Opioid Free Anesthesia in Shoulder Arthroscope

NCT06834854 | Completed Phase 1

• 1 other identifier: FMASU MS149/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will assess opioid free anesthesia technique as regards effectiveness \& duration of post operative analgesia in shoulder arthroscpe surgeries

Conditions

Measure Time to First Rescue Analgesia Following Extubation

Outcome Measures

Primary Outcomes (1)

• Measure time to first rescue analgesia following extubation

  24 hour post-extubation

Secondary Outcomes (2)

• Total postoperative analgesia consumption during the 24 hours following extubation

  24 hour post-extubation

• Postoperative pain score for 24 hours using the Visual Analogue Scale (VAS): 30 min after recovery, hourly for 2 h and every 6 h for 24 h

  24 hour post-extubation

Study Arms (2)

opioid-anesthesia group (OA group)(control group)

ACTIVE COMPARATOR

Drug: fentanyl

opioid free anesthesia group (OFA group)

ACTIVE COMPARATOR

Drug: Lidocaine (drug)

Interventions

fentanyl DRUG

Induction: After pre-oxygenation with 100% oxygen, anesthesia will be induced with propofol 2mg/kg (1 ampoule contains 200 mg in 20cc syringe), 100 ml of isotonic saline over 15 minutes. Fentanyl 1 mcg/kg (1 ampoule contains 100mcg over 10cc syringe). Cis-atracurium 0.2 mg/kg (1ampoule contains 20mg in 10cc syringe) will be administered and endotracheal intubation will be done Maintenance: Anesthesia will be maintained with Isoflurane 1-1.5 % in oxygen and air mixture 1:1, and cis-atracurium will be administered in incremental doses of 0.03mg/kg/30min. Another IV cannula will be placed with two infusion pumps of normal saline 50cc and fentanyl infusion 1-2 mcg/kg/hour (max 300 mcg total).

opioid-anesthesia group (OA group)(control group)

Lidocaine (drug) DRUG

Induction: After pre-oxygenation with 100% oxygen, anesthesia will be induced with IV propofol 2mg/kg (1 ampoule contains 200 mg in 20cc syringe), lidocaine 2% (1.5 mg/kg (7.5cc bolus dose)), MgSO4 10% (50 mg/kg in 100 ml of isotonic saline over 15 minutes), Cis-atracurium 0.2 mg/kg (1ampoule contains 20mg in 10cc syringe) will be administered and endotracheal intubation will be done. Maintenance: Anesthesia will be maintained using Isoflurane 1-1.5 % in oxygen and air mixture 1:1, and cis-atracurium will be administered in incremental doses of 0.03 mg/kg/30min. Another IV cannula will be placed with 2 infusion pump one of them containing mixture of (lidocaine 2% 1.5 mg/kg/hour as infusion along with MgSO4 10% in 10-15 mg/kg/hour with 50cc normal saline over 50ml/hour), while the second contains propofol at 6-10 mg/kg/hour.

opioid free anesthesia group (OFA group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group: 18-65 years old Undergoing a scheduled shoulder arthroscope

You may not qualify if:

• Allergies to any of the study drugs. Severe bradycardia or uncontrolled hypertension preoperatively. Renal failure. Hepatic failure. Cerebral insufficiency. Pregnant or breastfeeding women. Patients' refusal to participate in the study ASA physical status class \> 3

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt, 11111, Egypt

Location

MeSH Terms

Interventions

Fentanyl; Lidocaine; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: March 12, 2024
• Primary Completion: August 15, 2024
• Study Completion: September 15, 2024
• Last Updated: February 19, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: free

Locations

EG (1)