Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section

Mohamed Abdelrady Mohamed

Status and phase: Completed; Phase 1

Conditions: Cesarean Section Complications

Treatments: Drug: Fentanyl; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03824314

midazolam versus fentanyl

Details and patient eligibility

About

The aim of this study is to compare the effects of intrathecal levobupivacaine plus midazolam and levobupivacaine plus fentanyl in patients undergoing caesarean section to get a prolonged postoperative analgesic effect and less side effects

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients of American Society of Anaesthesiologists grades I and II ,

Exclusion criteria

• pre-existing neurological or spinal disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group M

Experimental group

Description:

. Group M (n = 40) receive 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg) ) intrathecally

Treatment:

Drug: Midazolam

group F

Experimental group

Description:

group F (n = 40) receive 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml fentanyl (25 μg) intrathecally. Under all aseptic precautions, spinal anaesthesia will be given in L3 and L4 space with 25 gauge Quincke spinal needle via midline approach in sitting position. On free flow of cerebrospinal fluid, study drug will be injected intrathecally . Patients will immediately turn to supine position

Treatment:

Drug: Fentanyl