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

NCT ID: NCT03438240

Last Updated: 2018-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2018-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group BF

Bupivacaine plus Fentanyl

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Fentanyl

Intervention Type DRUG

Plus 50 µg fentanyl

Group BD

Bupivacaine plus Dexmedetomidine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Dexmedetomidine

Intervention Type DRUG

Plus 50 µg dexmedetomidine

Interventions

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Bupivacaine

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

Intervention Type DRUG

Fentanyl

Plus 50 µg fentanyl

Intervention Type DRUG

Dexmedetomidine

Plus 50 µg dexmedetomidine

Intervention Type DRUG

Other Intervention Names

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Local anesthetic Opioid alpha 2 sympathomimetic

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amin Mohammed Alansary Amin Ahmed Helwa

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R8 /2018

Identifier Type: -

Identifier Source: org_study_id

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