Anesthesia, ObstetricNCT06055101
Regional Anaesthesia
A study testing DEXMEDETOMIDINE, Neostigmine and Bupivacaine in people with Anesthesia, Obstetric, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
Trial summary
Spinal anesthesia is an established technique used in obstetric surgeries, It provides adequate analgesia both intra and post-operative and also avoids complications associated with general anesthesia for mother and fetus. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anesthesia, Obstetric
- What is being tested?
- DEXMEDETOMIDINE, Neostigmine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2019to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I and II patients
- Age: 18 - 40 years
- Height 150 - 170 cm
- Weight 70 - 110 kg.
Who cannot join
- Patient refusal
- Cardiac diseases as ( ischemic heart disease, severe valvular stenosis, pulmonary hypertension, uncontrolled arrhythmias )
- Severe labile hypertension BP more than 160 / 100 )
- Raised intracranial pressure or pre-existing neurological disorders, such as multiple sclerosis.
- Patients with coagulopathy: platelets < 100,000 INR ≥ 1.3 or therapeutic use of anti-coagulants.
- Inability to communicate and understand the aim of the project.
Show all 9Show fewer
- Patients with history of allergic reaction to LA, DXM or Neostigmine.
- Skin infection at injection site or systemic bacteremia.
- Failure of the block and need for general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Bupivacaine-Dexmedetomidine Compared to Intrathecal Bupivacaine-Neostigmine in Elective Caesarean Sections, Randomized Clinical Trial
Spinal anesthesia is an established technique used in obstetric surgeries, It provides adequate analgesia both intra and post-operative and also avoids complications associated with general anesthesia for mother and fetus. The quality of spinal anesthesia has been reported to be improved by using additives Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been introduced to anesthesia. It produces dose-dependent sedation, anxiolysis, and analgesia without respiratory depression. Neostigmine is an anticholinesterase agent, which inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetyl cholinesterase; administration of Neostigmine through intrathecal route apparently activates the descending pain inhibitory system that relies on spinal cholinergic interneuron. Study conducted to evaluate whether neostigmine given by intrathecal route with 0.5% hyperbaric bupivacaine for spinal anesthesia can provide prolongation of sensory blockade duration as effective as dexmedetomidine given by the same route and in compination with same drug with lower cost, more stable hemodynamics and comparable side effects. After obtaining Institutional Ethics Committee approval and written informed consent,54 patients American Society of Anesthesiologist (ASA) physical status I and II were enrolled into the study and were randomlyassigned into 3 groups. Group 1were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (10 μg) DXM and 0.1 ml normal saline, Group 2 were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (50 μg) neostigmine and 0.1 ml normal saline and Group 3were received 10 mg (2ml) hyperbaric bupivacaine and 0.2 ml normal saline as control.
The investigators measured the time to reach T4 dermatome sensory block, peak sensory level, Time to reach Bromage 3 motor block, the regression time for sensory and motor block, also the investigators measured hemodynamic, sedation score, visual analogue score, any complications occurred and Apgar score for fetus during blockade and the investigators assessed the duration of pain relief .
- Conditions
- Anesthesia, Obstetric
- Being tested
- DEXMEDETOMIDINE, Neostigmine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXMEDETOMIDINEDrug
DXM is a nonselective α2 agonist. Alpha2 adrenoreceptors, the overall response to α2 adrenoreceptors agonists is related to the stimulation of α2 adrenoreceptors located in the CNS and spinal cord. These receptors are involved in the sympatholysis, sedation, and antinociception effects of α2 adrenoreceptors.
DEXMEDETOMIDINE (DXM) DXM shows a high ratio of specificity for the α2 receptor (α2/α11600: 1) compared with clonidine (α2/α1 200: 1), making it a complete α2 agonist. (76) DXM belongs to the imidazole subclass of α2 receptor agonists, similar to clonidine. It is freely soluble in water.
NeostigmineDrug
Neostigmine is an indirect cholinomimetic agent. It produces its primary effects by inhibiting the action of AChe, which hydrolyzes acetylcholine (ACh) to choline and acetic acid. By inhibiting AChe, the indirect-acting drug increases the concentration of spinal endogenous ACh. This drug is, in effect, amplifiers of endogenous ACh and act primarily where ACh is physiologically release. It combines reversibly with AChe by the formation of an ester linkage, which lasts about 30 minutes. The pharmacokinetic of neostigmine administered by bolus injection is linear with respect to bolus injection.
BupivacaineDrug
The onset of sensory blockade following spinal block with bupivacaine is very rapid (within one minute); maximum motor blockade and maximum dermatome level are achieved within 15 minutes in most cases.
The conduction of nerve impulses along nerve fibers is related to changes in the electrical gradient across the nerve membrane and movement of predominantly sodium ions (but also potassium ions) from intracellular to extracellular fluid and vice versa. Bupivacaine work by reversibly blocking specific areas of the nerve cell membrane, known as sodium channels. It contains a mixture of ionized and un-ionized particles which, when injected into body tissues, make more un-ionized particles available, which are lipid soluble and able to penetrate the nerve cell membrane.
| Study group | Role | What they receive |
|---|---|---|
| DEXMEDETOMIDINE | Other | Group 1 ( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (10 μg) DXM and 0.1 ml normal saline. Receives: Drug: DEXMEDETOMIDINE |
| Neostigmine | Other | Group 2( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (50 μg) neostigmine and 0.1 ml normal saline. Receives: Drug: Neostigmine |
| Bupivacaine | Other | Group 3 ( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.2 ml normal saline as control. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time started from the end of intrathecal injection till achievement of a bilateral sensory block at T10
assessed by a pin prick needle from caudal to cephalic direction
Measured: 90 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start3 Jan 2019
- Primary completion6 Mar 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, ObstetricStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Ali Abdelhaleem Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055101
- Sponsor's protocol ID
- AA-2023
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Bupivacaine-Dexmedetomidine Compared to Intrathecal Bupivacaine-Neostigmine in Elective Caesarean Sections, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06055101
- Acronym / sponsor ID
- AA-2023
- Conditions
- Anesthesia, Obstetric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Reham Ali Abdelhaleem AbdelrahmanUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 26 Sep 2023 (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.
Spinal anesthesia is an established technique used in obstetric surgeries, It provides adequate analgesia both intra and post-operative and also avoids complications associated with general anesthesia for mother and fetus. The quality of spinal anesthesia has been reported to be improved by using additives Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been introduced to anesthesia. It produces dose-dependent sedation, anxiolysis, and analgesia without respiratory depression. Neostigmine is an anticholinesterase agent, which inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetyl cholinesterase; administration of Neostigmine through intrathecal route apparently activates the descending pain inhibitory system that relies on spinal cholinergic interneuron. Study conducted to evaluate whether neostigmine given by intrathecal route with 0.5% hyperbaric bupivacaine for spinal anesthesia can provide prolongation of sensory blockade duration as effective as dexmedetomidine given by the same route and in compination with same drug with lower cost, more stable hemodynamics and comparable side effects. After obtaining Institutional Ethics Committee approval and written informed consent,54 patients American Society of Anesthesiologist (ASA) physical status I and II were enrolled into the study and were randomlyassigned into 3 groups. Group 1were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (10 μg) DXM and 0.1 ml normal saline, Group 2 were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (50 μg) neostigmine and 0.1 ml normal saline and Group 3were received 10 mg (2ml) hyperbaric bupivacaine and 0.2 ml normal saline as control.
The investigators measured the time to reach T4 dermatome sensory block, peak sensory level, Time to reach Bromage 3 motor block, the regression time for sensory and motor block, also the investigators measured hemodynamic, sedation score, visual analogue score, any complications occurred and Apgar score for fetus during blockade and the investigators assessed the duration of pain relief .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DEXMEDETOMIDINE | Other | Drug: DEXMEDETOMIDINEGroup 1 ( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (10 μg) DXM and 0.1 ml normal saline. |
| Neostigmine | Other | Drug: NeostigmineGroup 2( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (50 μg) neostigmine and 0.1 ml normal saline. |
| Bupivacaine | Other | Drug: BupivacaineGroup 3 ( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.2 ml normal saline as control. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I and II patients
- Age: 18 - 40 years
- Height 150 - 170 cm
- Weight 70 - 110 kg.
Key exclusion criteria (9 listed)
- Patient refusal
- Cardiac diseases as ( ischemic heart disease, severe valvular stenosis, pulmonary hypertension, uncontrolled arrhythmias )
- Severe labile hypertension BP more than 160 / 100 )
- Raised intracranial pressure or pre-existing neurological disorders, such as multiple sclerosis.
- Patients with coagulopathy: platelets < 100,000 INR ≥ 1.3 or therapeutic use of anti-coagulants.
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 |
|---|---|---|
| DEXMEDETOMIDINEDXM is a nonselective α2 agonist. Alpha2 adrenoreceptors, the overall response to α2 adrenoreceptors agonists is related to the stimulation of α2 adrenoreceptors located in the CNS and spinal cord. These receptors are involved in the sympatholysis, sedation, and antinociception effects of α2 adrenoreceptors. DEXMEDETOMIDINE (DXM) DXM shows a high ratio of specificity for the α2 receptor (α2/α11600: 1) compared with clonidine (α2/α1 200: 1), making it a complete α2 agonist. (76) DXM belongs to the imidazole subclass of α2 receptor agonists, similar to clonidine. It is freely soluble in water. | Drug | DEXMEDETOMIDINE |
| NeostigmineNeostigmine is an indirect cholinomimetic agent. It produces its primary effects by inhibiting the action of AChe, which hydrolyzes acetylcholine (ACh) to choline and acetic acid. By inhibiting AChe, the indirect-acting drug increases the concentration of spinal endogenous ACh. This drug is, in effect, amplifiers of endogenous ACh and act primarily where ACh is physiologically release. It combines reversibly with AChe by the formation of an ester linkage, which lasts about 30 minutes. The pharmacokinetic of neostigmine administered by bolus injection is linear with respect to bolus injection. | Drug | Neostigmine |
| BupivacaineThe onset of sensory blockade following spinal block with bupivacaine is very rapid (within one minute); maximum motor blockade and maximum dermatome level are achieved within 15 minutes in most cases. The conduction of nerve impulses along nerve fibers is related to changes in the electrical gradient across the nerve membrane and movement of predominantly sodium ions (but also potassium ions) from intracellular to extracellular fluid and vice versa. Bupivacaine work by reversibly blocking specific areas of the nerve cell membrane, known as sodium channels. It contains a mixture of ionized and un-ionized particles which, when injected into body tissues, make more un-ionized particles available, which are lipid soluble and able to penetrate the nerve cell membrane. | Drug | Bupivacaine |
Primary outcome
Time started from the end of intrathecal injection till achievement of a bilateral sensory block at T10
Time frame: 90 seconds
assessed by a pin prick needle from caudal to cephalic direction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
Related trials for Anesthesia, Obstetric
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruitingObservational study
ULTRASOUND ASSESSMENT OF GASTRİC VOLUME IN PREGNANT WOMEN UNDERGOİNG ELECTİVE CESAREAN SECTİON, WITH AND WITHOUT GESTATİONAL DIABETES MELLITUS
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingObservational study
Inertial Sensors for Obstetrical Walking Epidural Tracking
Pregnancy Related, Epidural; Anesthesia, Headache
Not yet recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Recruiting
Simulation-Based Training for Epidural Analgesia Placement
Epidural Analgesia, Medical Education
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 study testing DEXMEDETOMIDINE, Neostigmine and Bupivacaine in people with Anesthesia, Obstetric, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 26 Sep 2023. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time started from the end of intrathecal injection till achievement of a bilateral sensory block at T10 (time frame: 90 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023; AzTrials last refreshed its copy on 27 Oct 2026.