Healthy Female Volunteer
Conditions
Keywords
Fentanyl, Midazolam, Obstetrical Anesthesia, Cesarean Section, Bupivacaine, Spinal Anesthesia
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.
Detailed description
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.
Interventions
25 mcg Fentanyl 12.5 mg Bupivacaine
DRUGSpinal Anesthesia with Bupivacaine and Midazolam
2 Mg Midazolam 12.5 mg Bupivacaine
Sponsors
Makassed General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rescue analgesia | 24 Hours | The primary outcome is the timing of the first analgesia requested postoperatively (i.e., the rescue analgesia). |
Countries
Lebanon
Outcome results
None listed