Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

Phase 2

Completed

• Conditions: Abdominal Cancer; Abdominal Pain
• Interventions: Procedure: TEA+DEX; Procedure: TEA

• Registration Number: NCT03453424
• Lead Sponsor: South Egypt Cancer Institute

Brief Summary

Dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

Detailed Description

The aim of modern anaesthetic practice is to insure the rapid recovery of patients with fewer complications and earlier hospital discharge.

Thoracic epidural anesthesia (TEA) has been established as a cornerstone in the perioperative care after thoracic and major abdominal surgery providing most effective analgesia. beyond its analgesic properties, TEA's effects on the postoperative neurohumoural stress response, cardiovascular Pathophysiology, and intestinal dysfunction have been in the focus of both clinical and experimental investigations for years.

dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

Study Timeline

• Study Start: 2017-06-30
• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Primary Completion: 2019-05-10
• Study Completion: 2019-05-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• adult patients (21 years old or more),
• classified as American Society of Anesthesiologists (ASA) grade II and III,
• scheduled for elective major abdominal cancer surgery.

Exclusion Criteria

• patients with coagulopathy,
• active neurological disease,
• cutaneous disorders at the epidural insertion site,
• allergy to the study medication
• and patients refusal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEA+DEX group	TEA+DEX	Intra operative thoracic epidural injection of (bupivacaine 0.125% +fentanyl 2 mic/ ml) , initial bolus dose of 8 ml before skin incision followed by fixed rate infusion of 6 ml/h till end of abdominal layer closure. Postoperative, thoracic epidural injection of (bupivacaine 0.0625%+fentanyl 2 mic /ml + dexmedetomidine 0.5 mic/ ml) at infusion rate 6 ml /h and bolus dose of 3 ml with lockout time 10 min
TEA group	TEA	Intraoperative,thoracic epidural injection of bupivacaine (0.125%+fentanyl 5 mic/ml ) ,initial bolus dose of 8 ml before skin incision followed by fixed rate infusion of 6 ml/h till start of abdominal layer closure. Postoperative, thoracic epidural injection of (bupivacaine 0.0625%+fentanyl 2 mic /ml) at infusion rate 6 ml /h and bolus dose of 3 ml with lockout time 10 min

Primary Outcome Measures

Name	Time	Method
Change in pain scores (dynamic VAS)	at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.	dynamic visual analogue scale (0-10) 0=no pain 10=worst imaginable pain

Secondary Outcome Measures

Name	Time	Method
Change in post operative MAP	at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.	Mean arterial pressure

Trial Locations

Locations (1)

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt; 🇪🇬 Assiut, Egypt