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Analgesic Effect of Adding Midazolam and Fentanyl to Intrathecal Bupivacaine 0.05%

Analgesic Effect of Adding Midazolam and Fentanyl to Intrathecal Bupivacaine 0.05% in Patients with Orthopedic Surgery of Lower Limbs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014061810340N9
Enrollment
75
Registered
2016-09-25
Start date
2015-10-17
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. Pain in limb

Interventions

Intervention 1: 15 mg of bupivacaine 0.5% (3 cc) with 0.5 mg of midazolam. Intervention 2: 15 mg of bupivacaine 0.5% (3 cc) with fentanyl 25 microgram (µg). Intervention 3: 15 milligram (mg) of bupiva
Placebo
15 mg of bupivacaine 0.5% (3 cc) with 0.5 mg of midazolam
15 mg of bupivacaine 0.5% (3 cc) with fentanyl 25 microgram (µg)
15 milligram (mg) of bupivacaine 0.5% (equivalent to 3 cc) with 0.5 milliliter (ml) of normal saline

Sponsors

Golestan University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: people aged 18-65 years that categorized into class 1 and 2 based on America Society of Anesthesiologists (ASA); Exclusion criteria : rejection of patients with substance abuse, patients with symptoms of neuropathy, and lack of appropriate sensory level after performing the spinal anesthesia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Duration of analgesia. Timepoint: After intervention. Method of measurement: Duration of analgesia.

Secondary

MeasureTime frame
Hemodynamic Change. Timepoint: Before Intervention, 30 ,60 and 90 minutes after intervention. Method of measurement: Sphygmomanometer, Pols oximeter.;Chills. Timepoint: After intervention. Method of measurement: Observation.;Nausea. Timepoint: After intervention. Method of measurement: Observation.;Vomiting. Timepoint: After intervention. Method of measurement: Observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHomeira Khodam

Golestan University of Medical Science

homeira_khoddam@yahoo.com+98 17 3242 4377

Outcome results

None listed

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