Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

South Egypt Cancer Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Abdominal Cancer; Abdominal Pain

Treatments: Procedure: TEA; Procedure: TEA+DEX

Study type: Interventional

Funder types: Other

Identifiers

NCT03453424

SECI

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

TEA+DEX group

Active Comparator group

Description:

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

Treatment:

Procedure: TEA+DEX

TEA group

Active Comparator group

Description:

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

Treatment:

Procedure: TEA