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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824314
• Other study ID #: midazolam versus fentanyl
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pre-existing neurological or spinal disease

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Midazolam
2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg)will be given intrathecally 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
• Fentanyl
2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml fentanyl (25 µg)will be given intrathecally 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

Locations

Country	Name	City	State
Egypt	Mohamed	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Abdelrady Mohamed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1st post-operative analgesic request	pain will be evaluated using VAS score, every 30 min for 180 min then hourly for 12 h and thereafter every 3 hourly till 24 h of surgery in both groups. Rescue analgesia in the form of injection Ketorolac 30mg I.V when VAS >3 in both groups.	24-hour
Secondary	duration of sensory block Total analgesic consumption	total duration of sensory block (regression to S1 dermatome) will be noted	24-hour