Regional Anesthesia MorbidityPhase 4NCT05123170
Dexmedetomidine in IVRA
A Phase 4 study testing Dexmedetomidine Injectable Solution [Dexdomitor] and Lidocaine IV in people with Regional Anesthesia Morbidity, run by Menoufia University at 1 site in Egypt.
Trial summary
A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups, Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- Dexmedetomidine Injectable Solution [Dexdomitor] and Lidocaine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2020to 20 Jun 2021
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of ASA class I and II.
- Patients of either sex.
- Patients aged between 20-70 years.
- Patients scheduled for forearm and hand surgery lasting for about 60 minutes.
Who cannot join
- Patient with known hypersensitivity to any study medications.
- Patient with Severe peripheral vascular disease and neurological disease.
- Where use of tourniquet will be either not possible or contraindicated.
- Patient with Hemolytic diathesis specially sickle cell anemia, epilepsy, diabetes mellitus, hypertension, cardiovascular disease like myocardial infarction, cardiac arrhythmias, heart block and altered mentation.
- Procedures lasting for more than 90 min will be also not considered.
- Therapy with adrenergic receptor antagonist, calcium channel blocker and ACE inhibitors.
- Patient with impaired liver function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Doses of Dexmedetomidine Added to Lignocaine in Patients Posted for Upper Limb Orthopedic Surgery Under Intravenous Regional Anaesthesia
A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups,
Read the detailed description
After obtaining approval of the medical and ethical committee of Menoufia University \& Nasser Institute for Research and Treatment, an informed and written consent from the patients, a prospective controlled randomized double blinded study will be performed
Sample size:
MedCalc® version 12.3.0.0 program "Ostend, Belgium" was used for calculations of sample size, statistical calculator based on 95% confidence interval and power of the study 80% with α error 5%, According to a previous study (13), showed that the duration of tourniquet time in group A was mean 51.60±5.157 and Group B was mean 53.80±4.773, with p-value >0.05, while Quality of block of excellent in group A 83.3% and group B 90%, it turns out that there is success in the group B compared to group A, but there is no difference. So it can be relied upon in this study, based on this assumption, sample size was calculated according to these values produced a minimal samples size of 86 cases were enough to find such a difference. Assuming a drop-out ratio of 5%, the sample size will be 90 cases, subdivided into three groups 30 cases in each group. Patients will be randomly categorized into three equal groups (30 patients each): The patients will be randomly allocated to one of these three groups, using a computer-generated sequence of random numbers and a sealed envelope technique.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- Dexmedetomidine Injectable Solution [Dexdomitor], Lidocaine IV
- Keywords
- Dexmedetomidine, Lignocaine, Upper Limb Orthopedic Surgery, Intravenous Regional Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injectable Solution [Dexdomitor]Drug
two different doses of dexemedetomidine (0.25 μg /kg and 0.5 μg/kg) as adjunct to lignocaine in intravenous regional anesthesia for upper limb orthopedic surgeries
Lidocaine IVDrug
Intravenous regional anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) alone diluted with normal saline 0.9% to make the final volume 30 ml Receives: Drug: Lidocaine IV |
| Group II | Active comparator | Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.25 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml. Receives: Drug: Dexmedetomidine Injectable Solution [Dexdomitor]; Drug: Lidocaine IV |
| Group III | Active comparator | Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.5 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml Receives: Drug: Dexmedetomidine Injectable Solution [Dexdomitor]; Drug: Lidocaine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
hollmen scale
change from base line for the scale (scale from 1 to 4)
Measured: 2 hours
modified bromage scale
change from baseline for the scale (scale from 0 to 4 )
Measured: 2 hours
Secondary outcomes (2)
visual analogue score
changes in the scale from 0 to 10
Measured: 2 hours
ramsey sedation score
changes in the scale from 1 to 4
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start28 Feb 2020
- Primary completion25 Mar 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
- Investigators
- Sadek AM Sadek, MD, Study chair, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123170
- Sponsor's protocol ID
- 2/2020ANET11
- Status last verified
- Jan 2022
- First submitted
- 25 Oct 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Doses of Dexmedetomidine Added to Lignocaine in Patients Posted for Upper Limb Orthopedic Surgery Under Intravenous Regional Anaesthesia
- ClinicalTrials.gov ID
- NCT05123170
- Acronym / sponsor ID
- 2/2020ANET11
- Conditions
- Regional Anesthesia Morbidity
- Keywords
- Dexmedetomidine, Lignocaine, Upper Limb Orthopedic Surgery, Intravenous Regional Anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 17 Nov 2021 (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.
A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups,
Detailed description
After obtaining approval of the medical and ethical committee of Menoufia University \& Nasser Institute for Research and Treatment, an informed and written consent from the patients, a prospective controlled randomized double blinded study will be performed
Sample size:
MedCalc® version 12.3.0.0 program "Ostend, Belgium" was used for calculations of sample size, statistical calculator based on 95% confidence interval and power of the study 80% with α error 5%, According to a previous study (13), showed that the duration of tourniquet time in group A was mean 51.60±5.157 and Group B was mean 53.80±4.773, with p-value >0.05, while Quality of block of excellent in group A 83.3% and group B 90%, it turns out that there is success in the group B compared to group A, but there is no difference. So it can be relied upon in this study, based on this assumption, sample size was calculated according to these values produced a minimal samples size of 86 cases were enough to find such a difference. Assuming a drop-out ratio of 5%, the sample size will be 90 cases, subdivided into three groups 30 cases in each group. Patients will be randomly categorized into three equal groups (30 patients each): The patients will be randomly allocated to one of these three groups, using a computer-generated sequence of random numbers and a sealed envelope technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Lidocaine IVPatients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) alone diluted with normal saline 0.9% to make the final volume 30 ml |
| Group II | Active comparator | Drug: Dexmedetomidine Injectable Solution [Dexdomitor], Drug: Lidocaine IVPatients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.25 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml. |
| Group III | Active comparator | Drug: Dexmedetomidine Injectable Solution [Dexdomitor], Drug: Lidocaine IVPatients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.5 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of ASA class I and II.
- Patients of either sex.
- Patients aged between 20-70 years.
- Patients scheduled for forearm and hand surgery lasting for about 60 minutes.
Key exclusion criteria (7 listed)
- Patient with known hypersensitivity to any study medications.
- Patient with Severe peripheral vascular disease and neurological disease.
- Where use of tourniquet will be either not possible or contraindicated.
- Patient with Hemolytic diathesis specially sickle cell anemia, epilepsy, diabetes mellitus, hypertension, cardiovascular disease like myocardial infarction, cardiac arrhythmias, heart block and altered mentation.
- Procedures lasting for more than 90 min will be also not considered.
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 Injectable Solution [Dexdomitor]two different doses of dexemedetomidine (0.25 μg /kg and 0.5 μg/kg) as adjunct to lignocaine in intravenous regional anesthesia for upper limb orthopedic surgeries | Drug | Group II, Group III |
| Lidocaine IVIntravenous regional anaesthesia | Drug | Group I, Group II, Group III |
Primary outcome
hollmen scale
Time frame: 2 hours
change from base line for the scale (scale from 1 to 4)
modified bromage scale
Time frame: 2 hours
change from baseline for the scale (scale from 0 to 4 )
2 secondary outcomes
visual analogue score
Time frame: 2 hours
ramsey sedation score
Time frame: 2 hours
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 18 Jan 2022.
- 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.
Sadek AM Sadek, MD study chair
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine Injectable Solution [Dexdomitor] and Lidocaine IV in people with Regional Anesthesia Morbidity, run by Menoufia 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 4 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 18 Jan 2022. 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 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?
hollmen scale (time frame: 2 hours). 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 18 Jan 2022.