Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural
NCT Number: NCT06489574
Acronym: adjuvants
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post-operative Pain|Thoracic Epidural|Thoracotomy Surgery
Interventions: PROCEDURE: thoracic epidural with dexmedetomidine in patients undergoing thoracotomy surgery|PROCEDURE: thoracic epidural with fentanyl in patients undergoing thoracotomy surgery
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-01-01
Completion Date: 2024-02-29
Locations: Faculty of Medicine, Cairo University, Cairo, Egypt

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.

Primary Outcome Measures: Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups, Dexmedetomidine compared to fentanyl as adjvant for thoracic epidural for post operative analgesia, 24 hours
Secondary Outcome Measures: Systolic arterial blood pressure in millimetre mercury, will be recorded at baseline, ten and twenty minutes after epidural activation, immediately after induction, and every 10 minutes till end of surgery, Intraoperative|heart rate (beat/ minute), will be recorded at baseline, ten and twenty minutes after epidural activation, immediately after induction, and every 10 minutes till end of surgery, Intraoperative|Diastolic arterial blood pressure in millimetre mercury, will be recorded at baseline, ten and twenty minutes after epidural activation, immediately after induction, and every 10 minutes till end of surgery, Intraoperative|mean blood pressure n millimetre mercury, will be recorded at baseline, ten and twenty minutes after epidural activation, immediately after induction, and every 10 minutes till end of surgery, Intraoperative|Pain Score According to Numerical Rating Scale (NRS), The pain score will be assessed using the NRS, where patients will rate their pain on a scale from 0 to 10. The NRS value will be obtained from the patient immediately after recovery from anesthesia and then every 4 hours during the first 24 hours postoperatively.

Minimum Value: 0 (no pain) Maximum Value: 10 (worst possible pain) Interpretation: Higher scores indicate worse outcomes (more severe pain)., 24 Hours|First request of analgesia postoperative, The elapsed time from the start of thoracic epidural infusion until the administration of the first postoperative rescue analgesia in hours, 24 Hours post operative|Patient Satisfaction with Epidural Infusion, Patient satisfaction will be assessed using a validated satisfaction survey immediately after the procedure. The survey will include questions rated on a Likert scale from 1 to 5, where 1 indicates "very dissatisfied" and 5 indicates "very satisfied." Minimum Value: 1 (very dissatisfied) Maximum Value: 5 (very satisfied) Interpretation: Higher scores indicate greater satisfaction with the procedure, 24 hours|Incidence of side effects, (nausea, vomiting, shivering, hypotension, dizziness, dry mouth, and respiratory depression), 24 hours