NCT07088016

Brief Summary

The goal of this observational study is to compare the effectiveness and patient satisfaction of local anesthesia combined with intravenous Dexmedetomidine versus epidural anesthesia in endoscopic lumbar discectomy surgeries

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

July 9, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

epiduraldexmedetomidinemicroscopic lumber discectomy

Outcome Measures

Primary Outcomes (1)

  • we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver

    It refers to the common method used in healthcare where patients rate their pain on a scale from 0 to 10: 0 = No pain 10 = Worst pain imaginable.

    from January 2021 to January 2024

Secondary Outcomes (3)

  • Heart rate (H.R)

    from January 2021 to January 2024

  • Mean arterial blood pressure (MABP)

    from January 2021 to January 2024

  • we compare Bromage scale in the two groups intraoperative during foraminal dilatation by the surgeon

    from January 2021 to January 2024

Study Arms (2)

dexmedetomidine group

loading of Dexmedetomidine was done at a dose of 1 mcg/ kg over 10 minutes followed by continuous infusion at a rate of 0.5 mcg/kg/hr , followed by infiltration of the skin with 2-3 ml of lidocaine hydrochloride 1 % first by the surgeon then an 18 -G needle will be introduced to anesthetize the trajectory with 8-10 ml lidocaine 1 %. After reaching the superior articular process, 2-3 ml of lidocaine 1 % was used to anesthetize the facet joint.

Epidural group

The epidural insertion point was 2 segments upper than the surgical procedure, 10 ml of Bupivacaine 0.25% was injected in the epidural space to adjust the sensory level. The epidural catheter will be removed after 2 hours from the end of the operation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients are American Society of anesthesiologists' physical status (ASA) I to II aged 18 to 60 years of both sexes with clinical and radiological evidence of soft disc herniation in a single lumber segment.

You may qualify if:

  • Patients American Society of anesthesiologists' physical status (ASA) I to II.
  • Aged 18 to 60 years.
  • Both sexes.
  • Patients with clinical and radiological evidence of soft disc herniation in a single lumber segment.

You may not qualify if:

  • Spinal malformation
  • Recurrent lumber disc herniation (LDH)
  • Multi segment LDH
  • Patients younger than 18 years or older than 60 years
  • Patients with hypersensitivity to one of the used drugs
  • Patients suffering of coagulopathy
  • Operation time more than 1 hour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Medical Center

Cairo, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 28, 2025

Study Start

January 1, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

"IPD will not be shared due to concerns regarding participant privacy, confidentiality, and regulatory limitations. In addition, appropriate consent for data sharing may not have been obtained from participants at the time of enrollment

Locations