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NCT Number: NCT06917898

Fentanyl Versus Midazolam as an Adjunct to Spinal Anesthesia

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Makassed General Hospital

Beirut, Lebanon, 00000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Spinal Anesthesia with Bupivacaine and Fentanyl

Drug

25 mcg Fentanyl 12.5 mg Bupivacaine

Spinal Anesthesia with Bupivacaine and Midazolam

Drug

2 Mg Midazolam 12.5 mg Bupivacaine

Primary outcomes

  1. rescue analgesia

    Time frame: 24 Hours

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

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

Fentanyl Versus Midazolam During Spinal Block With Bupivacaine for Elective Cesarean Delivery: a Prospective Randomized Double-blind Clinical Trial.

Acronym: Spinal Block

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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