Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

NCT ID: NCT03453424

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2019-05-30

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.

Conditions

Abdominal Pain; Abdominal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

TEA+DEX group

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

Group Type: ACTIVE_COMPARATOR

TEA+DEX

Intervention Type: PROCEDURE

intra and post operative TEA infusion of (bupivacaine +fentanyl 2 mic/ ml+ dexmedetomidine 0.5 mic/ ml) Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 inter space was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.

TEA group

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

Group Type: ACTIVE_COMPARATOR

TEA

Intervention Type: PROCEDURE

Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 interspace was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.

then, intra and post operative TEA infusion of bupivacaine 0.125%+fentanyl 2 mic/ ml.

Interventions

TEA+DEX

intra and post operative TEA infusion of (bupivacaine +fentanyl 2 mic/ ml+ dexmedetomidine 0.5 mic/ ml) Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 inter space was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.

Intervention Type: PROCEDURE

TEA

Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 interspace was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.

then, intra and post operative TEA infusion of bupivacaine 0.125%+fentanyl 2 mic/ ml.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Egypt Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Alaa Ali M. Elzohry

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa M. Elzohry, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer in Assuit university

Locations

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Asyut, , Egypt

Countries

Egypt

Other Identifiers

SECI

Identifier Type: -

Identifier Source: org_study_id