Intrathecal Dexmedetomidine vs Midazolame

NCT ID: NCT06315634

Last Updated: 2024-03-18

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-03-10

Brief Summary

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

Detailed Description

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Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Heavy Bupivacaine plus normal saline

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

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine

Heavy Bupivacaine plus dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

5 micrograms intrathecal dexmedetomidine

Bupivacain

Intervention Type DRUG

12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine

Heavy Bupivacaine plus midazolam

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

2 milligrams intrathecal midazolam

Bupivacain

Intervention Type DRUG

12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine

Interventions

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Dexmedetomidine

5 micrograms intrathecal dexmedetomidine

Intervention Type DRUG

Midazolam

2 milligrams intrathecal midazolam

Intervention Type DRUG

Bupivacain

12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine

Intervention Type DRUG

Other Intervention Names

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Spinal dexmedetomidine Spinal midazolam Spinal bupivacaine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Said Nasef Zedan

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Elwasef, MD

Role: STUDY_DIRECTOR

NCI Egypt

Locations

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National cancer institute

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP210330102

Identifier Type: -

Identifier Source: org_study_id

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