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Comparison of the effect of adding dexmedetomidine or fentanyl to ropivacaine on sensory and motor characteristics and analgesia after orthopedic lower limb surgery

Comparison of Dexmedetomidine and Fentanyl as Adjuvant to intrathecal Ropivacaine in Lower Limb Orthopedic Procedures

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130311012782N41
Enrollment
90
Registered
2020-03-03
Start date
2020-04-02
Completion date
Unknown
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensory and motor nerve blocks.

Interventions

Intervention 1: Intervention group: injection of 4.5 ml ropivacaine% isobaric + 5 micg dexmedetomidine in 5 ml normal slain. Intervention 2: Intervention group: Injection of 4.5 ml of isobaric ropiva

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Weight less than 100 kg Patient undergoing lower extremity orthopedic surgery

Exclusion criteria

Exclusion criteria: Pregnancy History of addiction or smoking, drugs and alcohol liver disease cardiovascular disease Chronic pain report lasting more than 6 months Drug sensitivity or ropivacaine, fentanyl and dexmedetomidine contraindication of spinal anesthesia Long-term drug history or opioid and NSAIDs

Design outcomes

Primary

MeasureTime frame
Time to start sensory block. Timepoint: After the intrathecal injection of the anesthetic drug. Method of measurement: Sensory testing with no sensation of tingling with Nidel No. 23 is evaluated as subcutaneous stimulation.

Secondary

MeasureTime frame
Postoperative pain. Timepoint: Every 15 minutes in recovery and every 2 hour in ward. Method of measurement: With using visual Analog Scale. The criterion is a line between zero to ten and zero in the sense of no pain and ten being the most severe equivalent of the pain experienced by the patient. With this concept, the patient is asked to indicate their current pain intensity on line.;Blood pressure. Timepoint: Every 15 minutes during surgery and recovery. Method of measurement: Pulse Oximeter.;Heart rate. Timepoint: Every 15 minutes during surgery and recovery. Method of measurement: Pulse Oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamadjavad Hoseini

Esfahan University of Medical Sciences

mohammadjavadhosseini84@yahoo.com+98 31 3668 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026