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Effect of pregabalin on hemodynamic on pain

Effect of a single dose of Pregabalin on intraoperative hemodynamic changes and duration of analgesia in spinal anesthesia for tibial bone fracture orthopedic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014121020272N1
Enrollment
120
Registered
2015-08-24
Start date
2014-03-20
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

Spinal anesthesia. Unspecified adverse effect of drug or medicament

Interventions

Intervention 1: pregabalin group (150 mg capsule): because of 150 mg capsules it's not available on the market of Iran that is given two 75 mg capsules instead. A hour before spinal anesthesia is use
Treatment - Drugs
pregabalin group (150 mg capsule): because of 150 mg capsules it's not available on the market of Iran that is given two 75 mg capsules instead. A hour before spinal anesthesia is used by nurses in t
placebo group (Appearance, but no active ingredient drug capsules ). A hour before spinal anesthesia is used by nurses in the orthopedic unite, who was not aware of drugs the patient is given effect

Sponsors

Deputy for research Zahedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: The non-emergency patients ASA class 1; Age 20 to 70 years; candidates for orthopedic surgery tibia fracture; the prior written consent from patient; social class and level of consciousness that patient is able to cooperate ;    Exclusion criteria were the beginning of the study: hemodynamic status is affected with diseases or conditions such as heart disease, diabetes, renal ;The history of allergy to gabapentin or Pregabalin, drug use, regular use of alcohol or smoking more than 5 years, the diseases of the brain and nerves ; spinal anesthesia during surgery after more than ninety minutes ; patients who require drugs that affect hemodynamic ; pregnancy ; refusal of doing research and refusal of spinal anesthesia patients ; patients with coagulopathy ; infection in site of the spinal anesthesia ; any interference with the absorption of oral drugs that can cause digestive disorders ; The disease affects the feeling of pain, such as diabetes, drug addiction ; Monitor the patient is indicative of Abnormal pulse , mean arteria presure ; The need for analgesics for pain relief      Exclusion criteria during the study: Abnormal bleeding during surgery ; Intraoperative cardiovascular and brain complications ; Monitor the patient is indicative of abnormal pulse, mean arterial pressure.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mean arterial pressure? pulse. Timepoint: Thirty minutes before feeding capsules every ten minutes. Every ten minutes after spinal anesthesia to complete the surgery. Method of measurement: Monitoring of vital signs.;Duration of analgesia in spinal anesthesia. Timepoint: After the onset of anelgesia by spinal anesthesia Until the onset of pain. Method of measurement: Timer(minute).

Secondary

MeasureTime frame
No exist. Timepoint: No exist. Method of measurement: No exist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Moosavi

Zahedan University of Medical Sciences

amir.moosavi@zaums.ac.ir+98 54 3322 0501

Outcome results

None listed

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