Anesthesia, SpinalPhase 4NCT02365857
Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section
A Phase 4 study testing Dexmedetomidine & Bupivacaine. and Bupivacaine Only. in people with Anesthesia, Spinal, run by Cairo University.
Trial summary
A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and side effect profile of different dose levels of Dexmedetomidine added to subarachnoid bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Spinal
- What is being tested?
- Dexmedetomidine & Bupivacaine. and Bupivacaine Only.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Oct 2015
- Phase
- Phase 4
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-term pregnant women.
- Elective cesarean section using spinal anesthesia.
- Singleton gestation.
- American Society of Anesthesiologists (ASA) physical status classes I and II.
Who cannot join
- Preterm pregnancy (<37 wks gestation).
- Multiple gestation.
- Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medication.
- Conditions that preclude spinal anesthesia.
- Failed spinal block and conversion to general anesthesia.
- A history of established chronic pain.
Show all 10Show fewer
- Drug addiction.
- A psychiatric disorder.
- Inability to communicate effectively.
- Asthma and allergy to non-steroidal anti-inflammatory drugs.
About this study
Official title: Effects of Intrathecal Dexmedetomidine on the Perioperative Clinical Profile of Bupivacaine-induced Spinal Anesthesia for Cesarean Section
A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and side effect profile of different dose levels of Dexmedetomidine added to subarachnoid bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal anesthesia. The investigators ultimate goal is to find out the least effective dose which will be associated with minimal or no side effects. The primary outcome will be the time to two sensory block segment regression.
Read the detailed description
Alpha 2-agonists are non-opioid adjuvants with a significant role in extending the analgesic duration of subarachnoid block. When clonidine or Dexmedetomidine was added to intrathecal local anesthetics, the regression of sensory and motor blocks increased dose-dependently. Further, a recent meta-analysis including seven randomized controlled studies reported an increase in the duration of analgesia and reduced morphine requirement after the concomitant subarachnoid administration of clonidine.
Animal studies demonstrated that Dexmedetomidine added to bupivacaine significantly enhanced the duration of sensory and motor blockade of sciatic nerve block. Histo-pathological examination proved that all of the nerves analyzed had normal axons and myelin at 24 h and 14 days after the peri-neural administration of Dexmedetomidine. Several clinical studies confirmed the analgesic potentials and safe neurological outcome of neuraxially administered Dexmedetomidine in the non-obstetric settings while intrathecal clonidine proved to be a useful analgesic adjunct for spinal anesthesia in patients undergoing cesarean section. But to the best of the investigator knowledge the effects of intrathecal Dexmedetomidine on the perioperative clinical profile of bupivacaine-induced spinal anesthesia were not studied before in the obstetric patient population.
- Conditions
- Anesthesia, Spinal
- Being tested
- Dexmedetomidine & Bupivacaine., Bupivacaine Only.
- Keywords
- spinal anesthesia, caesarian section, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine & Bupivacaine.Drug
Intrathecal injection of Dexmedetomidine \& Bupivacaine.
Bupivacaine Only.Drug
Intrathecal injection of Bupivacaine only.
| Study group | Role | What they receive |
|---|---|---|
| DEX-5 | Active comparator | Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 5 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds. Receives: Drug: Dexmedetomidine & Bupivacaine. |
| DEX-10 | Active comparator | Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 10 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds. Receives: Drug: Dexmedetomidine & Bupivacaine. |
| DEX-15 | Active comparator | Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 15 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds. Receives: Drug: Dexmedetomidine & Bupivacaine. |
| Control | Active comparator | Bupivacaine Only. Patients will receive intrathecal 12.5 mg isobaric bupivacaine only using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds. Receives: Drug: Bupivacaine Only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to two sensory block segment regression.
Define the start of regression of the level of sensory block
Measured: 70 min
Secondary outcomes (19)
The peak sensory level of the block.
By Pin Prick testing.
Measured: 10 min
Time from intrathecal injection to peak sensory block level.
Define the speed of onset of the block.
Measured: 10 min
Time to S1 level sensory regression.
Define duration of the block.
Measured: 70 min
Degree of motor block.
By Modified Bromage Score.
Measured: 24 h
Intraoperative hemodynamic variables.
Detect frequency of side effects
Measured: 24 h
The total dose of ephedrine/atropine required to maintain hemodynamic stability.
Detect frequency of side effects
Measured: 24 h
The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range
Detect frequency of side effects
Measured: 24 h
Oxygen saturation (the need for O2 supplementation)
Detect frequency of side effects
Measured: 24 h
Intraoperative analgesic supplementation
Define quality of the block
Measured: 70 min
Time to first postoperative rescue analgesic request
Define duration of analgesia by the block
Measured: 24 h
Postoperative pain scores for 24 hours
Define duration of analgesia by the block
Measured: 24 h
Frequency of administration of postoperative analgesics
Define duration of analgesia by the block
Measured: 24 h
Intraoperative sedation scores
Detect frequency of side effects
Measured: 24 h
Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation)
Detect frequency of side effects
Measured: 24 h
New born Apgar Score
Detect any effects on the new born at different dose levels
Measured: 5 min
Duration of motor block.
By Modified Bromage Score.
Measured: 24 h
Early postoperative hemodynamic variables.
Detect frequency of side effects
Measured: 24 h
Total dose of postoperative analgesics
Define duration of analgesia by the block
Measured: 24 h
Postoperative sedation scores
Detect frequency of side effects
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Mohamed Abdulatif Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365857
- Sponsor's protocol ID
- thecaldex
- Status last verified
- Jan 2016
- First submitted
- 4 Feb 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intrathecal Dexmedetomidine on the Perioperative Clinical Profile of Bupivacaine-induced Spinal Anesthesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT02365857
- Acronym / sponsor ID
- thecaldex
- Conditions
- Anesthesia, Spinal
- Keywords
- spinal anesthesia, caesarian section, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- 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.
A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and side effect profile of different dose levels of Dexmedetomidine added to subarachnoid bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal anesthesia. The investigators ultimate goal is to find out the least effective dose which will be associated with minimal or no side effects. The primary outcome will be the time to two sensory block segment regression.
Detailed description
Alpha 2-agonists are non-opioid adjuvants with a significant role in extending the analgesic duration of subarachnoid block. When clonidine or Dexmedetomidine was added to intrathecal local anesthetics, the regression of sensory and motor blocks increased dose-dependently. Further, a recent meta-analysis including seven randomized controlled studies reported an increase in the duration of analgesia and reduced morphine requirement after the concomitant subarachnoid administration of clonidine.
Animal studies demonstrated that Dexmedetomidine added to bupivacaine significantly enhanced the duration of sensory and motor blockade of sciatic nerve block. Histo-pathological examination proved that all of the nerves analyzed had normal axons and myelin at 24 h and 14 days after the peri-neural administration of Dexmedetomidine. Several clinical studies confirmed the analgesic potentials and safe neurological outcome of neuraxially administered Dexmedetomidine in the non-obstetric settings while intrathecal clonidine proved to be a useful analgesic adjunct for spinal anesthesia in patients undergoing cesarean section. But to the best of the investigator knowledge the effects of intrathecal Dexmedetomidine on the perioperative clinical profile of bupivacaine-induced spinal anesthesia were not studied before in the obstetric patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DEX-5 | Active comparator | Drug: Dexmedetomidine & Bupivacaine.Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 5 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds. |
| DEX-10 | Active comparator | Drug: Dexmedetomidine & Bupivacaine.Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 10 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds. |
| DEX-15 | Active comparator | Drug: Dexmedetomidine & Bupivacaine.Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 15 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds. |
| Control | Active comparator | Drug: Bupivacaine Only.Bupivacaine Only. Patients will receive intrathecal 12.5 mg isobaric bupivacaine only using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Full-term pregnant women.
- Elective cesarean section using spinal anesthesia.
- Singleton gestation.
- American Society of Anesthesiologists (ASA) physical status classes I and II.
Key exclusion criteria (10 listed)
- Preterm pregnancy (<37 wks gestation).
- Multiple gestation.
- Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medication.
- Conditions that preclude spinal anesthesia.
- Failed spinal block and conversion to general 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 |
|---|---|---|
| Dexmedetomidine & Bupivacaine.Intrathecal injection of Dexmedetomidine \& Bupivacaine. | Drug | DEX-10, DEX-15, DEX-5 |
| Bupivacaine Only.Intrathecal injection of Bupivacaine only. | Drug | Control |
Primary outcome
The time to two sensory block segment regression.
Time frame: 70 min
Define the start of regression of the level of sensory block
19 secondary outcomes
The peak sensory level of the block.
Time frame: 10 min
Time from intrathecal injection to peak sensory block level.
Time frame: 10 min
Time to S1 level sensory regression.
Time frame: 70 min
Degree of motor block.
Time frame: 24 h
Intraoperative hemodynamic variables.
Time frame: 24 h
The total dose of ephedrine/atropine required to maintain hemodynamic stability.
Time frame: 24 h
The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range
Time frame: 24 h
Oxygen saturation (the need for O2 supplementation)
Time frame: 24 h
Intraoperative analgesic supplementation
Time frame: 70 min
Time to first postoperative rescue analgesic request
Time frame: 24 h
Postoperative pain scores for 24 hours
Time frame: 24 h
Frequency of administration of postoperative analgesics
Time frame: 24 h
Intraoperative sedation scores
Time frame: 24 h
Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation)
Time frame: 24 h
New born Apgar Score
Time frame: 5 min
Duration of motor block.
Time frame: 24 h
Early postoperative hemodynamic variables.
Time frame: 24 h
Total dose of postoperative analgesics
Time frame: 24 h
Postoperative sedation scores
Time frame: 24 h
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 2 Feb 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine & Bupivacaine. and Bupivacaine Only. in people with Anesthesia, Spinal, run by Cairo University.
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 10 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The time to two sensory block segment regression. (time frame: 70 min). 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 2 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.