Shoulder LesionsEarly Phase 1NCT05577117
Fentanyl vs Dexmedetomidine for Arthriscopic Shoulder Intervention in Elderly.
A Early Phase 1 study testing Dexmedetomidine in people with Shoulder Lesions, run by Cairo University at 1 site in Egypt.
Trial summary
Arthroscopic shoulder surgeries are commonly used as a minimally invasive surgery for shoulder diseases. however, it causes moderate-to-severe pain and needs stabilization of hemodynamics, without compromising the patient, to the degree that lessens the intraarticular bleeding to provide adequate visualization by the… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Lesions
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2022to 10 Nov 2022
- Phase
- Early Phase 1
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ASA I or II
- aged > 65 years
- undergoing arthroscopic shoulder surgery under general anesthesia.
Who cannot join
- uncontrolled systemic diseases
- significant organ dysfunctions
- morbid obesity (BMI >35)
- history of allergy to the study drugs
- use of beta blockers
- chronic use of opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free Anesthesia Versus Opioid Based Anesthesia for Improvement of the Surgical Field Condition in Elderly Patients Undergoing Arthroscopic Shoulder Surgery. A Randomized Comparative Study
Arthroscopic shoulder surgeries are commonly used as a minimally invasive surgery for shoulder diseases. however, it causes moderate-to-severe pain and needs stabilization of hemodynamics, without compromising the patient, to the degree that lessens the intraarticular bleeding to provide adequate visualization by the surgeon owing to inability to use a tourniquet in this situation.
Opioids have known side effects, like respiratory depression, postoperative nausea and vomiting, pruritus, difficulty in voiding, and ileus. These complications may lead to a prolonged hospital stay.
Read more
The elderly patients are predisposed to a greater hemodynamic changes due to the higher resting sympathetic tone ,altered beta receptor sensitivity , depleted intravascular volume because of frequent use of diuretics, increased myocardial stiffness ,increased arterial stiffness, reduced sinus node function and baroreceptor responsiveness and other patients comorbidities. So they are at increased risk complications as myocardial infarction, stroke and delirium.
Opioid free anesthesia is a technique with no opioids administered intraoperatively through either systemic, neuraxial, or tissue infiltration routes. The number of case reports and small prospective studies from all over the world supports its benefits.
OFA depends on combinations of non-opioid agents and adjuncts, including lidocaine, magnesium, dexmedetomidine, ketamine,and dexamethasone to produce anesthesia, and analgesia.
Dexmedetomidine is an a2 agonist that possesses anxiolytic, anesthetic, hypnotic, and analgesic properties. In addition, it reduces the pressor responses mediated by the sympathetic nervous system.
Lignocaine is a short-acting amide local anaesthetic agent. It is potent as a sodium channel blocker and has been shown to provide excellent analgesia when administered intravenously . The evidence base supports lignocaine as an analgesic agent, an opioid-sparing agent, an anti-inflammatory and a co-anaesthetic.
n,Complex regional pain syndrome,opioid-tolerant patient and early recovery after surgery, however, few studies focused on its ablility to improve the surgical field condition which depends on the hemodynamics especially in elderly patients.
Aim is to Compare OFA with Opioid anesthesia (OA) as regards improvement of the surgical field condition in elderly patients undergoing arthroscopic shoulder surgery under general anesthesia.
Read the detailed description
Arthroscopic shoulder surgeries are commonly used as a minimally invasive surgery for shoulder diseases. however, it causes moderate-to-severe pain and needs stabilization of hemodynamics, without compromising the patient, to the degree that lessens the intraarticular bleeding to provide adequate visualization by the surgeon owing to inability to use a tourniquet in this situation.
Controlling the pain in shoulder surgery facilitates early mobilization, fast functional recovery and allows pain-free muscle contraction.
Opioids have known side effects, like respiratory depression, postoperative nausea and vomiting, pruritus, difficulty in voiding, and ileus. These complications may lead to a prolonged hospital stay.
The elderly patients are predisposed to a greater hemodynamic changes due to the higher resting sympathetic tone ,altered beta receptor sensitivity , depleted intravascular volume because of frequent use of diuretics, increased myocardial stiffness ,increased arterial stiffness, reduced sinus node function and baroreceptor responsiveness and other patients comorbidities. So they are at increased risk complications as myocardial infarction, stroke and delirium.
Opioid free anesthesia is a technique with no opioids administered intraoperatively through either systemic, neuraxial, or tissue infiltration routes. The number of case reports and small prospective studies from all over the world supports its benefits.
Initially, OFA depends on combinations of non-opioid agents and adjuncts, including lidocaine, magnesium, dexmedetomidine, ketamine,and dexamethasone to produce anesthesia, and analgesia.
Magnesium is a non-competitive antagonist of N-methyl-D-aspartate (NMDA) and has anti-inflammatory effects because it decreases interleukin 6 (IL-6) and tumour necrosis factor (TNF-alpha) levels postoperatively.
Dexamethasone is a mineraloglucocorticoid that has been shown to be effective as an antiemetic in a number of surgical operations. Dexamethasone was integrated into the multimodal opioid-free approach based on De Oliveira's and others' findings that dosages of> 0.1 mg/kg exhibit clinically significant analgesic characteristics in lean adults.
Ketamine is another non-competitive antagonist of the n-methyl-D-aspartate receptor and is commonly used either as a small bolus of 0.25-0.5 mg/kg IBW or in a low-dose continuous infusion at 2-2.5 μg/kg/min. Schug and others have summarised its benefits in APMSE4 in both the general acute pain population and bariatric patients.
Dexmedetomidine is an a2 agonist that possesses anxiolytic, anesthetic, hypnotic, and analgesic properties. In addition, it reduces the pressor responses mediated by the sympathetic nervous system.
Lignocaine is a short-acting amide local anaesthetic agent. It is potent as a sodium channel blocker and has been shown to provide excellent analgesia when administered intravenously . The evidence base supports lignocaine as an analgesic agent, an opioid-sparing agent, an anti-inflammatory and a co-anaesthetic.
n ,Complex regional pain syndrome ,opioid-tolerant patient and early recovery after surgery , however, few studies focused on its ability to improve the surgical field condition which depends on the hemodynamics especially in elderly patients.
Aim of the work is to Compare OFA with Opioid anesthesia (OA) as regards improvement of the surgical field condition in elderly patients undergoing arthroscopic shoulder surgery under general anesthesia.
Hypothesis :
The hemodynamics of the opioid free regimen will provide a better surgical field condition.
- Conditions
- Shoulder Lesions
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called paracetamol, fentanyl
drugs are injected with induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| opioid free (OFA) group | Active comparator | 1000 mg paracetamol + dexmedetomidine 1 µg/kg over 10 min as loading dose and dexamethasone 0.1 mg/kg and lidocaine 1 mg/kg IV bolus Then continuous infusion of dexmedetomidine at a rate of 0.5 µg/kg/h with lidocaine 2 mg/kg/hr and magnesium sulfate 1.5 g/hr during surgery . Receives: Drug: Dexmedetomidine |
| fentanyl (F) group | No intervention | fentanyl 2 µg/kg as loading dose followed by continuous infusion at a rate of 1 µg/kg/h during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in MBP
measuring mean blood pressure
Measured: at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.
Secondary outcomes (5)
change in SBP
measuring systolic blood pressure
Measured: at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.
change in HR
measuring heart rate
Measured: at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.
Grades of surgical field bleeding, correlation between the difference in MAP and the grade of the surgical field.
Grades of surgical field bleeding, correlation between the difference in MAP and the grade of the surgical field.
Measured: 1 minute after visualizing the field with the arthroscope and then every 10 min till the end of surgery
AMT score
AMT score
Measured: after recovery from anesthesia (PACU AMT), 6 hours after surgery (Day-0) and on the next three postoperative days (Day-1, Day-2 and Day-3) at the same time of evaluation on day 0.
Postoperative complications as nausea, vomiting, bradycardia, hypoxia, shivering and delirium
Postoperative complications as nausea, vomiting, bradycardia, hypoxia, shivering and delirium
Measured: within 2 hours in the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start3 Sep 2022
- Primary completion2 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder LesionsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ismail, Cairo University
- Investigators
- Dalia K Ismail, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577117
- Sponsor's protocol ID
- MS-201-2022
- Status last verified
- Nov 2022
- First submitted
- 26 Sep 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol is shared and results and discussions will be shared once statistical analysis is done
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia Versus Opioid Based Anesthesia for Improvement of the Surgical Field Condition in Elderly Patients Undergoing Arthroscopic Shoulder Surgery. A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05577117
- Acronym / sponsor ID
- MS-201-2022
- Conditions
- Shoulder Lesions
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 13 Oct 2022 (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.
Arthroscopic shoulder surgeries are commonly used as a minimally invasive surgery for shoulder diseases. however, it causes moderate-to-severe pain and needs stabilization of hemodynamics, without compromising the patient, to the degree that lessens the intraarticular bleeding to provide adequate visualization by the surgeon owing to inability to use a tourniquet in this situation.
Opioids have known side effects, like respiratory depression, postoperative nausea and vomiting, pruritus, difficulty in voiding, and ileus. These complications may lead to a prolonged hospital stay.
The elderly patients are predisposed to a greater hemodynamic changes due to the higher resting sympathetic tone ,altered beta receptor sensitivity , depleted intravascular volume because of frequent use of diuretics, increased myocardial stiffness ,increased arterial stiffness, reduced sinus node function and baroreceptor responsiveness and other patients comorbidities. So they are at increased risk complications as myocardial infarction, stroke and delirium.
Opioid free anesthesia is a technique with no opioids administered intraoperatively through either systemic, neuraxial, or tissue infiltration routes. The number of case reports and small prospective studies from all over the world supports its benefits.
OFA depends on combinations of non-opioid agents and adjuncts, including lidocaine, magnesium, dexmedetomidine, ketamine,and dexamethasone to produce anesthesia, and analgesia.
Dexmedetomidine is an a2 agonist that possesses anxiolytic, anesthetic, hypnotic, and analgesic properties. In addition, it reduces the pressor responses mediated by the sympathetic nervous system.
Lignocaine is a short-acting amide local anaesthetic agent. It is potent as a sodium channel blocker and has been shown to provide excellent analgesia when administered intravenously . The evidence base supports lignocaine as an analgesic agent, an opioid-sparing agent, an anti-inflammatory and a co-anaesthetic.
n,Complex regional pain syndrome,opioid-tolerant patient and early recovery after surgery, however, few studies focused on its ablility to improve the surgical field condition which depends on the hemodynamics especially in elderly patients.
Aim is to Compare OFA with Opioid anesthesia (OA) as regards improvement of the surgical field condition in elderly patients undergoing arthroscopic shoulder surgery under general anesthesia.
Detailed description
Arthroscopic shoulder surgeries are commonly used as a minimally invasive surgery for shoulder diseases. however, it causes moderate-to-severe pain and needs stabilization of hemodynamics, without compromising the patient, to the degree that lessens the intraarticular bleeding to provide adequate visualization by the surgeon owing to inability to use a tourniquet in this situation.
Controlling the pain in shoulder surgery facilitates early mobilization, fast functional recovery and allows pain-free muscle contraction.
Opioids have known side effects, like respiratory depression, postoperative nausea and vomiting, pruritus, difficulty in voiding, and ileus. These complications may lead to a prolonged hospital stay.
The elderly patients are predisposed to a greater hemodynamic changes due to the higher resting sympathetic tone ,altered beta receptor sensitivity , depleted intravascular volume because of frequent use of diuretics, increased myocardial stiffness ,increased arterial stiffness, reduced sinus node function and baroreceptor responsiveness and other patients comorbidities. So they are at increased risk complications as myocardial infarction, stroke and delirium.
Opioid free anesthesia is a technique with no opioids administered intraoperatively through either systemic, neuraxial, or tissue infiltration routes. The number of case reports and small prospective studies from all over the world supports its benefits.
Initially, OFA depends on combinations of non-opioid agents and adjuncts, including lidocaine, magnesium, dexmedetomidine, ketamine,and dexamethasone to produce anesthesia, and analgesia.
Magnesium is a non-competitive antagonist of N-methyl-D-aspartate (NMDA) and has anti-inflammatory effects because it decreases interleukin 6 (IL-6) and tumour necrosis factor (TNF-alpha) levels postoperatively.
Dexamethasone is a mineraloglucocorticoid that has been shown to be effective as an antiemetic in a number of surgical operations. Dexamethasone was integrated into the multimodal opioid-free approach based on De Oliveira's and others' findings that dosages of> 0.1 mg/kg exhibit clinically significant analgesic characteristics in lean adults.
Ketamine is another non-competitive antagonist of the n-methyl-D-aspartate receptor and is commonly used either as a small bolus of 0.25-0.5 mg/kg IBW or in a low-dose continuous infusion at 2-2.5 μg/kg/min. Schug and others have summarised its benefits in APMSE4 in both the general acute pain population and bariatric patients.
Dexmedetomidine is an a2 agonist that possesses anxiolytic, anesthetic, hypnotic, and analgesic properties. In addition, it reduces the pressor responses mediated by the sympathetic nervous system.
Lignocaine is a short-acting amide local anaesthetic agent. It is potent as a sodium channel blocker and has been shown to provide excellent analgesia when administered intravenously . The evidence base supports lignocaine as an analgesic agent, an opioid-sparing agent, an anti-inflammatory and a co-anaesthetic.
n ,Complex regional pain syndrome ,opioid-tolerant patient and early recovery after surgery , however, few studies focused on its ability to improve the surgical field condition which depends on the hemodynamics especially in elderly patients.
Aim of the work is to Compare OFA with Opioid anesthesia (OA) as regards improvement of the surgical field condition in elderly patients undergoing arthroscopic shoulder surgery under general anesthesia.
Hypothesis :
The hemodynamics of the opioid free regimen will provide a better surgical field condition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid free (OFA) group | Active comparator | Drug: Dexmedetomidine1000 mg paracetamol + dexmedetomidine 1 µg/kg over 10 min as loading dose and dexamethasone 0.1 mg/kg and lidocaine 1 mg/kg IV bolus Then continuous infusion of dexmedetomidine at a rate of 0.5 µg/kg/h with lidocaine 2 mg/kg/hr and magnesium sulfate 1.5 g/hr during surgery . |
| fentanyl (F) group | No intervention | –fentanyl 2 µg/kg as loading dose followed by continuous infusion at a rate of 1 µg/kg/h during surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ASA I or II
- aged > 65 years
- undergoing arthroscopic shoulder surgery under general anesthesia.
Key exclusion criteria (6 listed)
- uncontrolled systemic diseases
- significant organ dysfunctions
- morbid obesity (BMI >35)
- history of allergy to the study drugs
- use of beta blockers
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 |
|---|---|---|
| DexmedetomidineAlso: paracetamol, fentanyldrugs are injected with induction of general anesthesia | Drug | opioid free (OFA) group |
Primary outcome
change in MBP
Time frame: at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.
measuring mean blood pressure
5 secondary outcomes
change in SBP
Time frame: at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.
change in HR
Time frame: at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 hours.
Grades of surgical field bleeding, correlation between the difference in MAP and the grade of the surgical field.
Time frame: 1 minute after visualizing the field with the arthroscope and then every 10 min till the end of surgery
AMT score
Time frame: after recovery from anesthesia (PACU AMT), 6 hours after surgery (Day-0) and on the next three postoperative days (Day-1, Day-2 and Day-3) at the same time of evaluation on day 0.
Postoperative complications as nausea, vomiting, bradycardia, hypoxia, shivering and delirium
Time frame: within 2 hours in the PACU
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 21 Nov 2022.
- Individual participant dataSharing planned: Yes. Study protocol is shared and results and discussions will be shared once statistical analysis is done
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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.
Dalia K Ismail principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexmedetomidine in people with Shoulder Lesions, run by Cairo 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 3 inclusion and 6 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 21 Nov 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
change in MBP (time frame: at start of the study drug infusion (Time1), after intubation (Time2), then every 10 min till the end of surgery. In the PACU will be recorded on arrival, after 30 min, 1 hour, and 2 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 21 Nov 2022.