Healthy Female VolunteerPhase 1Spinal BlockNCT06917898
Fentanyl Versus Midazolam as an Adjunct to Spinal Anesthesia
A Phase 1 study testing Spinal Anesthesia with Bupivacaine and Fentanyl and Spinal Anesthesia with Bupivacaine and Midazolam in people with Healthy Female Volunteer, run by Makassed General Hospital at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Female Volunteer
- What is being tested?
- Spinal Anesthesia with Bupivacaine and Fentanyl and Spinal Anesthesia with Bupivacaine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Apr 2025to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-45 with American Society of Anesthesia (ASA) class II will be included in the study.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fentanyl Versus Midazolam During Spinal Block With Bupivacaine for Elective Cesarean Delivery: a Prospective Randomized Double-blind Clinical Trial.
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.
Read the 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.
- Conditions
- Healthy Female Volunteer
- Being tested
- Spinal Anesthesia with Bupivacaine and Fentanyl, Spinal Anesthesia with Bupivacaine and Midazolam
- Keywords
- Fentanyl, Midazolam, Obstetrical Anesthesia, Cesarean Section, Bupivacaine, Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia with Bupivacaine and FentanylDrug
25 mcg Fentanyl 12.5 mg Bupivacaine
Spinal Anesthesia with Bupivacaine and MidazolamDrug
2 Mg Midazolam 12.5 mg Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Fentanyl | Active comparator | Not described Receives: Drug: Spinal Anesthesia with Bupivacaine and Fentanyl |
| Intrathecal Midazolam | Active comparator | Not described Receives: Drug: Spinal Anesthesia with Bupivacaine and Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
rescue analgesia
The primary outcome is the timing of the first analgesia requested postoperatively (i.e., the rescue analgesia).
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Apr 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Female VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Rajab, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917898
- Sponsor's protocol ID
- MGH-07-24001
- Acronym
- Spinal Block
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27382812Abdelrady 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.
PubMed 35700752
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Versus Midazolam During Spinal Block With Bupivacaine for Elective Cesarean Delivery: a Prospective Randomized Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT06917898
- Acronym / sponsor ID
- Spinal Block / MGH-07-24001
- Conditions
- Healthy Female Volunteer
- Keywords
- Fentanyl, Midazolam, Obstetrical Anesthesia, Cesarean Section, Bupivacaine, Spinal Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Fentanyl | Active comparator | Drug: Spinal Anesthesia with Bupivacaine and Fentanyl |
| Intrathecal Midazolam | Active comparator | Drug: Spinal Anesthesia with Bupivacaine and Midazolam |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-45 with American Society of Anesthesia (ASA) class II will be included in the study.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Anesthesia with Bupivacaine and Fentanyl25 mcg Fentanyl 12.5 mg Bupivacaine | Drug | Intrathecal Fentanyl |
| Spinal Anesthesia with Bupivacaine and Midazolam2 Mg Midazolam 12.5 mg Bupivacaine | Drug | Intrathecal Midazolam |
Primary outcome
rescue analgesia
Time frame: 24 Hours
The primary outcome is the timing of the first analgesia requested postoperatively (i.e., the rescue analgesia).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Results publication: PubMed 27382812Khezri 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.
- Results publication: PubMed 35700752Abdelrady 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spinal Anesthesia with Bupivacaine and Fentanyl and Spinal Anesthesia with Bupivacaine and Midazolam in people with Healthy Female Volunteer, run by Makassed General Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rescue analgesia (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917898, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.