Intrathecal Dexmedetomidine vs Midazolame

March 13, 2024 updated by: Mohammed Said Nasef Zedan, National Cancer Institute, Egypt

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11796
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Heavy Bupivacaine plus normal saline
2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline
Drug: Bupivacain
12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine
Other Names:
  • Spinal bupivacaine
Experimental: Heavy Bupivacaine plus dexmedetomidine
2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline
Drug: Bupivacain
12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine
Other Names:
  • Spinal bupivacaine
Drug: Dexmedetomidine
5 micrograms intrathecal dexmedetomidine
Other Names:
  • Spinal dexmedetomidine
Experimental: Heavy Bupivacaine plus midazolam
2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline
Drug: Bupivacain
12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine
Other Names:
  • Spinal bupivacaine
Drug: Midazolam
2 milligrams intrathecal midazolam
Other Names:
  • Spinal midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of sensory block
Time Frame: 12 hours
Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of vomiting occurrence
Time Frame: 12 hours
The patient will be reported in case of vomiting occurrence
12 hours
Sedation
Time Frame: 12 hours
Ramsay's sedation score1: anxious, agitated and restlessness, 2: oriented and cooperative, 3: responds to command only, 4: brisk response to loud voice and light glabellar tap, 5: sluggish to no response to light glabellar tap or loud auditory stimulus, 6: no response even to pain
12 hours
Change in mean arterial blood pressure
Time Frame: 12 hours
Non invasive blood pressure measurement
12 hours
Duration of motor block
Time Frame: 12 hours
Ability of patient to regain full motor power
12 hours
Change in heart rate
Time Frame: 12 hours
Heart rate will be compared between the three groups and will be compared with baseline preoperative values in each group
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Study Director: Mohamed Elwasef, MD, NCI Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

March 10, 2022

Study Completion (Actual)

March 10, 2022

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP210330102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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