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Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06489574
Acronym
adjuvants
Enrollment
50
Registered
2024-07-08
Start date
2023-01-01
Completion date
2024-02-29
Last updated
2024-07-08

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

Conditions

Post-operative Pain, Thoracic Epidural, Thoracotomy Surgery

Keywords

Thoracotomy, Dexmedetomidine, Thoracic Epidural, Fentanyl

Brief 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.

Detailed description

Following approval from Research Committee of Anesthesia Department and the Ethics Committee of the Faculty of Medicine, Cairo University, 50 patients will be included in the study (25 patients per group). After obtaining written informed consents, all patients will be subjected to systematic preoperative assessment including history taking, physical examination, and review of the results of routine investigations. Upon arrival to the preparation room, a 20G IV cannula will be inserted into a peripheral vein and midazolam 2-3 mg will be administered unless contraindicated. A 20G arterial catheter will be inserted into the radial artery of the dependent (non-operative) side, after local infiltration with lidocaine 2%. Patients will be transferred to the operating room where routine monitoring is applied, including electrocardiography (ECG), invasive Blood Pressure (IBP) and pulse oximetry are attached. Baseline heart rate, blood pressure, oxygen saturation and respiratory rate will be recorded. 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). 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). After documenting the sensory blockade by using a piece of ice or cold object, If sensory level fail to be achieved, patient will be out of the study. Anesthesia will be induced with Propofol 2-3 mg/kg, together with fentanyl 2 mg/kg until loss of verbal response. Muscle relaxation will be achieved with atracurium 0.5 mg/kg and the patient's trachea will be intubated using a single or double-lumen tube, as indicated by the surgical procedure. Anesthesia will be maintained by isoflurane, and muscle relaxation will be maintained with atracurium 0.3 - 0.5 mg/kg/hr. The lungs will be ventilated with positive pressure ventilation to maintain end-tidal carbon dioxide (EtCO2) between 32 and 36 mmHg. Patients' heart rate, blood pressure will be monitored continuously and recorded at ten-minute intervals until the end of surgery. Any attack of hypotension, defined as a drop of \> 20% of baseline blood pressure, will be managed by ephedrine 0.2 mg/kg IV, and administering I.V. fluids. On the other hand, hypertension, defined as an increase of \> 20 % of baseline blood pressure, will be managed by increasing the depth of anesthesia and administering bolus doses of fentanyl 1 mic/kg (up to 3 mic/kg maximum dose). Bradycardia (heart rate \< 50 beats/min) will be managed by atropine 0.02 mg/ kg IV At the end of surgery residual neuromuscular blockade will be reversed and the endotracheal tube will be removed. Patients will be transferred to the ICU and will be monitored for 24 hours. Patients' heart rate, blood pressure, oxygen saturation and respiratory rate will be monitored at regular intervals and the pain score and sedation level as well. Epidural infusion will be continued with the same infusion rate. A fixed dose of paracetamol (10 - 15 mg/kg) every 8 hours and NASID (0.5 - 2/kg/ day divided in 2 doses will be administered I.V. Pain will be assessed using the numerical rating scale (NRS) and if the pain score is more than 3, 3mg morphine I.V. will be administrated intra venous as rescue analgesia (up to .4 mg/kg morphine maximum dose every 24 Hours).

Interventions

PROCEDUREthoracic 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).

PROCEDUREthoracic 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

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Patients will be randomized using a computer-generated list of random numbers, which will be sealed in closed envelopes. Patients will be randomly allocated to one of two groups; Group I will receive dexmedetomidine, while Group II (R) will receive fentanyl. An anesthesiologist who is not involved in the data collection team will perform all thoracic epidural infusion. Intra- and postoperative data will be collected by an anesthesiologist or intensivist who is blinded to the study protocol. So, both the patients and data collector were blinded to group assignment.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18 - 60 years old * ASA physical status I-II-III * Good mental function. * Patient scheduled for thoracic surgery with posterolateral thoracotomy. * BMI of patient (18 - 30).

Exclusion criteria

* Age less than 18 or more than 60 years old * Any contraindications to epidural injection (patient refusal, local infection at the site of injection, coagulopathy, patients on anticoagulant or antiplatelet drugs, known allergy to local anesthetics, significant spine deformity) * Inability to provide informed consent or pain score

Design outcomes

Primary

MeasureTime frameDescription
Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups24 hoursDexmedetomidine compared to fentanyl as adjvant for thoracic epidural for post operative analgesia

Secondary

MeasureTime frameDescription
heart rate (beat/ minute)Intraoperativewill be recorded at baseline, ten and twenty minutes after epidural activation, immediately after induction, and every 10 minutes till end of surgery
Diastolic arterial blood pressure in millimetre mercuryIntraoperativewill be recorded at baseline, ten and twenty minutes after epidural activation, immediately after induction, and every 10 minutes till end of surgery
mean blood pressure n millimetre mercuryIntraoperativewill be recorded at baseline, ten and twenty minutes after epidural activation, immediately after induction, and every 10 minutes till end of surgery
Systolic arterial blood pressure in millimetre mercuryIntraoperativewill be recorded at baseline, ten and twenty minutes after epidural activation, immediately after induction, and every 10 minutes till end of surgery
First request of analgesia postoperative24 Hours post operativeThe elapsed time from the start of thoracic epidural infusion until the administration of the first postoperative rescue analgesia in hours
Patient Satisfaction with Epidural Infusion24 hoursPatient 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
Incidence of side effects24 hours(nausea, vomiting, shivering, hypotension, dizziness, dry mouth, and respiratory depression)
Pain Score According to Numerical Rating Scale (NRS)24 HoursThe 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).

Countries

Egypt

Outcome results

None listed

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