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

NCT03438240 | Completed Phase 4

• 1 other identifier: FMASU R8 /2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• First time to analgesic requirement

  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.

  First 24 hours postoperatively

Secondary Outcomes (2)

• Total opioid consumption

  First 24 hours postoperatively

• Visual analogue scale (VAS)

  First 24 hours postoperatively

Study Arms (2)

Group BF

ACTIVE COMPARATOR

Bupivacaine plus Fentanyl

Drug: Bupivacaine; Drug: Fentanyl

Group BD

ACTIVE COMPARATOR

Bupivacaine plus Dexmedetomidine

Drug: Bupivacaine; Drug: Dexmedetomidine

Interventions

Bupivacaine DRUG

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

Also known as: Local anesthetic

Group BD; Group BF

Fentanyl DRUG

Plus 50 µg fentanyl

Also known as: Opioid

Group BF

Dexmedetomidine DRUG

Plus 50 µg dexmedetomidine

Also known as: alpha 2 sympathomimetic

Group BD

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Anesthetics, Local; Fentanyl; Analgesics, Opioid; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Narcotics; Analgesics; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: February 12, 2018
• Primary Completion: July 5, 2018
• Study Completion: August 15, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-02

Locations

EG (1)