Evaluation the effect of intrathecal midazolam in combination with fentanyl in strengthening analgesic effect in the lower limb surgery

Efficacy of intrathecal midazolam in strengthening the analgesic effect of intrathecal fentanyl in patients undergoing lower limb surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017030732923N1

Enrollment

Registered

2017-04-21

Start date

2016-09-21

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

Lower limb surgery. Surgical operation and other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Interventions

Intervention 1: First group: intravenous infusion of 3 cc of 0.5% marcaine plus 0.7 cc of 0.09% normal saline. Intervention 2: Second group: intravenous infusion of 3 cc of 0.5% marcaine plus 25 micro

Treatment - Drugs

First group: intravenous infusion of 3 cc of 0.5% marcaine plus 0.7 cc of 0.09% normal saline

Second group: intravenous infusion of 3 cc of 0.5% marcaine plus 25 micrograms phentanyl plus 0.2 cc 0.09% normal saline

Third group: intravenous infusion of 3 cc of 0.5% marcaine in combination with 25 micrograms phentanyl and 1 milligrams of midazolam

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Main inclusion criteria: age limitation 20-60 years; candidates of lower limb surgery with ASA PS I and II. Main exclusion criteria: contraindications to intrathecal analgesia; history of chronic pains; addiction; NSAID usage 12 hours prior to surgery.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Duration of sensory nerve block. Timepoint: Two houres, four houres, eight houres, 12 houres and 24 houres after surgery. Method of measurement: Sensory evaluation of patients with needle based on the time in minutes.;Duration of motor block. Timepoint: Two houres, four houres, eight houres, 12 houres and 24 houres after surgery. Method of measurement: Evaluation of lower extremity mobility through mbs2 based on the time in minutes.	—

Measure

Time frame

Duration of sensory nerve block. Timepoint: Two houres, four houres, eight houres, 12 houres and 24 houres after surgery. Method of measurement: Sensory evaluation of patients with needle based on the time in minutes.;Duration of motor block. Timepoint: Two houres, four houres, eight houres, 12 houres and 24 houres after surgery. Method of measurement: Evaluation of lower extremity mobility through mbs2 based on the time in minutes.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Davarpanah

Zahedan University of Medical Sciences

Dr.davarpanah@zaums.ac.ir00

Outcome results

None listed

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