Fentanyl Versus Midazolam as an Adjunct to Spinal Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery

NCT06985992

Caesarean Section

NOT_YET_RECRUITING NA

Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section

NCT02937792

Spinal Anesthesia

UNKNOWN NA

Low-Doses Of Isobaric Bupivacaine On Intraoperative Hemodynamics In Spinal Anesthesia During Cesarean Section

NCT05136040

Cesarean Section Hemodynamic Instability

COMPLETED NA

Intrathecal Nalbuphine Versus Midazolam in Cesarean Section

NCT03918187

Cesarean Section Pain

COMPLETED PHASE1

Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section

NCT04464616

Postoperative Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A study published on Jan - Feb 2024 has compared adjuvants fentanyl 25 micrograms and midazolam 2mg when added to Levobupivacaine for patients undergoing cesarean section with Midazolam being the superior drug of choice with less side effects. \[1\] Another study done around our locality at the American University of Beirut compared the postoperative analgesic effect of ketamine and fentanyl when added to bupivacaine in patients undergoing cesarean section with results conclusive of equally effective post cesarean pain control. \[2\] One study compared intrathecal midazolam 2mg with intrathecal fentanyl 12.5 micrograms with bupivacaine \[3\], and results elucidated equal surgical analgesia during the operation in contrast to the superior Midazolam 2mg vs the intrathecal fentanyl 25 micrograms when added to levobupivacaine mentioned in the first study. Current literature is void of studies comparing intrathecal fentanyl 25 micrograms vs intrathecal midazolam 2mg when added to bupivacaine for cesarean delivery.

Study objectives:

Comparative studies are available for different adjuvants when administered along with bupivacaine or levobupivacaine, but the specific aim and target of this study is to compare Hyperbaric Bupivacaine 0.5% 12.5 mg with fentanyl 25 micrograms (2 ml) versus Hyperbaric Bupivacaine 0.5% 12.5 mg with midazolam 2mg (2 ml) for cesarean delivery.

Levobupivacaine is not as readily available as bupivacaine in our population. Opioids have significantly more side effects when administered intrathecally including pruritus, respiratory depression, post operatively nausea and vomiting, and any attempt to decrease their usage to improve patient satisfaction without compromising the overall analgesic effect should be pursued. The results from this study could potentially change current practice in our hospital and across local and national areas respectively.

This study aims to provide conclusive data about the superiority of midazolam in reduction of postoperative pain, reduction of postoperative rescue analgesia, the quality of sensory block, and the reduction in side effects when administered with Bupivacaine as opposed to Levobupivacaine which was demonstrated in the study \[1\] mentioned above.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Female Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intrathecal Fentanyl

Group Type ACTIVE_COMPARATOR

Spinal Anesthesia with Bupivacaine and Fentanyl

Intervention Type DRUG

25 mcg Fentanyl 12.5 mg Bupivacaine

Intrathecal Midazolam

Group Type ACTIVE_COMPARATOR

Spinal Anesthesia with Bupivacaine and Midazolam

Intervention Type DRUG

2 Mg Midazolam 12.5 mg Bupivacaine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spinal Anesthesia with Bupivacaine and Fentanyl

25 mcg Fentanyl 12.5 mg Bupivacaine

Intervention Type DRUG

Spinal Anesthesia with Bupivacaine and Midazolam

2 Mg Midazolam 12.5 mg Bupivacaine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes