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Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03453424
Enrollment
90
Registered
2018-03-05
Start date
2017-06-30
Completion date
2019-05-30
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Abdominal Cancer

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.

Interventions

PROCEDURETEA+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.

PROCEDURETEA

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.

Sponsors

South Egypt Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scores (dynamic VAS)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

MeasureTime frameDescription
Change in post operative MAPat 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.Mean arterial pressure

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026