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Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

Primary Purpose

Abdominal Pain, Abdominal Cancer

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
TEA+DEX
TEA
Sponsored by
South Egypt Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TEA+DEX group

TEA group

Arm 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

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

Outcomes

Primary Outcome Measures

Change in pain scores (dynamic VAS)
dynamic visual analogue scale (0-10) 0=no pain 10=worst imaginable pain

Secondary Outcome Measures

Change in post operative MAP
Mean arterial pressure

Full Information

First Posted
February 21, 2018
Last Updated
March 19, 2020
Sponsor
South Egypt Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03453424
Brief Title
Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA
Official Title
Analgesic Efficacy of Dexmedetomidine Added to Patient Controlled Epidural Analgesia for Patients Undergoing Major Abdominal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Abdominal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEA+DEX group
Arm Type
Active Comparator
Arm 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
Arm Title
TEA group
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
TEA+DEX
Intervention Description
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
Intervention Name(s)
TEA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain scores (dynamic VAS)
Description
dynamic visual analogue scale (0-10) 0=no pain 10=worst imaginable pain
Time Frame
at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Secondary Outcome Measure Information:
Title
Change in post operative MAP
Description
Mean arterial pressure
Time Frame
at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M. Elzohry, MD
Organizational Affiliation
Lecturer in Assuit university
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

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