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Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery

ConditionsIntrathecal DexmedetomidineBupivacaineKnee Orthopedic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this trial

This study aims to compare the duration of analgesia (as the primary outcome) and adverse effects (as the secondary outcome) after intrathecal administration of dexmedetomidine with hyperbaric bupivacaine to patients undergoing knee orthopedic surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 65 years.

American Society of Anesthesiologists (ASA) physical status I-II.

Male patients scheduled for knee orthopedic surgery.

Disqualifiers

Patients with psychiatric disorders.

History of drug addiction.

Contraindication for regional anesthesia.

History of hypersensitivity to the study drugs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine 4 μg

    Drug

    Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg.

  • Dexmedetomidine 8 μg

    Drug

    Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg.

  • Dexmedetomidine 12 μg

    Drug

    Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Group IExperimental treatment 1 intervention
Group B: Group IIExperimental treatment 1 intervention
Group C: Group IIIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to request rescue analgesia

Time to request rescue analgesia will be recorded from the end of surgery to the first dose of morphine administrated

Time frame
24 hours postoperatively

Secondary outcomes

1

Heart rate

Heart rate will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.

Time frame
In the recovery room (Up to 2 hours)
2

Mean arterial blood pressure

Mean arterial blood pressure will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.

Time frame
In the recovery room (Up to 2 hours)
3

Respiratory rate

Respiratory rate will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.

Time frame
In the recovery room (Up to 2 hours)
4

Oxygen saturation

Oxygen saturation will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.

Time frame
In the recovery room (Up to 2 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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