for Elective Lumbar Disc Operations: Prospective, Randomized Double-blinded Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03438240

Enrollment

Registered

2018-02-19

Start date

2018-02-12

Completion date

2018-08-15

Last updated

2018-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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.

Interventions

DRUGBupivacaine

patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%

DRUGFentanyl

Plus 50 µg fentanyl

DRUGDexmedetomidine

Plus 50 µg dexmedetomidine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
First time to analgesic requirement	First 24 hours postoperatively	After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time.

Secondary

Measure	Time frame	Description
Total opioid consumption	First 24 hours postoperatively	Total morphine consumption per twenty four hours will be estimated
Visual analogue scale (VAS)	First 24 hours postoperatively	Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU, and 10, 20, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026