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In this study the investigators aim to determine the analgesic effect and side effects of intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric patients undergoing major abdominal cancer surgeries.
After obtaining approval of the local ethics committee of South Egypt Cancer Institute, Assiut University, Assiut, Egypt, and parent's written informed consent, a randomized double -blinded prospective study will be conducted on (60) pediatric patients.
After applying standard monitors; Pulse oximetry (Spo2), Noninvasive arterial blood pressure, Electrocardiography (ECG), pre-medication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam (0.01 mg/kg), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask and neuromuscular blockade (atracurium besylate 0.5mg/kg) will be used to facilitate endotracheal intubation. After that an intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.
After securing the tube in place, patients will be placed in lateral decubitus position and intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany).
Children will be randomly allocated into 3 groups by using opaque sealed envelopes containing a computer generated randomization schedule. The opaque sealed envelopes are sequentially numbered that will be opened before application of anesthetic plan and each group will include (20) patients:
Group (1): children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg in 2ml volume; it will be injected slowly.
Group (2): children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg plus fentanyl 0.2 μg/kg in 2ml volume; it will be injected slowly.
Group (3): children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg plus dexmedetomidine 0.2 μg/kg in 2ml volume; it will be injected slowly.
Anesthesia will be maintained with oxygen, sevoflurane, atracurium besylate (0.15mg/kg) as muscle relaxant and controlled mechanical ventilation. The inhaled concentration of sevoflurane will be adjusted to achieve hemodynamic changes< 30% of the baseline values. No other narcotics, analgesics or sedatives will be administrated intra-operatively.
During surgery, children will receive lactated ringer's solution 6ml/kg/hr, whereas dextrose 50mg/ml in Nacl 4.5mg/ml will be infused at 4ml/kg/hr in the postoperative period.
Heart rate (HR), noninvasive arterial blood pressure (systolic, and diastolic), oxygen saturation (Spo2) will be recorded at baseline (pre-operatively) and every 10 minutes intra-operative till the end of the operation. The occurrence of intra-operative hypo-tension requiring a fluid bolus, and bradycardia requiring atropine will be recorded.
At the end of the surgery, the residual neuromuscular blocking will be reversed using a mixture of atropine (0.02mg/kg) and neostigmine (0.05mg/kg).
Then after extubation, patients will be transmitted to the post anesthesia care unit (PA CU), and will be followed up by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fentanyl and dexmedetomidine | Experimental | intrathecal bupivacaine (0.5%) 0.4mg/kg plus fentanyl and dexmedetomidine in 2ml volume will be injected slowly over 20 seconds. |
|
| dexmedetomidine and placebo for fentanyl | Active Comparator | intrathecal bupivacaine (0.5%) 0.4mg/kg plus dexmedetomidine 0.2 μg/kg in 2ml volume and placebo (for fentanyl 0.2 μg/kg) it will be injected slowly over 20 seconds. |
|
| fentanyl and placebo for dexmedetomidine | Active Comparator | intrathecal bupivacaine (0.5%) 0.4mg/kg plus fentanyl 0.2 μg/kg in 2ml volume and placebo (for dexmedetomidine 0.2 μg/kg) it will be injected slowly over 20 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery. After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight in 2ml volume and it will be injected slowly over 20 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain by Face, Legs, Activity, Crying, and Consolability (FLACC) Pain Score | FLA CC pain score will be assessed immediately postoperative and then every 2 hours. Each item is scored 0 to 2, yielding a total between 0 and10 | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of pain | return of any pain during the specified post-dose period | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| khaled fares, professor | Contact | 002/01289757288 | faressali@yahoo.com | |
| sahar Mohammed, professor | Contact | 002/01003611410 | drsaher2008@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| rania abdelemam, lecturer | South Egypt Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Egypt Cancer Institute | Recruiting | Asyut | 5555 | Egypt |
De-identified individual participant data for all primary outcome measures will be made available within 6 months of study completion
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| Fentanyl | Drug | premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery. After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight plus fentanyl 0.2 μg/kg in 2ml volume and it will be injected slowly over 20 seconds. |
|
| Dexmedetomidine | Drug | premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery. After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight plus dexmedetomidine 0.2 μg/kg in 2ml volume and it will be injected slowly over 20 seconds. |
|
|
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |