Post Spinal Anesthesia Shiveringdexmed_ACBNCT04266145
Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty
A study testing intravenous dexmedetomidine and adductor canal block dexmedetomidine in people with Post Spinal Anesthesia Shivering, run by Mansoura University at 1 site in Egypt.
Trial summary
Shivering increases the cardiac and systemic energy expenditure, oxygen consumption and carbon dioxide production. Definitive prevention and treatment of shivering is necessary to decrease the related complications and increase post-anesthetic comfort. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Post Spinal Anesthesia Shivering
- What is being tested?
- intravenous dexmedetomidine and adductor canal block dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Feb 2020to 25 Aug 2022
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- both genders
- American Society of Anesthesiologists physical status I and II
- scheduled for unilateral primary TKA under spinal anesthesia
Who cannot join
- chronic opioid use
- known allergy to the used drugs
- any contraindications to regional anesthesia like; patient refusal, coagulopathy, neuropathy or infection at the injection site
Trial locations and contacts
1 site in 1 country.
About this study
Shivering increases the cardiac and systemic energy expenditure, oxygen consumption and carbon dioxide production. Definitive prevention and treatment of shivering is necessary to decrease the related complications and increase post-anesthetic comfort.
Read the detailed description
Dexmedetomidine a highly selective α2 adrenergic agonist used effectively as a safe analgesic via different routes and mechanisms, including intravenous (i.v.), neuraxial and perineural routes. Dexmedetomidine has been used for prevent shivering but, the results of its efficacy is still controversy.
No studies to date have investigated the best administration route of dexmedetomidine to dominantly prevent the occurrence of shivering after spinal anesthesia or associated with the least grade.
This prospective, randomized, double blinded study was designed to investigate the best administrative route of dexmedetomidine firstly, as a preventive of neuraxial shivering and secondly as adjunctive analgesic.
The incidence of post-spinal anesthesia shivering was the primary outcome. Perioperative hemodynamics, postoperative pain scores during rest and at 45-degree flexion of the knee, the analgesic duration, the first postoperative day analgesic consumption, the sedation score and early ambulation ability were the secondary outcomes.
- Conditions
- Post Spinal Anesthesia Shivering
- Being tested
- intravenous dexmedetomidine, adductor canal block dexmedetomidine
- Keywords
- dexmedetomidine-adductor canal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous dexmedetomidineDrug
adductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL normal saline while, the intravenous solution; consists of 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline
adductor canal block dexmedetomidineDrug
adductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL of 0.5µg.kg-1 dexmedetomidineline while, the intravenous solution;consists of 20 mL normal saline
| Study group | Role | What they receive |
|---|---|---|
| intravenous dexmedetomidine | Active comparator | 20 mL 0.25% levobupivacaine plus 1 mL normal saline will be administrated for adductor-canal-blockade while for intravenous solution; 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline will be prepared Receives: Drug: intravenous dexmedetomidine |
| adductor-canal-blockade dexmedetomidine | Active comparator | 20 mL 0.25% levobupivacaine containing 1 mL of 0.5 mcg.kg-1 dexmedetomidine will be used for adductor-canal-blockade whereas, 20 mL 0.9% saline will be prepared for intravenous infusion Receives: Drug: adductor canal block dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post-spinal anesthesia shivering
5-point scale (0= no shivering, 1 =piloerection or peripheral vasoconstriction but no visible shivering; 2 =muscular activity in only one muscle group; 3 =muscular activity in more than one muscle group but not generalized and 4 = shivering involving the whole body)
Measured: up to 24 hours
Secondary outcomes (6)
The analgesic duration
the time from adductor-canal-blockade injection till the first of postoperative dose of rescue analgesic
Measured: during the first postoperative 24 hours
total cumulative doses of rescue analgesic
given when visual analog scale for pain ≥ 40
Measured: after the first postoperative 24 hours
Modified Ramsay sedation scale
- Awake and alert, minimal or no cognitive impairment
- Awake but tranquil, purposeful responses to verbal commands at a conversational level
- Appears asleep, purposeful response to verbal commands at a conversational level
- Appears asleep, purposeful responses to commands but at a louder than conversational level, requiring light glabellar tap, or both
- Asleep, sluggish purposeful responses only to loud verbal commands, strong glabellar tap, or both
- Asleep, sluggish purposeful responses only to painful stimuli
- Asleep, reflex withdrawal to painful stimuli only
- Unresponsive to external stimuli, including pain
Measured: after 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively
non-invasive arterial blood pressure
mmHg
Measured: every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative
Heart rate
beat per minute
Measured: every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative
postoperative pain
visual analog scale for pain (0 mm= no pain, and 100 = the worst possible pain)
Measured: preoperative, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start29 Feb 2020
- Primary completion1 Jul 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anesthesia ShiveringStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
- Investigators
- Maha Abozeid, MD, Principal investigator, Faculty of Medicine - Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266145
- Sponsor's protocol ID
- dexmedetomidine
- Acronym
- dexmed_ACB
- Status last verified
- Aug 2022
- First submitted
- 10 Feb 2020
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04266145
- Acronym / sponsor ID
- dexmed_ACB / dexmedetomidine
- Conditions
- Post Spinal Anesthesia Shivering
- Keywords
- dexmedetomidine-adductor canal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 29 Feb 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 12 Feb 2020 (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.
Shivering increases the cardiac and systemic energy expenditure, oxygen consumption and carbon dioxide production. Definitive prevention and treatment of shivering is necessary to decrease the related complications and increase post-anesthetic comfort.
Detailed description
Dexmedetomidine a highly selective α2 adrenergic agonist used effectively as a safe analgesic via different routes and mechanisms, including intravenous (i.v.), neuraxial and perineural routes. Dexmedetomidine has been used for prevent shivering but, the results of its efficacy is still controversy.
No studies to date have investigated the best administration route of dexmedetomidine to dominantly prevent the occurrence of shivering after spinal anesthesia or associated with the least grade.
This prospective, randomized, double blinded study was designed to investigate the best administrative route of dexmedetomidine firstly, as a preventive of neuraxial shivering and secondly as adjunctive analgesic.
The incidence of post-spinal anesthesia shivering was the primary outcome. Perioperative hemodynamics, postoperative pain scores during rest and at 45-degree flexion of the knee, the analgesic duration, the first postoperative day analgesic consumption, the sedation score and early ambulation ability were the secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous dexmedetomidine | Active comparator | Drug: intravenous dexmedetomidine20 mL 0.25% levobupivacaine plus 1 mL normal saline will be administrated for adductor-canal-blockade while for intravenous solution; 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline will be prepared |
| adductor-canal-blockade dexmedetomidine | Active comparator | Drug: adductor canal block dexmedetomidine20 mL 0.25% levobupivacaine containing 1 mL of 0.5 mcg.kg-1 dexmedetomidine will be used for adductor-canal-blockade whereas, 20 mL 0.9% saline will be prepared for intravenous infusion |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients
- both genders
- American Society of Anesthesiologists physical status I and II
- scheduled for unilateral primary TKA under spinal anesthesia
Key exclusion criteria (3 listed)
- chronic opioid use
- known allergy to the used drugs
- any contraindications to regional anesthesia like; patient refusal, coagulopathy, neuropathy or infection at the injection site
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 |
|---|---|---|
| intravenous dexmedetomidineadductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL normal saline while, the intravenous solution; consists of 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline | Drug | intravenous dexmedetomidine |
| adductor canal block dexmedetomidineadductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL of 0.5µg.kg-1 dexmedetomidineline while, the intravenous solution;consists of 20 mL normal saline | Drug | adductor-canal-blockade dexmedetomidine |
Primary outcome
incidence of post-spinal anesthesia shivering
Time frame: up to 24 hours
5-point scale (0= no shivering, 1 =piloerection or peripheral vasoconstriction but no visible shivering; 2 =muscular activity in only one muscle group; 3 =muscular activity in more than one muscle group but not generalized and 4 = shivering involving the whole body)
6 secondary outcomes
The analgesic duration
Time frame: during the first postoperative 24 hours
total cumulative doses of rescue analgesic
Time frame: after the first postoperative 24 hours
Modified Ramsay sedation scale
Time frame: after 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively
non-invasive arterial blood pressure
Time frame: every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative
Heart rate
Time frame: every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative
postoperative pain
Time frame: preoperative, 2, 4, 6, 8, 10, 12 and 24 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 29 Aug 2022.
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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.
Maha Abozeid, MD principal investigator
Faculty of Medicine - Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous dexmedetomidine and adductor canal block dexmedetomidine in people with Post Spinal Anesthesia Shivering, 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 4 inclusion and 3 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 29 Aug 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.
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?
incidence of post-spinal anesthesia shivering (time frame: up to 24 hours). 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 29 Aug 2022.