Fentanyl vs Dexmedetomidine for Arthriscopic Shoulder Intervention in Elderly.

NCT05577117 | Completed Early Phase 1

• 1 other identifier: MS-201-2022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• change in SBP

  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

  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.

  1 minute after visualizing the field with the arthroscope and then every 10 min till the end of surgery

• 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

  within 2 hours in the PACU

Study Arms (2)

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 .

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.

Interventions

Dexmedetomidine DRUG

drugs are injected with induction of general anesthesia

Also known as: paracetamol, fentanyl

opioid free (OFA) group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Acetaminophen; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines

Study Officials

• Dalia K Ismail

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and pain management at Faculty of medicine Cairo University

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 13, 2022
• Study Start: September 3, 2022
• Primary Completion: November 2, 2022
• Study Completion: November 10, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data should be available within 1 to 2 months
• Access Criteria: Open

Locations

EG (1)