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Comparison of different doses of dexmedetomidine in lower limb orthopedic surgeries

Comparison of different intrathecal doses of Dexmedetomidine in terms of hemodynamic parameters and block quality after spinal anesthesia with Ropivacaine in lower limb orthopedic surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017070614056N12
Enrollment
81
Registered
2017-07-29
Start date
2017-05-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Postoperative pain. acute pain

Interventions

Intervention 1: The first group will receive 15 mg ropivacaine and 5 µg dexmedetomidine at a volume of 2 ml intrathecally. Intervention 2: The second group will receive 15 mg ropivacaine and 10 µg dex
Treatment - Drugs
Placebo
The first group will receive 15 mg ropivacaine and 5 µg dexmedetomidine at a volume of 2 ml intrathecally.
The second group will receive 15 mg ropivacaine and 10 µg dexmedetomidine at a volume of 2 ml intrathecally.
The third or control group will receive 15 mg ropivacaine and distilled water at a volume of 2 ml intrathecally.

Sponsors

Arak University of Medical Sciences,Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Candidate for lower limb orthopedic surgery under spinal anesthesia; Age between 18 to 60 years old; ASA class I and II. Exclusion criteria: Use of beta blockers, alpha-2 agonist and calcium channel blochers; Cardiovascular disease; Pregnancy; Coagulopathy; Local infection in the patient's caudal region; Allergy to dexmedetomidine or ropivacaine; History of psychiatric disorders; central or peripheral neuropathy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Postoperative pain. Timepoint: at 1, 2, 4, 6 and 12 hours after admission to recovery. Method of measurement: Visual analogue scale.;Mean arterial pressure. Timepoint: Every 15 min until the end of surgery. Method of measurement: sphygmomanometer.;Heart rate. Timepoint: Every 15 min until the end of surgery. Method of measurement: Cardiac monitoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hesameddin Modir

Arak University of Medical Sciences

dr.hemodir@arakmu.ac.ir+98 86 3313 9793

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 22, 2026