Fentanyl vs Dexmedetomidine for Arthriscopic Shoulder Intervention in Elderly.

NCT ID: NCT05577117

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-03
• Study Completion Date: 2022-11-10

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

opioid free (OFA) group

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 .

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

drugs are injected with induction of general anesthesia

fentanyl (F) group

fentanyl 2 µg/kg as loading dose followed by continuous infusion at a rate of 1 µg/kg/h during surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexmedetomidine

drugs are injected with induction of general anesthesia

Intervention Type: DRUG

Other Intervention Names

paracetamol; fentanyl

Eligibility Criteria

Inclusion Criteria

• ASA I or II
• aged > 65 years
• undergoing arthroscopic shoulder surgery under general anesthesia.

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dalia Ismail

Lecturer of Anesthesia, Surgical ICU and pain management at Faculty of medicine Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dalia K Ismail

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of medicine Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-201-2022

Identifier Type: -

Identifier Source: org_study_id