Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04539314 |
| Other study ID # |
274:7/2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
December 30, 2020 |
Study information
| Verified date |
July 2023 |
| Source |
Minia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
the present study was designed to compare the efficacy and safety of two different doses of
dexmedetomidine as an adjuvant to bupivacaine in unilateral TAP block in pediatric patients
undergoing lower abdominal surgery.
Description:
After insertion of venous access, all children received premedication in the form of atropine
at a dose of 0.01-0.02 mg/kg. Perioperative monitoring included continuous ECG, pulse
oximetry and non-invasive arterial blood pressure. Baseline reading of heart rate, mean
arterial blood pressure was recorded after monitor attachment.
General anesthesia will be induced using propofol 1.5-2.5 mg/kg over 20-30 s as tolerated,
atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained
using isoflurane (1 MAC) and atracurium 0.1 mg/kg supplements will be given to maintain
muscle relaxation.
TAP block will be performed in All patients immediately after induction patients will be
allocated randomly into three equal groups, 30 patients in each as the following.
Group 1 (control group) TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%)
Group 2 We will carry out TAP block using the same dose of bupivacaine in the control group
plus dexmedetomidine 0.5 μg / kg as an adjuvant Group (3) In this participants
dexmedetomidine in dose 1 μg / kg will be given as an adjuvant to the control dose of
bupivacaine in the TAP block TAP block procedure With the patient in the supine position, the
site of the ultrasound and needle entry was sterilized. The TAP block will be performed
laterally behind the midaxillary line between the iliac crest and the most inferior extent of
the ribs. The plane between the internal oblique and transversus abdominis muscle located
around the midaxillary line with the probe transverse to the abdomen. Anteriorly, the needle
passes to come perpendicular to the ultrasound beam and placed between transversus and
internal oblique posterior to the midaxillary line. Then, the local anesthetic will be
injected. (Al-Sadek et al.,2014).
The procedure will be performed immediately after induction of anesthesia by candidate
anesthesiologist who is not aware of group allocation.
After completion of surgical procedure anesthesia will be discontinued, muscle relaxant
reversed using atropine 0.02 mg/kg and 0.05 mg/kg of neostigmine, extubated, and transferred
to PACU.
Parameters will be assessed
• Quality of analgesia will be assessed immediately postoperatively and then at 2, 4, 8, 12
and 24 h postoperatively using FLACC scale (face,leg,activity,cry and consolability).
Time to the first analgesic requirement will be recorded from immediately postoperative to
the time of FLACC score >6. Acetaminophen (perfalgan) 15 mg/kg IV will be given as rescue
analgesia for patients if FLACC score >6 and total dose of acetaminophen will be recorded.
• Hemodynamic data including heart rate (HR) and mean arterial blood pressure (MAP).
Intraoperative any increase in heart rate and or mean arterial blood pressure by more than
20% of baseline values in response to surgical stimulus or thereafter throughout the whole
operation warranted administration of intravenous fentanyl (0.5 μg/kg).
- postoperative complication including postoperative hypotension or bradycardia (decrease
in MAP or HR by more than 20% of baseline value), postoperative nausea and vomiting
(PONV)
- length of hospital stays, and patients or parents' satisfaction assessed on a 5-point
scale (Al-Sadek et al.,2014) 1-completely dissatisfied, 2-dissatisfied, 3-not satisfied
nor dissatisfied, 4- satisfied 5-completely satisfied
