CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
thoracic epidural with dexmedetomidine in patients undergoing thoracotomy surgery +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06489574
NCT06489574N/ACompleted

A Comparison Between Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural in Patients Undergoing Thoracotomy Surgery: A Randomized Controlled Trial

Cairo University·interventional·Posted Jul 8, 2024·Updated Jul 8, 2024

In Brief

A clinical study evaluating thoracic epidural with dexmedetomidine in patients undergoing thoracotomy surgery and thoracic epidural with fentanyl in patients undergoing thoracotomy surgery for Post-operative Pain and 2 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

To find out if there is a benefit from adding dexmedetomidine to epidural bupivacaine as regards: * Intra and postoperative opioid consumption * Pain score (numerical rating scale) * Hemodynamic stability, * Patient satisfaction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 8, 2024
Enrollment StartJan 1, 2023
Primary CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.0 years ago

Interventions

thoracic epidural with dexmedetomidine in patients undergoing thoracotomy surgeryprocedure

A thoracic epidural catheter will be inserted at the T6- T7 intervertebral space, with the patient in the sitting position with standard aseptic precautions using an 18-G Touhy needle via a midline or paramedian approach with a loss of resistance method. A test dose of 3 ml of 2% lignocaine with adrenaline 5 µ/ml will be administered. For thoracic surgery the sensory dermatome blockade needs to cover the incision and intercostal drains and may extend from T4 to T8. The epidural drug will be administered according to the group allocation over a period of 10 minutes as follows: Group A: Patients will receive 50 μg dexmedetomidine with 10 ml of 0.125% bupivacaine followed by a continuous infusion of (10 ml bupivacaine + 25 μg dexmedetomidine + 39 ml saline with rate of 5 ml per hour).

thoracic epidural with fentanyl in patients undergoing thoracotomy surgeryprocedure

A thoracic epidural catheter will be inserted at the T6- T7 intervertebral space, with the patient in the sitting position with standard aseptic precautions using an 18-G Touhy needle via a midline or paramedian approach with a loss of resistance method. A test dose of 3 ml of 2% lignocaine with adrenaline 5 µ/ml will be administered. For thoracic surgery the sensory dermatome blockade needs to cover the incision and intercostal drains and may extend from T4 to T8. The epidural drug will be administered according to the group allocation over a period of 10 minutes as follows: Group B: Patients will receive 50 μg fentanyl in addition to 10 ml 0.125% bupivacaine followed by a continuous infusion (10 ml bupivacaine + 100 μg fentanyl + 38 ml saline with rate of 5 ml per hour).