DexmedetomidinePhase 2/3NCT06662175
Role of Dexmedetomidine as Synergistic Agent
A Phase 2/3 study testing Hyperbaric bupivacaine and hyperbaric bupivacaine and dexmedetomidine in people with Dexmedetomidine and Hyperbaric Bupivacaine, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
Trial summary
The aim of this clinical trial is to contribute valuable insights into the role of Dexmedetomidine as a synergistic agent in prolonging subarachnoid block duration, with the overarching goal of enhancing perioperative care and surgical success rates. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dexmedetomidine, Hyperbaric Bupivacaine, Subarachnoid Anesthesia
- What is being tested?
- Hyperbaric bupivacaine and hyperbaric bupivacaine and dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2024to Sep 2025
- Phase
- Phase 2/3
- 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
- Patients of either gender aged between 18 and 65 years.
- Patients scheduled for surgical procedures of lower limb requiring subarachnoid anesthesia.
- American Society of Anesthesiologists (ASA) physical status classification I or II.
Who cannot join
- Patients with contraindications to subarachnoid anesthesia, including severe coagulopathy, infection at the site of injection, or increased intracranial pressure.
- Patients with a history of significant cardiac, respiratory, hepatic, or renal disease.
- Pregnant or lactating women.
- Patients with a history of substance abuse or dependence.
- Patients on chronic opioid therapy or with opioid tolerance.
- Patients with neurological deficits affecting sensation or motor function in the lower extremities.
- Patients with psychiatric disorders affecting their ability to cooperate during the procedure or follow instructions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lady Reading Hospital Mti Peshawar Kp Pakistan
Peshawar, KPK, 25000
FARYAL UZMA, MBBS, +923315138986, faryaluzma1606@gmail.com
FAIZAN SADIQ, MBBS, +923339714679, faizan2308@gmail.com
About this study
Official title: Role of Dexmedetomidine as Synergistic Agent to Prolong a Subarachnoid Block Duration
The aim of this clinical trial is to contribute valuable insights into the role of Dexmedetomidine as a synergistic agent in prolonging subarachnoid block duration, with the overarching goal of enhancing perioperative care and surgical success rates.
Read the detailed description
Dexmedetomidine is a frequently used alpha-2 adrenergic agonist for anesthesia and sedation due to its excellent selectivity. Dexmedetomidine can cause drowsiness, analgesia, and sympathetic reactions when injected intravenously. Dexmedetomidine has been investigated for possible synergistic benefits when used in conjunction with hyperbaric bupivacaine for subarachnoid block, sometimes referred to as spinal anesthesia. Because hyperbaric bupivacaine can produce a rapid onset and a longer duration of sensory and motor blockage, it is a common local anesthetic used in spinal anesthesia.
Numerous research studies have examined the synergistic effects of intravenous dexmedetomidine and hyperbaric bupivacaine in subarachnoid blocks. These effects are primarily observed in terms of extending the duration of sensory and motor blockade, enhancing postoperative analgesia, decreasing intraoperative and postoperative opioid consumption, and improving patient satisfaction. The mechanism underlying this synergistic effect is believed to be connected to the effects of dexmedetomidine on the central nervous system, which include its capacity to modify pain pathways, improve spinal anesthesia, and produce drowsiness and anxiolysis.
Although the combination of dexmedetomidine with hyperbaric bupivacaine has demonstrated encouraging outcomes in a number of studies, there is still discussion and continuing research over the best time, dosage, and patient selection criteria. As with any anesthesia procedure, the best course of action should be determined after taking into account specific patient considerations such age, comorbidities, and concurrent drugs.
Hameed et al compare the Synergistic effect of Dexmedetomidine on Subarachnoid Block with Hyperbaric Bupivacaine among three groups. In there study Patients in Group 1 received 2 ml of intrathecal bupivacaine; Group 2 received a combination of bupivacaine and Dexmedetomidine infusion; and Group 3 received bupivacaine followed by Dexmedetomidine infusion. Their study show that onset time of sensory blockade. The duration of sensory blockade and the rate of recovery of complete sensory block was significantly higher in Group 2 compared to Group 1. The distribution of adverse effect among group 1 and group 2 was, hypotension 20% vs 40%, Bradycadria 8% vs 24%, and Nausea 12% vs 12% respectively.
Previous studies have indicated that Dexmedetomidine can enhance the duration and quality of sensory blockade, improve postoperative analgesia, and reduce opioid consumption when used in conjunction with hyperbaric bupivacaine. Despite these promising findings, further exploration is warranted to elucidate the optimal dosage, timing, and patient selection criteria for Dexmedetomidine administration in subarachnoid blocks. Understanding the mechanistic basis of Dexmedetomidine's synergistic effects on subarachnoid block duration is crucial for refining anesthesia protocols and ultimately improving patient outcomes. By conducting this research study, the investigators aim to contribute valuable insights into the role of Dexmedetomidine as a synergistic agent in prolonging subarachnoid block duration, with the overarching goal of enhancing perioperative care and surgical success rates.
- Being tested
- Hyperbaric bupivacaine, hyperbaric bupivacaine and dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric bupivacaineDrug
Group A (Unexposed) will received 2 ml of intrathecal bupivacaine
hyperbaric bupivacaine and dexmedetomidineDrug
Group B (Exposed) will receive a combination of bupivacaine and Dexmedetomidine infusion
| Study group | Role | What they receive |
|---|---|---|
| Group A Hyperbaric Bupivicaine | Experimental | Group A (Unexposed) will received 2 ml of intrathecal bupivacaine. Receives: Drug: Hyperbaric bupivacaine |
| GROUP B Hyperbaric Bupivacaine and Dexmedetomidine | Experimental | Group B (Exposed) will receive a combination of bupivacaine and Dexmedetomidine infusion. Receives: Drug: hyperbaric bupivacaine and dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of Dexmedetomidine when used adjunctively with hyperbaric bupivacaine in extending the duration of sensory and motor blockade in subarachnoid anesthesia.
Sensory Blockade Duration: This refers to the time interval from the administration of the subarachnoid block until the complete recovery of sensory function in the dermatomes affected by the anesthesia. It will be assessed using standardized sensory tests, such as pinprick or cold sensation, within the affected dermatomes.
Motor Blockade Duration:It encompasses the time from the onset of motor blockade to the complete recovery of motor function and will assessed by evaluating muscle strength and movement capability using modified Bromage score as
0=Subject is able to lift the leg straight and move the hip, knee and ankle.
- Subject is unable to lift the leg straight but is able to lift the leg straight but is able to flex the knee and ankle freely.
- Subject is unable to flex the knee and hip, but is able to flex the ankle.
- Subject is unable to flex the ankle, knee, and hip, but is able to move toes.
- No movement in the lower extremity.
Measured: periodically motor blockade will be assessed until the achievement of modified Bromage score 3 from giving anesthesia till shifting of the patient to parent ward
Secondary outcomes (1)
Investigate the safety profile of Dexmedetomidine in combination with hyperbaric bupivacaine, in term of adverse events such as hypotension, bradycardia, and patient satisfaction.
Sedation levels will be assessed using the Ramsay score
- Awake; agitated or restless or both
- Awake; cooperative, oriented, and tranquil
- Awake but responds to commands only
- Asleep; brisk response to light glabellar tap or loud auditory stimulus
- Asleep; sluggish response to light glabellar tap or loud auditory stimulus
- Asleep; no response to glabellar tap or loud auditory stimulus Adverse Event: will be measured in following term Hypotension: defined as a systolic blood pressure less than 90 mm Hg or a mean arterial pressure below 60 mm Hg.
Bradycardia:defined as a heart rate of less than 50 beats per minute. Patient Satisfaction:defined in terms of subjective assessment of the patient's physical and emotional well-being during the procedure include observed signs of distress, facial expressions, and verbal feedback. Patients' satisfaction will be assessed using a 10cm Visual Analogue Score. Where 10cm denoted maximal satisfaction and 0cm denoted minimal.
Measured: till the shifting of patient to parent ward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DexmedetomidineStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Reading Hospital, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Faryal Uzma, Lady Reading Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662175
- Sponsor's protocol ID
- 359/LRH/MTI
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the patients identity will be kept anonymous
Publications
Sharma A, Varghese N, Venkateswaran R. Effect of intrathecal dexmedetomidine versus intravenous dexmedetomidine on subarachnoid anesthesia with hyperbaric bupivacaine. J Anaesthesiol Clin Pharmacol. 2020 Jul-Sep;36(3):381-385. doi: 10.4103/joacp.JOACP_323_17. Epub 2020 Sep 14.
PubMed 33487907
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dexmedetomidine as Synergistic Agent to Prolong a Subarachnoid Block Duration
- ClinicalTrials.gov ID
- NCT06662175
- Acronym / sponsor ID
- 359/LRH/MTI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Lady Reading Hospital, PakistanOther government
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 28 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.
The aim of this clinical trial is to contribute valuable insights into the role of Dexmedetomidine as a synergistic agent in prolonging subarachnoid block duration, with the overarching goal of enhancing perioperative care and surgical success rates.
Detailed description
Dexmedetomidine is a frequently used alpha-2 adrenergic agonist for anesthesia and sedation due to its excellent selectivity. Dexmedetomidine can cause drowsiness, analgesia, and sympathetic reactions when injected intravenously. Dexmedetomidine has been investigated for possible synergistic benefits when used in conjunction with hyperbaric bupivacaine for subarachnoid block, sometimes referred to as spinal anesthesia. Because hyperbaric bupivacaine can produce a rapid onset and a longer duration of sensory and motor blockage, it is a common local anesthetic used in spinal anesthesia.
Numerous research studies have examined the synergistic effects of intravenous dexmedetomidine and hyperbaric bupivacaine in subarachnoid blocks. These effects are primarily observed in terms of extending the duration of sensory and motor blockade, enhancing postoperative analgesia, decreasing intraoperative and postoperative opioid consumption, and improving patient satisfaction. The mechanism underlying this synergistic effect is believed to be connected to the effects of dexmedetomidine on the central nervous system, which include its capacity to modify pain pathways, improve spinal anesthesia, and produce drowsiness and anxiolysis.
Although the combination of dexmedetomidine with hyperbaric bupivacaine has demonstrated encouraging outcomes in a number of studies, there is still discussion and continuing research over the best time, dosage, and patient selection criteria. As with any anesthesia procedure, the best course of action should be determined after taking into account specific patient considerations such age, comorbidities, and concurrent drugs.
Hameed et al compare the Synergistic effect of Dexmedetomidine on Subarachnoid Block with Hyperbaric Bupivacaine among three groups. In there study Patients in Group 1 received 2 ml of intrathecal bupivacaine; Group 2 received a combination of bupivacaine and Dexmedetomidine infusion; and Group 3 received bupivacaine followed by Dexmedetomidine infusion. Their study show that onset time of sensory blockade. The duration of sensory blockade and the rate of recovery of complete sensory block was significantly higher in Group 2 compared to Group 1. The distribution of adverse effect among group 1 and group 2 was, hypotension 20% vs 40%, Bradycadria 8% vs 24%, and Nausea 12% vs 12% respectively.
Previous studies have indicated that Dexmedetomidine can enhance the duration and quality of sensory blockade, improve postoperative analgesia, and reduce opioid consumption when used in conjunction with hyperbaric bupivacaine. Despite these promising findings, further exploration is warranted to elucidate the optimal dosage, timing, and patient selection criteria for Dexmedetomidine administration in subarachnoid blocks. Understanding the mechanistic basis of Dexmedetomidine's synergistic effects on subarachnoid block duration is crucial for refining anesthesia protocols and ultimately improving patient outcomes. By conducting this research study, the investigators aim to contribute valuable insights into the role of Dexmedetomidine as a synergistic agent in prolonging subarachnoid block duration, with the overarching goal of enhancing perioperative care and surgical success rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Hyperbaric Bupivicaine | Experimental | Drug: Hyperbaric bupivacaineGroup A (Unexposed) will received 2 ml of intrathecal bupivacaine. |
| GROUP B Hyperbaric Bupivacaine and Dexmedetomidine | Experimental | Drug: hyperbaric bupivacaine and dexmedetomidineGroup B (Exposed) will receive a combination of bupivacaine and Dexmedetomidine infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either gender aged between 18 and 65 years.
- Patients scheduled for surgical procedures of lower limb requiring subarachnoid anesthesia.
- American Society of Anesthesiologists (ASA) physical status classification I or II.
Key exclusion criteria (7 listed)
- Patients with contraindications to subarachnoid anesthesia, including severe coagulopathy, infection at the site of injection, or increased intracranial pressure.
- Patients with a history of significant cardiac, respiratory, hepatic, or renal disease.
- Pregnant or lactating women.
- Patients with a history of substance abuse or dependence.
- Patients on chronic opioid therapy or with opioid tolerance.
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 bupivacaineGroup A (Unexposed) will received 2 ml of intrathecal bupivacaine | Drug | Group A Hyperbaric Bupivicaine |
| hyperbaric bupivacaine and dexmedetomidineGroup B (Exposed) will receive a combination of bupivacaine and Dexmedetomidine infusion | Drug | GROUP B Hyperbaric Bupivacaine and Dexmedetomidine |
Primary outcome
Evaluate the efficacy of Dexmedetomidine when used adjunctively with hyperbaric bupivacaine in extending the duration of sensory and motor blockade in subarachnoid anesthesia.
Time frame: periodically motor blockade will be assessed until the achievement of modified Bromage score 3 from giving anesthesia till shifting of the patient to parent ward
Sensory Blockade Duration: This refers to the time interval from the administration of the subarachnoid block until the complete recovery of sensory function in the dermatomes affected by the anesthesia. It will be assessed using standardized sensory tests, such as pinprick or cold sensation, within the affected dermatomes. Motor Blockade Duration:It encompasses the time from the onset of motor blockade to the complete recovery of motor function and will assessed by evaluating muscle strength and movement capability using modified Bromage score as 0=Subject is able to lift the leg straight and move the hip, knee and ankle. 1. Subject is unable to lift the leg straight but is able to lift the leg straight but is able to flex the knee and ankle freely. 2. Subject is unable to flex the knee and hip, but is able to flex the ankle. 3. Subject is unable to flex the ankle, knee, and hip, but is able to move toes. 4. No movement in the lower extremity.
1 secondary outcome
Investigate the safety profile of Dexmedetomidine in combination with hyperbaric bupivacaine, in term of adverse events such as hypotension, bradycardia, and patient satisfaction.
Time frame: till the shifting of patient to parent ward.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Background: PubMed 33487907Sharma A, Varghese N, Venkateswaran R. Effect of intrathecal dexmedetomidine versus intravenous dexmedetomidine on subarachnoid anesthesia with hyperbaric bupivacaine. J Anaesthesiol Clin Pharmacol. 2020 Jul-Sep;36(3):381-385. doi: 10.4103/joacp.JOACP_323_17. Epub 2020 Sep 14.
- Individual participant dataSharing planned: No. the patients identity will be kept anonymous
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyperbaric bupivacaine and hyperbaric bupivacaine and dexmedetomidine in people with Dexmedetomidine and Hyperbaric Bupivacaine, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
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 3 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: status not confirmed, as of the sponsor's last update on 28 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 Pakistan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 FARYAL UZMA, MBBS (+923315138986, faryaluzma1606@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of Dexmedetomidine when used adjunctively with hyperbaric bupivacaine in extending the duration of sensory and motor blockade in subarachnoid anesthesia. (time frame: periodically motor blockade will be assessed until the achievement of modified Bromage score 3 from giving anesthesia till shifting of the patient to parent ward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662175, which also lists 1 linked publication.
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 28 Oct 2024.