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Fentanyl vs Dexmedetomidine for Arthriscopic Shoulder Intervention in Elderly.

NCT05577117 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-11-21

No results posted yet for this study

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.

Conditions

  • Shoulder Lesions

Interventions

DRUG

Dexmedetomidine

drugs are injected with induction of general anesthesia

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Dalia K Ismail · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-03
Primary Completion
2022-11-02
Completion
2022-11-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05577117 on ClinicalTrials.gov