Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05577117 |
| Other study ID # |
MS-201-2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
September 3, 2022 |
| Est. completion date |
November 10, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
