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Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural

NCT06489574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-08

No results posted yet for this study

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.

Conditions

  • Post-operative Pain
  • Thoracic Epidural
  • Thoracotomy Surgery

Interventions

PROCEDURE

thoracic epidural with dexmedetomidine in patients undergoing thoracotomy surgery

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).

PROCEDURE

thoracic epidural with fentanyl in patients undergoing thoracotomy surgery

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).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • mohamed g soliman, MS · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489574 on ClinicalTrials.gov