Comparison of the effect of Ropivacaine-Fentanyl and Ropivacaine-Sufentanil administration on spinal anesthesia

Comparison of the effect of administration of Ropivacaine-Fentanyl and Ropivacaine-Sufentanil combination on the characteristics of sensory and motor block in lower limb surgery under spinal anesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20081013001328N2

Enrollment

105

Registered

2022-09-06

Start date

2022-07-23

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

None listed

Interventions

Intervention 1: Intervention group A: Patients in this group are sedated with fentanyl prodrugs at a dose of 1 µg/kg and Midazolam at a dose of 20 µg/kg after monitoring and fluid therapy, and oxygen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years and above Candidate for lower limb surgery under spinal anesthesia ASA class I and II informed consent to enter the study

Exclusion criteria

Exclusion criteria: Infection at the injection site Coagulation disorders and the use of anticoagulants Suffering from high intracranial pressure Drug addiction Patients with body mass index (BMI) above 30

Design outcomes

Primary

Measure	Time frame
The time to onset of the numbing. Timepoint: Every 30 seconds from the moment of injection to the first feeling of numbing at the level of the L4 vertebra. Method of measurement: Pinprick and Timer.;Duration of reaching the maximum level of numbing. Timepoint: Every 30 seconds from the moment of injection to numbing of the T12 vertebra surface. Method of measurement: Pinprick and Timer.;Duration of return of numbing. Timepoint: From the time of drug injection until the return of sensation at S1 level. Method of measurement: Pinprick and Timer.	—

Measure

Time frame

The time to onset of the numbing. Timepoint: Every 30 seconds from the moment of injection to the first feeling of numbing at the level of the L4 vertebra. Method of measurement: Pinprick and Timer.;Duration of reaching the maximum level of numbing. Timepoint: Every 30 seconds from the moment of injection to numbing of the T12 vertebra surface. Method of measurement: Pinprick and Timer.;Duration of return of numbing. Timepoint: From the time of drug injection until the return of sensation at S1 level. Method of measurement: Pinprick and Timer.

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Secondary

Measure	Time frame
Blood Pressure. Timepoint: before the injection, 3, 5, and 10 minutes after the spinal and then every 15 minutes until the end of recovery. Method of measurement: Sphymomanmeter.;Heart Rate. Timepoint: before the injection, 3, 5, and 10 minutes after the spinal and then every 15 minutes until the end of recovery. Method of measurement: ECG monitoring.;Oxygen Saturation. Timepoint: From the moment of entering the operating room until the end of recovery. Method of measurement: Pulse Oximeter.	—

Measure

Time frame

Blood Pressure. Timepoint: before the injection, 3, 5, and 10 minutes after the spinal and then every 15 minutes until the end of recovery. Method of measurement: Sphymomanmeter.;Heart Rate. Timepoint: before the injection, 3, 5, and 10 minutes after the spinal and then every 15 minutes until the end of recovery. Method of measurement: ECG monitoring.;Oxygen Saturation. Timepoint: From the moment of entering the operating room until the end of recovery. Method of measurement: Pulse Oximeter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactEmad Khan ahmad

Esfahan University of Medical Sciences

Emad.khanahmad@yahoo.com+98 31 3662 0048

Outcome results