Fentanyl Versus Midazolam as an Adjunct to Spinal Anesthesia

NCT06917898 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MGH-07-24001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

It is well documented in the practice of anesthesia the effectiveness of bupivacaine when added with other adjuvants including midazolam, opioids, and ketamine during neuraxial spinal block for cesarean delivery, however comparison of the superiority of midazolam 2mg over fentanyl 25 micrograms or vice versa with bupivacaine during cesarean delivery has not been established and if performed diligently, could potentially change our understanding and current practice for better patient outcomes.

Conditions

Healthy Female Volunteer

Keywords

Fentanyl; Midazolam; Obstetrical Anesthesia; Cesarean Section; Bupivacaine; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• rescue analgesia

  The primary outcome is the timing of the first analgesia requested postoperatively (i.e., the rescue analgesia).

  24 Hours

Study Arms (2)

Intrathecal Fentanyl

ACTIVE COMPARATOR

Drug: Spinal Anesthesia with Bupivacaine and Fentanyl

Intrathecal Midazolam

ACTIVE COMPARATOR

Drug: Spinal Anesthesia with Bupivacaine and Midazolam

Interventions

Spinal Anesthesia with Bupivacaine and Fentanyl DRUG

25 mcg Fentanyl 12.5 mg Bupivacaine

Intrathecal Fentanyl

Spinal Anesthesia with Bupivacaine and Midazolam DRUG

2 Mg Midazolam 12.5 mg Bupivacaine

Intrathecal Midazolam

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant female participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-45 with American Society of Anesthesia (ASA) class II will be included in the study.

You may not qualify if:

• patients with history of opioid substance abuse
• pre-eclampsia or eclampsia
• Gestational Hypertension
• uncontrolled diabetes mellitus
• significant cardiac, renal, and hepatic morbidity (i.e., ASA class III patients).

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon, 00000, Lebanon

Location

Related Publications (2)

• Khezri MB, Tahaei E, Atlasbaf AH. COMPARISON OF POSTOPERATIVE ANALGESIC EFFECT OF INTRATHECAL KETAMINE AND FENTANYL ADDED TO BUPIVACAINE IN PATIENTS UNDERGOING CESAREAN SECTION: A PROSPECTIVE RANDOMIZED DOUBLE-BLIND STUDY. Middle East J Anaesthesiol. 2016 Feb;23(4):427-36.

  PMID: 27382812 BACKGROUND

• Abdelrady MM, Fathy GM, Abdallah MAM, Ali WN. Comparison of the effect of adding midazolam versus fentanyl to intrathecal levobupivacaine in patients undergoing cesarean section: double-blind, randomized clinical trial. Braz J Anesthesiol. 2024 Jan-Feb;74(1):744385. doi: 10.1016/j.bjane.2022.06.001. Epub 2022 Jun 11.

  PMID: 35700752 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Anesthesia, Spinal; Bupivacaine; Fentanyl; Midazolam

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Anesthesia Department

Model Details: The study design implemented will be a Double-blinded, prospective randomized clinical trial at Makassed General Hospital comparing two groups, Group (M) for midazolam and Group (F) for fentanyl where both patients and physicians will be unaware (blinded) of which drug was used during the spinal neuraxial block. Patients aged 18-45 with American Society of Anesthesia (ASA) class II will be included in the study. Patients excluded from the clinical trial include those with contraindications to spinal anesthesia such as infection at injection site, bleeding coagulopathies with risk of spinal hematoma formation, and history of allergies to bupivacaine, opioids, or midazolam. Exclusion criteria also included patients with history of opioid substance abuse, pre-eclampsia or eclampsia, uncontrolled diabetes mellitus, and significant cardiac, renal, and hepatic morbidity (i.e., ASA class III patients).

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 9, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)