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NCT Number: NCT03453424

Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

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

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Key information

Conditions

Abdominal Pain Abdominal Cancer Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEA+DEX

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

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.

Primary outcomes

  1. Change in pain scores (dynamic VAS)

    Time frame: 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 outcomes

  1. Change in post operative MAP

    Time frame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.

    Mean arterial pressure

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2018
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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