Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489574
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2023-09-22
Brief Title:
Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
A Comparison Between Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural in Patients Undergoing Thoracotomy Surgery A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
adjuvants
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
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 µml 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 0125 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 0125 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 mgkg together with fentanyl 2 mgkg until loss of verbal response Muscle relaxation will be achieved with atracurium 05 mgkg and the patients 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 03 - 05 mgkghr
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 02 mgkg IV and administering IV 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 mickg up to 3 mickg maximum dose
Bradycardia heart rate 50 beatsmin will be managed by atropine 002 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 mgkg every 8 hours and NASID 05 - 2kg day divided in 2 doses will be administered IV
Pain will be assessed using the numerical rating scale NRS and if the pain score is more than 3 3mg morphine IV will be administrated intra venous as rescue analgesia up to 4 mgkg morphine maximum dose every 24 Hours
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 µml 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 0125 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 0125 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 mgkg together with fentanyl 2 mgkg until loss of verbal response Muscle relaxation will be achieved with atracurium 05 mgkg and the patients 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 03 - 05 mgkghr
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 02 mgkg IV and administering IV 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 mickg up to 3 mickg maximum dose
Bradycardia heart rate 50 beatsmin will be managed by atropine 002 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 mgkg every 8 hours and NASID 05 - 2kg day divided in 2 doses will be administered IV
Pain will be assessed using the numerical rating scale NRS and if the pain score is more than 3 3mg morphine IV will be administrated intra venous as rescue analgesia up to 4 mgkg morphine maximum dose every 24 Hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None