Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural (adjuvants)

July 3, 2024 updated by: mohamed gamal solimn, Cairo University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: thoracic epidural with dexmedetomidine
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 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).
Experimental: thoracic epidural with fentanyl
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)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups
Time Frame: 24 hours
Dexmedetomidine compared to fentanyl as adjvant for thoracic epidural for post operative analgesia
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic arterial blood pressure in millimetre mercury
Time Frame: Intraoperative
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)
Time Frame: Intraoperative
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
Time Frame: Intraoperative
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
Time Frame: Intraoperative
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)
Time Frame: 24 Hours

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
Time Frame: 24 Hours post operative
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
Time Frame: 24 hours
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
Time Frame: 24 hours
(nausea, vomiting, shivering, hypotension, dizziness, dry mouth, and respiratory depression)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: mohamed g soliman, MS, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-249-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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