Fentanyl vs Dexmedetomidine for Arthriscopic Shoulder Intervention in Elderly.

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.

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Lesions
• Intervention / Treatment: Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Medicine Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 .	Drug: Dexmedetomidine; drugs are injected with induction of general anesthesia; Other Names: paracetamol; fentanyl
No Intervention: fentanyl (F) group; fentanyl 2 µg/kg as loading dose followed by continuous infusion at a rate of 1 µg/kg/h during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in MBP	measuring mean blood pressure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in SBP	measuring systolic blood pressure	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	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.	1 minute after visualizing the field with the arthroscope and then every 10 min till the end of surgery
AMT score	AMT score	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	within 2 hours in the PACU

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Dalia K Ismail, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2022
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: MS-201-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study protocol is shared and results and discussions will be shared once statistical analysis is done
• IPD Sharing Time Frame: Data should be available within 1 to 2 months
• IPD Sharing Access Criteria: Open
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No