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Completed

NCT Number: NCT06315634

Intrathecal Dexmedetomidine vs Midazolame

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National cancer institute

Cairo, 11796, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

5 micrograms intrathecal dexmedetomidine

Other names: Spinal dexmedetomidine

midazolam

Drug

2 milligrams intrathecal midazolam

Other names: Spinal midazolam

Bupivacain

Drug

12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine

Other names: Spinal bupivacaine

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of vomiting occurrence

    Time frame: 12 hours

    The patient will be reported in case of vomiting occurrence

  2. 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

  3. Change in mean arterial blood pressure

    Time frame: 12 hours

    Non invasive blood pressure measurement

  4. Duration of motor block

    Time frame: 12 hours

    Ability of patient to regain full motor power

  5. 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

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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