Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02861716 |
| Other study ID # |
Prospective |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
July 29, 2016 |
| Last updated |
April 8, 2018 |
| Start date |
August 2016 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
April 2018 |
| Source |
South Egypt Cancer Institute |
| Contact |
khaled fares, professor |
| Phone |
002/01289757288 |
| Email |
faressali[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
- Vital signs (heart rate, noninvasive arterial blood pressure, oxygen saturation and
respiratory rate) immediately postoperative (0 hour) and at 2, 4, 6, 8, 12,18 and 24
hours of the postoperative period.
- The face, Legs, Activity, Crying, and Consolability (FLACC) pain score with its 0- 10
score range will be used to assess pain immediately postoperative and at 2, 4, 6, 12,
18, 24 hours postoperative.
- The time of first request for analgesia (Intravenous paracetamol 20mg/kg (perfalgan ®)
which will be given when the FLA CC score ≥4 and total paracetamol consumption also will
be recorded in the 24 hours postoperative.
- The level of sedation will be recorded using Ramsey sedation scale as the same time
points of FLA CC score.
- Postoperative adverse effects such as nausea, vomiting, itching, hypo-tension,
bradycardia, arrhythmia and respiratory depression (respiratory depression will be
defined as decreased Spo2of less than 95% or respiratory rate less than 10 per minute)
will be treated and recorded.
