Lower Limb SurgeryNCT02660658
Optimal Single Dose Intrathecal Dexmedetomidine for Postoperative Analgesia
A study testing Intrathecal dexmedetomidine in people with Lower Limb Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
Spinal anesthesia is a commonly used technique for lower limb surgeries offering better quality of postoperative analgesia, lower incidence of side effects, and shorter post-anesthesia care unit stay than general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Limb Surgery
- What is being tested?
- Intrathecal dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Jun 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical class I to II.
- Patients scheduled for elective lower limb surgeries.
Who cannot join
- Morbid obese patients.
- Severe or uncompensated cardiovascular disease.
- Significant renal disease.
- Significant hepatic disease.
- Pregnancy.
- Lactating .
Show all 21Show fewer
- Heart block.
- Bradyarrhythmias.
- Receiving adrenergic receptor antagonist medications.
- Receiving calcium channel blockers.
- Patients with pacemakers.
- Patients with implanted cardioverter defibrillator.
- Allergy to the study medications.
- Psychological disease.
- Neurological disorders.
- Communication barrier.
- Mental disorders.
- Epilepsy.
- Drug or alcohol abuse.
- Contraindications to spinal anaesthesia.
- Receiving opioid analgesic medications within 24 h before the operation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university
Al Mansurah, DK, 050
Samah Elkenany, MD, 00201002262557, sk_20022000@yahoo.com
About this study
Official title: Optimal Single-dose Intrathecal Dexmedetomidine for Postoperative Analgesia After Lower Limb Surgery
Spinal anesthesia is a commonly used technique for lower limb surgeries offering better quality of postoperative analgesia, lower incidence of side effects, and shorter post-anesthesia care unit stay than general anesthesia. However, the relatively short duration of action of the currently available local anesthetics (LAs) make these advantages short-lived.
The risk for local anesthetic toxicity (LAST) increases with the trials to use higher concentrations or volumes of intrathecal local anesthetics to increase the duration of analgesia.
Dexmedetomidine has the potential to prolong the duration of perioperative analgesia without the need for using high doses of local anesthetics and hence with decreasing the potential risk of local anesthetic, but the increased likelihood adverse effects such as short term bradycardia and prolonged duration of motor block may offset these benefits.
Read the detailed description
The aim of this study is to determine the optimal single-dose of intrathecal dexmedetomidine that prolongs the analgesic duration with the least possible side effects.
With the patients in the sitting position and the use of complete aseptic technique, 25G Whitacre spinal needles will be introduced through L2-L4 interspaces and after observing free flow of the CSF, a 3ml volume including bupivacaine 12.5mg in conjunction with dexmedetomidine (3 µg) will be injected in the first case, then the patient will be turned supine.
The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance.
- Conditions
- Lower Limb Surgery
- Being tested
- Intrathecal dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal dexmedetomidineDrug
The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal dexmedetomidine | Other | Up-down sequential allocation
The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance Receives: Drug: Intrathecal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
The duration of analgesia, defined as the time from administering of intrathecal study solution (T0) to the time for the first rescue analgesic request
Measured: For 13 hours after surgery
Secondary outcomes (13)
Postoperative pain score
Using visual analog scale
Measured: For 24 hours after surgery
Onset of sensory blockade
Onset of sensory block time defined as the time elapsed from T0 to achieve the adequate sensory level for the planned surgery.
Measured: For 1 hour after initiaion of spinal anesthesia
Onset of motor blockade
Onset of motor block time defined as the time elapsed from T0 to achieve the Bromage scale of 3
Measured: For 2 hours after initiation of spinal anesthesia
Highest dermatome level of sensory blockade
The highest dermatome level of sensory blockade and the time needed to achieve this level from the time of injection as well as time to two segment sensory regression after T0 will be recorded
Measured: For 4 hours after initiation of spinal anesthesia
Time to motor regression
Time to motor regression to a Bromage scale of 2
Measured: For 6 hours after initiation of spinal anesthesia
Sedation score
Sedation scores will be assessed using a sedation scale (awake and alert= 0; quietly awake= 1; asleep but easily roused= 2; deep sleep= 3).
Measured: For 24 hours after initiation of spinal anesthesia
Postoperative nausea and vomiting
The degree of nausea and vomiting. Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3)
Measured: For 24 hours after initiation of spinal anesthesia
Cumulative tramadol consumption
Measured: For 24 hours after surgery
Intraoperative bradycardia
Measured: For 4 hours after initiation of spinal anesthesia
Intraoperative use of ephedrine
Measured: For 4 hours after initiation of spinal anesthesia
Intraoperative use of atropine
Measured: For 4 hours after initiation of spinal anesthesia
Intraoperative use of supplemental fentanyl
Measured: For 4 hours after initiation of spinal anesthesia
Intraoperative use of midazolam
Measured: For 4 hours after initiation of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samah Elkenany, MD, Principal investigator, Lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660658
- Sponsor's protocol ID
- R ∕ 16.01.15
- Status last verified
- Feb 2017
- First submitted
- 16 Jan 2016
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Single-dose Intrathecal Dexmedetomidine for Postoperative Analgesia After Lower Limb Surgery
- ClinicalTrials.gov ID
- NCT02660658
- Acronym / sponsor ID
- R ∕ 16.01.15
- Conditions
- Lower Limb Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 21 Jan 2016 (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.
Spinal anesthesia is a commonly used technique for lower limb surgeries offering better quality of postoperative analgesia, lower incidence of side effects, and shorter post-anesthesia care unit stay than general anesthesia. However, the relatively short duration of action of the currently available local anesthetics (LAs) make these advantages short-lived.
The risk for local anesthetic toxicity (LAST) increases with the trials to use higher concentrations or volumes of intrathecal local anesthetics to increase the duration of analgesia.
Dexmedetomidine has the potential to prolong the duration of perioperative analgesia without the need for using high doses of local anesthetics and hence with decreasing the potential risk of local anesthetic, but the increased likelihood adverse effects such as short term bradycardia and prolonged duration of motor block may offset these benefits.
Detailed description
The aim of this study is to determine the optimal single-dose of intrathecal dexmedetomidine that prolongs the analgesic duration with the least possible side effects.
With the patients in the sitting position and the use of complete aseptic technique, 25G Whitacre spinal needles will be introduced through L2-L4 interspaces and after observing free flow of the CSF, a 3ml volume including bupivacaine 12.5mg in conjunction with dexmedetomidine (3 µg) will be injected in the first case, then the patient will be turned supine.
The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrathecal dexmedetomidine | Other | Drug: Intrathecal dexmedetomidineUp-down sequential allocation The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical class I to II.
- Patients scheduled for elective lower limb surgeries.
Key exclusion criteria (21 listed)
- Morbid obese patients.
- Severe or uncompensated cardiovascular disease.
- Significant renal disease.
- Significant hepatic disease.
- Pregnancy.
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 |
|---|---|---|
| Intrathecal dexmedetomidineThe dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance | Drug | Intrathecal dexmedetomidine |
Primary outcome
Duration of analgesia
Time frame: For 13 hours after surgery
The duration of analgesia, defined as the time from administering of intrathecal study solution (T0) to the time for the first rescue analgesic request
13 secondary outcomes
Postoperative pain score
Time frame: For 24 hours after surgery
Onset of sensory blockade
Time frame: For 1 hour after initiaion of spinal anesthesia
Onset of motor blockade
Time frame: For 2 hours after initiation of spinal anesthesia
Highest dermatome level of sensory blockade
Time frame: For 4 hours after initiation of spinal anesthesia
Time to motor regression
Time frame: For 6 hours after initiation of spinal anesthesia
Sedation score
Time frame: For 24 hours after initiation of spinal anesthesia
Postoperative nausea and vomiting
Time frame: For 24 hours after initiation of spinal anesthesia
Cumulative tramadol consumption
Time frame: For 24 hours after surgery
Intraoperative bradycardia
Time frame: For 4 hours after initiation of spinal anesthesia
Intraoperative use of ephedrine
Time frame: For 4 hours after initiation of spinal anesthesia
Intraoperative use of atropine
Time frame: For 4 hours after initiation of spinal anesthesia
Intraoperative use of supplemental fentanyl
Time frame: For 4 hours after initiation of spinal anesthesia
Intraoperative use of midazolam
Time frame: For 4 hours after initiation of spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Samah Elkenany, MD principal investigator
Lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal dexmedetomidine in people with Lower Limb Surgery, run by Mansoura 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 2 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 27 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samah Elkenany, MD (00201002262557, sk_20022000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: For 13 hours after surgery). 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 27 Feb 2017.