Spinal Anesthetics Causing Adverse Effects in Therapeutic UsePhase 2/3NCT06654531
Effect of Intravenous or Intrathecal Dexmedetomidine on Bupivacaine Spinal Block in Lower Abdominal Surgery
A Phase 2/3 study testing Dexmedetomidine in people with Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study is a comparative study will be carried out after approval by the Local Ethical Committee in Al-Azhar University hospital (Assiut) and after obtaining patients' written informed consent. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2022to 10 Mar 2024
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I-II
- lower abdominal surgery
- Aged 20-60 years of both sexes
Who cannot join
- Patient refusal.
- history of cardiac, hepatic, neurological, or renal disease.
- BMI ≥30kg/ m2 (Morbid obesity).
- Patients with diabetes mellitus.
- history of allergy to study drugs, any contraindication for regional anesthesia
- Coagulopathy.
- failed or unsatisfactory spinal block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between the Effect of Intravenous or Intrathecal Dexmedetomidine on Bupivacaine Spinal Block
This study is a comparative study will be carried out after approval by the Local Ethical Committee in Al-Azhar University hospital (Assiut) and after obtaining patients' written informed consent.
50 ASA physical status I-II aged 20-60 years of both sexes scheduled for lower abdominal surgery with an expected duration of 90-120 min under spinal anesthesia will be enrolled in this study
Read more
Primary outcome :
- The onset and duration of sensory and motor blockade ,Postoperative analgesic efficacy .
Secondary outcomes :
- to assess the effect on hemodynamics and postoperative analgesic requirement All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine (Marcaine 0.5%; Astra Zeneca, UK) together with 5 μg Dexmedetomidine (Precedex; Abbott; Chicago, IL, USA, 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.
Read the detailed description
Neuraxial anesthesia and analgesia provide a solid analgesic effect by inhibiting nociceptive transmission from peripheral to the central neuronal system . However, their analgesic advantages might be limited by the short life of current local anesthetics (LAs). Therefore, adjunct analgesic strategy is an alternative to prolonging the analgesic duration and decreases the potential risk of side effects by reducing the dose of LA.
This study is a comparative study will be carried out after approval by the Local Ethical Committee in Al-Azhar University hospital (Assiut) and after obtaining patients' written informed consent. inclusion criteria will be: 50 ASA physical status I-II aged 20-60 years of both sexes scheduled for lower abdominal surgery with an expected duration of 90-120 min under spinal anesthesia will be enrolled in this study. Exclusion criteria
- Patient refusal.
- history of cardiac, hepatic, neurological, or renal disease.
- BMI ≥30kg/ m2 (Morbid obesity).
- Patients with diabetes mellitus.
- history of allergy to study drugs, any contraindication for regional anesthesia
- Coagulopathy.
- failed or unsatisfactory spinal block. Study tools All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Under a sterile technique, spinal anesthesia will be carried out using a 22-G Quincke spinal needle after skin infiltration with 2% lidocaine 3 ml a t the L3-L4 level, a midline approach in the sitting position, and then in the supine position.
Th e time of spinal injection will be considered time zero (T0). The I.V drug regimen will be started according to the group to which patients will be assigned.patients will receive intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine in group 2
| Study group | Role | What they receive |
|---|---|---|
| group 1 (I.V group ) | Active comparator | Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. Receives: Drug: Dexmedetomidine |
| group 2 (intrathecal group) | Active comparator | 25 patients received intrathecal 15 mg hyperbaric bupivacaine (Marcaine 0.5%; Astra Zeneca, UK) together with 5 μg Dexmedetomidine (Precedex; Abbott; Chicago, IL, USA, 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic efficacy
duration of sensory blockade of spinal anaesthesia
Measured: 15 minutes intervals for 12 hours postoperatively
Postoperative analgesic efficacy
duration of motor blockade of spinal anesthesia
Measured: 20 minutes intervals for 12 hours postoperatively
Secondary outcomes (4)
Haemodynamics
heart rate
Measured: 1 hours intervals from start of operation until 12 hours postoperatively
Assessment of pain
NRS 0-10 (0 = no pain, 10 = the worst pain imaginable)
Measured: every 1 hour intervals until 12 hours postoperatively
Assessment of sedation
Ramsay sedation scale
Measured: every 30 minutes intervals for 12 hours postoperatively
hemodynamics
Mean blood pressure
Measured: 1 hours intervals from start of operation until 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start2 Jan 2022
- Primary completion30 Dec 2023
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthetics Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed abed mansour, Al-Azhar University
- Investigators
- ezzat m ali el soudy, professor, Study chair, professor of anaesthesia and icu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654531
- Sponsor's protocol ID
- 66
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: analytical data will be available
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Intravenous or Intrathecal Dexmedetomidine on Bupivacaine Spinal Block
- ClinicalTrials.gov ID
- NCT06654531
- Acronym / sponsor ID
- 66
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 23 Oct 2024 (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.
This study is a comparative study will be carried out after approval by the Local Ethical Committee in Al-Azhar University hospital (Assiut) and after obtaining patients' written informed consent.
50 ASA physical status I-II aged 20-60 years of both sexes scheduled for lower abdominal surgery with an expected duration of 90-120 min under spinal anesthesia will be enrolled in this study
Primary outcome :
- The onset and duration of sensory and motor blockade ,Postoperative analgesic efficacy .
Secondary outcomes :
- to assess the effect on hemodynamics and postoperative analgesic requirement All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine (Marcaine 0.5%; Astra Zeneca, UK) together with 5 μg Dexmedetomidine (Precedex; Abbott; Chicago, IL, USA, 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.
Detailed description
Neuraxial anesthesia and analgesia provide a solid analgesic effect by inhibiting nociceptive transmission from peripheral to the central neuronal system . However, their analgesic advantages might be limited by the short life of current local anesthetics (LAs). Therefore, adjunct analgesic strategy is an alternative to prolonging the analgesic duration and decreases the potential risk of side effects by reducing the dose of LA.
This study is a comparative study will be carried out after approval by the Local Ethical Committee in Al-Azhar University hospital (Assiut) and after obtaining patients' written informed consent. inclusion criteria will be: 50 ASA physical status I-II aged 20-60 years of both sexes scheduled for lower abdominal surgery with an expected duration of 90-120 min under spinal anesthesia will be enrolled in this study. Exclusion criteria
- Patient refusal.
- history of cardiac, hepatic, neurological, or renal disease.
- BMI ≥30kg/ m2 (Morbid obesity).
- Patients with diabetes mellitus.
- history of allergy to study drugs, any contraindication for regional anesthesia
- Coagulopathy.
- failed or unsatisfactory spinal block. Study tools All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.
| Arm | Type | Receives |
|---|---|---|
| group 1 (I.V group ) | Active comparator | Drug: DexmedetomidinePatients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. |
| group 2 (intrathecal group) | Active comparator | Drug: Dexmedetomidine25 patients received intrathecal 15 mg hyperbaric bupivacaine (Marcaine 0.5%; Astra Zeneca, UK) together with 5 μg Dexmedetomidine (Precedex; Abbott; Chicago, IL, USA, 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I-II
- lower abdominal surgery
- Aged 20-60 years of both sexes
Key exclusion criteria (7 listed)
- Patient refusal.
- history of cardiac, hepatic, neurological, or renal disease.
- BMI ≥30kg/ m2 (Morbid obesity).
- Patients with diabetes mellitus.
- history of allergy to study drugs, any contraindication for regional anesthesia
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 |
|---|---|---|
| DexmedetomidineUnder a sterile technique, spinal anesthesia will be carried out using a 22-G Quincke spinal needle after skin infiltration with 2% lidocaine 3 ml a t the L3-L4 level, a midline approach in the sitting position, and then in the supine position. Th e time of spinal injection will be considered time zero (T0). The I.V drug regimen will be started according to the group to which patients will be assigned.patients will receive intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine in group 2 | Drug | group 1 (I.V group ), group 2 (intrathecal group) |
Primary outcome
Postoperative analgesic efficacy
Time frame: 15 minutes intervals for 12 hours postoperatively
duration of sensory blockade of spinal anaesthesia
Postoperative analgesic efficacy
Time frame: 20 minutes intervals for 12 hours postoperatively
duration of motor blockade of spinal anesthesia
4 secondary outcomes
Haemodynamics
Time frame: 1 hours intervals from start of operation until 12 hours postoperatively
Assessment of pain
Time frame: every 1 hour intervals until 12 hours postoperatively
Assessment of sedation
Time frame: every 30 minutes intervals for 12 hours postoperatively
hemodynamics
Time frame: 1 hours intervals from start of operation until 12 hours postoperatively
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 23 Oct 2024.
- Individual participant dataSharing planned: Undecided. analytical data will be available
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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.
ezzat m ali el soudy, professor study chair
professor of anaesthesia and icu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine in people with Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Al-Azhar University 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 3 inclusion and 7 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 23 Oct 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative analgesic efficacy (time frame: 15 minutes intervals for 12 hours postoperatively). The study lists 2 primary outcomes in all. 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 23 Oct 2024.