NCT06315634

Brief Summary

Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

February 9, 2024

Last Update Submit

March 13, 2024

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Duration of sensory block

    Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation

    12 hours

Secondary Outcomes (5)

  • Incidence of vomiting occurrence

    12 hours

  • Sedation

    12 hours

  • Change in mean arterial blood pressure

    12 hours

  • Duration of motor block

    12 hours

  • Change in heart rate

    12 hours

Study Arms (3)

Heavy Bupivacaine plus normal saline

ACTIVE COMPARATOR

2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline

Drug: Bupivacain

Heavy Bupivacaine plus dexmedetomidine

EXPERIMENTAL

2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline

Drug: DexmedetomidineDrug: Bupivacain

Heavy Bupivacaine plus midazolam

EXPERIMENTAL

2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline

Drug: MidazolamDrug: Bupivacain

Interventions

DexmedetomidineDRUG

5 micrograms intrathecal dexmedetomidine

Also known as: Spinal dexmedetomidine
Heavy Bupivacaine plus dexmedetomidine
MidazolamDRUG

2 milligrams intrathecal midazolam

Also known as: Spinal midazolam
Heavy Bupivacaine plus midazolam
BupivacainDRUG

12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine

Also known as: Spinal bupivacaine
Heavy Bupivacaine plus dexmedetomidineHeavy Bupivacaine plus midazolamHeavy Bupivacaine plus normal saline

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing lower limb orthopedic cancer surgery.
  • ASA I, II, III.
  • Age 20 to 70 year
  • Healthy volunteers

You may not qualify if:

  • Age less than 20 and older than 70.
  • ASA IV, V.
  • patients' refusal.
  • patients with coagulopathy.
  • patients with severe valvular stenosis
  • patients with infection at site of injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National cancer institute

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexmedetomidineMidazolamBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mohamed Elwasef, MD

    NCI Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 9, 2024

First Posted

March 18, 2024

Study Start

March 15, 2021

Primary Completion

March 10, 2022

Study Completion

March 10, 2022

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations

EG(1)