DexmedetomidineNCT06667024
Dexmedetomidine as an Intrathecal Adjuvant to Hyperbaric Bupivacaine for Postoperative Analgesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries
A study testing Hyperbaric bupivacaine and Dexmedetomidine and Hyperbaric bupivacaine in people with Dexmedetomidine and Intrathecal, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of adding low doses of dexmedetomidine to hyperbaric bupivacaine during spinal anesthesia on post operative analgesia characteristics in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Dexmedetomidine, Intrathecal, Adjuvant
- What is being tested?
- Hyperbaric bupivacaine and Dexmedetomidine and Hyperbaric bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 30 Apr 2024
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged from 21 to 50 years.
- Both genders.
- American society of anesthesiologists (ASA) physical status I and II.
- Patients scheduled for arthroscopic anterior cruciate ligament reconstruction surgeries under spinal anesthesia.
Who cannot join
- Patient refusal.
- Body Mass Index (BMI) more than 40 kg/m2.
- Patients who were taking analgesics for chronic pain on opioid therapy or have a history of drug abuse.
- Uncooperative patient.
- Patients with coagulation disorders.
- History of local anesthetics allergy.
- Infection at the needle puncture site.
- Patients with significant respiratory, cardiac, renal or hepatic disorders
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the effect of adding low doses of dexmedetomidine to hyperbaric bupivacaine during spinal anesthesia on post operative analgesia characteristics in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries
Read the detailed description
The anterior cruciate ligament (ACL) is injured frequently during sports participation. Arthroscopic evaluation of patients with acute traumatic hemarthrosis of the knee has repeatedly demonstrated a 60% to 70% incidence of ACL injury.
Postoperative pain should be effectively treated because it represents an important component of postoperative recovery. Effective treatment serves to blunt autonomic, somatic, and endocrine reflexes with a resultant potential decrease in perioperative morbidity.
Dexmedetomidine is a highly selective α2-adrenergic agonist that has been used for premedication and as an adjunct to general anesthesia. It reduces opioid and inhalational anesthetics requirements.
- Conditions
- Dexmedetomidine, Intrathecal, Adjuvant, Hyperbaric Bupivacaine, Analgesia, Arthroscopic Anterior Cruciate Ligament Reconstruction
- Being tested
- Hyperbaric bupivacaine, Dexmedetomidine and Hyperbaric bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric bupivacaineDrug
Patients received the standard spinal anesthesia with 0.5% 3 ml according to the patient hyperbaric bupivacaine only
Dexmedetomidine and Hyperbaric bupivacaineDrug
Patients received dexmedetomidine 4 μg and 0.5% (3-4 ml according to the patient height) hyperbaric bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients received the standard spinal anesthesia with 0.5% 3 ml according to the patient hyperbaric bupivacaine only. Receives: Drug: Hyperbaric bupivacaine |
| Dexmedetomidine (study) group | Experimental | Patients received dexmedetomidine 4 μg and 0.5% (3-4 ml according to the patient's height) hyperbaric bupivacaine. Receives: Drug: Dexmedetomidine and Hyperbaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
The rescue analgesia was morphine IV bolus of 3 mg with when VAS > 30. Total morphine consumption in the first 24 hours postoperatively was documented.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Time to first rescue analgesia request
Time to the first rescue analgesia (time from end of surgery to first dose of morphine administrated) was recorded
Measured: 24 hours postoperatively
Degree of pain
Degree of pain was assessed using Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 100 represents "the worst pain imaginable"). VAS was assessed at PACU, 1, 2, 4, 8, 12, 18, 24 hours postoperatively.
Measured: 24 hours postoperatively
Duration of motor block
Duration of motor block starting from the time when the Bromage score 3 after spinal anesthesia until the time when the Bromage score was 0 postoperative.
Measured: Intraoperatively
Patient satisfaction
Patients' satisfaction was measured 24 hours postoperative using a five-point Likert scale consisting of:
1: Very dissatisfied, 2: Dissatisfied, 3: Unsure, 4: Satisfied, 5: Very satisfied
Measured: 24 hours postoperatively
Incidence of side effects
Incidence of side effects such as Hypotension, Bradycardia, Shivering, nausea, and vomiting) were recorded.
Measured: 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 posted31 Oct 2024
- Study start1 Sep 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Elsayed Elkasrawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667024
- Sponsor's protocol ID
- 36264MS288/8/23
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Intrathecal Adjuvant to Hyperbaric Bupivacaine for Postoperative Analgesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries
- ClinicalTrials.gov ID
- NCT06667024
- Acronym / sponsor ID
- 36264MS288/8/23
- Conditions
- Dexmedetomidine, Intrathecal, Adjuvant, Hyperbaric Bupivacaine, Analgesia, Arthroscopic Anterior Cruciate Ligament Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 31 Oct 2024 (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.
This study aimed to evaluate the effect of adding low doses of dexmedetomidine to hyperbaric bupivacaine during spinal anesthesia on post operative analgesia characteristics in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries
Detailed description
The anterior cruciate ligament (ACL) is injured frequently during sports participation. Arthroscopic evaluation of patients with acute traumatic hemarthrosis of the knee has repeatedly demonstrated a 60% to 70% incidence of ACL injury.
Postoperative pain should be effectively treated because it represents an important component of postoperative recovery. Effective treatment serves to blunt autonomic, somatic, and endocrine reflexes with a resultant potential decrease in perioperative morbidity.
Dexmedetomidine is a highly selective α2-adrenergic agonist that has been used for premedication and as an adjunct to general anesthesia. It reduces opioid and inhalational anesthetics requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Hyperbaric bupivacainePatients received the standard spinal anesthesia with 0.5% 3 ml according to the patient hyperbaric bupivacaine only. |
| Dexmedetomidine (study) group | Experimental | Drug: Dexmedetomidine and Hyperbaric bupivacainePatients received dexmedetomidine 4 μg and 0.5% (3-4 ml according to the patient's height) hyperbaric bupivacaine. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged from 21 to 50 years.
- Both genders.
- American society of anesthesiologists (ASA) physical status I and II.
- Patients scheduled for arthroscopic anterior cruciate ligament reconstruction surgeries under spinal anesthesia.
Key exclusion criteria (8 listed)
- Patient refusal.
- Body Mass Index (BMI) more than 40 kg/m2.
- Patients who were taking analgesics for chronic pain on opioid therapy or have a history of drug abuse.
- Uncooperative patient.
- Patients with coagulation disorders.
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 |
|---|---|---|
| Hyperbaric bupivacainePatients received the standard spinal anesthesia with 0.5% 3 ml according to the patient hyperbaric bupivacaine only | Drug | Control group |
| Dexmedetomidine and Hyperbaric bupivacainePatients received dexmedetomidine 4 μg and 0.5% (3-4 ml according to the patient height) hyperbaric bupivacaine | Drug | Dexmedetomidine (study) group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
The rescue analgesia was morphine IV bolus of 3 mg with when VAS > 30. Total morphine consumption in the first 24 hours postoperatively was documented.
5 secondary outcomes
Time to first rescue analgesia request
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Duration of motor block
Time frame: Intraoperatively
Patient satisfaction
Time frame: 24 hours postoperatively
Incidence of side effects
Time frame: 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 31 Oct 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric bupivacaine and Dexmedetomidine and Hyperbaric bupivacaine in people with Dexmedetomidine and Intrathecal, run by Tanta 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 8 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 31 Oct 2024. 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?
Total morphine consumption (time frame: 24 hours postoperatively). 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 31 Oct 2024.