Dexmedetomidine in Subarachnoidal AnesthesiaPhase 4DexNCT02582372
Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery
A Phase 4 study testing Dexmedetomidine and bupivacaine and Fentanyl and bupivacaine in people with Dexmedetomidine in Subarachnoidal Anesthesia, run by Hospital Central Dr. Luis Ortega.
Trial summary
Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and motor block with prolonged postoperative analgesia without hemodynamic compromise. OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine spinal anesthesia for lower abdominal surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dexmedetomidine in Subarachnoidal Anesthesia
- What is being tested?
- Dexmedetomidine and bupivacaine and Fentanyl and bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and II
- lower abdominal surgery
Who cannot join
- Consumption antagonists adrenergic or channel blockers Ca ++
- Patients with arrhythmias or heart block
- Allergic to any drugs under study
- Obese
- Physical or mental incapacity to understand and use the pain scale
- Contraindication for anesthesia conductive
- Realization difficulty or complication during anesthesia and / or surgery
About this study
Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and motor block with prolonged postoperative analgesia without hemodynamic compromise.
OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine spinal anesthesia for lower abdominal surgeries.
METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10 mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2 saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block, motor, sedation and peripheral neurological manifestations of toxicity.
- Being tested
- Dexmedetomidine and bupivacaine, Fentanyl and bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine and bupivacaineDrug
10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal
Fentanyl and bupivacaineDrug
25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | 25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge Receives: Drug: Dexmedetomidine and bupivacaine |
| fentanyl | Active comparator | 25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge Receives: Drug: Fentanyl and bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of baseline blood pressure
Measured: during anesthesia and 1 hour of postoperatory
Changes of baseline cardiac rate
Measured: during anesthesia and 1 hour of postoperatory
Changes of baseline oxygen saturation
Measured: during anesthesia and 1 hour of postoperatory
Postoperatory pain visual analogue scale
Measured: during first 24 hours of postoperatory
Changes of motor block using Bromage scale
Measured: during anesthesia and 1 hour of postoperatory
Secondary outcomes (3)
Numbers of patients with hypotension using non invasive blood presure monitor
we report hypotension below 20% of basal values
Measured: during anesthesia and first 24 hours of postoperatory
Numbers of patients with excessive sedation using Ramsay scale
Measured: during anesthesia and first 24 hours of postoperatory
Numbers of patients with nauseas
Measured: during anesthesia and first 24 hours of postoperatory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexmedetomidine in Subarachnoidal AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central Dr. Luis Ortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582372
- Sponsor's protocol ID
- HCLuisOrtega
- Acronym
- Dex
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery
- ClinicalTrials.gov ID
- NCT02582372
- Acronym / sponsor ID
- Dex / HCLuisOrtega
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Central Dr. Luis OrtegaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Oct 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.
Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and motor block with prolonged postoperative analgesia without hemodynamic compromise.
OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine spinal anesthesia for lower abdominal surgeries.
METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10 mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2 saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block, motor, sedation and peripheral neurological manifestations of toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidine and bupivacaine25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge |
| fentanyl | Active comparator | Drug: Fentanyl and bupivacaine25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I and II
- lower abdominal surgery
Key exclusion criteria (7 listed)
- Consumption antagonists adrenergic or channel blockers Ca ++
- Patients with arrhythmias or heart block
- Allergic to any drugs under study
- Obese
- Physical or mental incapacity to understand and use the pain scale
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 and bupivacaine10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal | Drug | dexmedetomidine |
| Fentanyl and bupivacaine25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal | Drug | fentanyl |
Primary outcome
Changes of baseline blood pressure
Time frame: during anesthesia and 1 hour of postoperatory
Changes of baseline cardiac rate
Time frame: during anesthesia and 1 hour of postoperatory
Changes of baseline oxygen saturation
Time frame: during anesthesia and 1 hour of postoperatory
Postoperatory pain visual analogue scale
Time frame: during first 24 hours of postoperatory
Changes of motor block using Bromage scale
Time frame: during anesthesia and 1 hour of postoperatory
3 secondary outcomes
Numbers of patients with hypotension using non invasive blood presure monitor
Time frame: during anesthesia and first 24 hours of postoperatory
Numbers of patients with excessive sedation using Ramsay scale
Time frame: during anesthesia and first 24 hours of postoperatory
Numbers of patients with nauseas
Time frame: during anesthesia and first 24 hours of postoperatory
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 22 Oct 2015.
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 and bupivacaine and Fentanyl and bupivacaine in people with Dexmedetomidine in Subarachnoidal Anesthesia, run by Hospital Central Dr. Luis Ortega.
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 2 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 22 Oct 2015. 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?
Changes of baseline blood pressure (time frame: during anesthesia and 1 hour of postoperatory). The study lists 5 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 22 Oct 2015.