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

• ClinicalTrials.gov Identifier: NCT03824314
• Recruitment Status: Completed
• First Posted: January 31, 2019
• Last Update Posted: July 14, 2020
• Sponsor: Mohamed Abdelrady Mohamed
• Information provided by (Responsible Party): Mohamed Abdelrady Mohamed, Assiut University

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Cesarean Section Complications	Drug: Midazolam; Drug: Fentanyl	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Comparison of the Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: February 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group M; . Group M (n = 40) receive 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg) ) intrathecally	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
Experimental: group F; 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	Drug: 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

Outcome Measures

Primary Outcome Measures :

1. 1st post-operative analgesic request [ Time Frame: 24-hour ]
   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.

Secondary Outcome Measures :

1. duration of sensory block Total analgesic consumption [ Time Frame: 24-hour ]
   total duration of sensory block (regression to S1 dermatome) will be noted

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• pre-existing neurological or spinal disease

Contacts and Locations

Locations

Egypt

Mohamed

Assiut, Egypt, 71511

Sponsors and Collaborators

Mohamed Abdelrady Mohamed

More Information

• Responsible Party: Mohamed Abdelrady Mohamed, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03824314
• Other Study ID Numbers: midazolam versus fentanyl
• First Posted: January 31, 2019
• Last Update Posted: July 14, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fentanyl; Midazolam; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action