Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

Abdominal Pain Clinical Trial

Official title:

Analgesic Efficacy of Dexmedetomidine Added to Patient Controlled Epidural Analgesia for Patients Undergoing Major Abdominal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453424
• Other study ID #: SECI
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 30, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: March 2020
• Source: South Egypt Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 30, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Cancer
• Abdominal Pain

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain scores (dynamic VAS)	dynamic visual analogue scale (0-10) 0=no pain 10=worst imaginable pain	at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Secondary	Change in post operative MAP	Mean arterial pressure	at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.