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Comparison of hemodynamic changes and patients satisfaction(analgesia) in patients undergoing prostate biopsy surgery with two methods of anesthesia Sedation and Saddle

Comparison of hemodynamic changes and patients satisfaction(analgesia) in patients undergoing prostate biopsy surgery with two methods of anesthesia Sedation and Saddle

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013102315136N1
Enrollment
120
Registered
2013-11-08
Start date
2014-02-04
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

Pain during Prostate biopsy. Pelvic and perineal pain

Interventions

Intervention 1: Group "one" 5-10 minutes before biopsy will receive one dose 1 mcg /kg Intravenous Fentanyl and one dose 0.05 mg/kg Intravenous Midazolam for Sedation. Intervention 2: Group "two" Sadd
Treatment - Drugs
Group "one" 5-10 minutes before biopsy will receive one dose 1 mcg /kg Intravenous Fentanyl and one dose 0.05 mg/kg Intravenous Midazolam for Sedation.
Group "two" Saddle anesthesia with one dose 12 mg of hyperbaric bupivacaine will perform for patients in the sitting position at L3-L4 interspace using a 25-gauge Whitacre needle.

Sponsors

Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: the patient's complete satisfaction; -ASA class I & II and age between 20-50 years old . Exclusion criteria: contraindications of Saddle Anesthesia( patient refusal; infection at the site of planned needle puncture; elevated intracranial pressure); allergy or contraindication to any of the drugs used in the study; severe cardiovascular, respiratory, metabolic, or neurologic diseases.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hemodynamic Changes. Timepoint: End of Biopsy, 10, and 20 minutes after surgery. Method of measurement: Blood Pressure Measurement.

Secondary

MeasureTime frame
Patient Satisfaction of Pain Control. Timepoint: End of Biopsy, 10, and 20 minutes after surgery. Method of measurement: Visual Analoge Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Sahraeian

Ahvaz Jundishapur University of Medical Sciences

fatahi.m@ajums.ac.ir mostafafatahi777@gmail.com+98 61 1432 5879

Outcome results

None listed

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