Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05470530 |
| Other study ID # |
FMASU MS 179/2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2022 |
| Est. completion date |
July 15, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare the the effect of intravenous and the intrathecal
dexamethasone when added to spinal anesthesia in cesarean section.
Description:
1. Pre-operative settings:
Detailed preoperative examination and preoperative investigations (complete blood
picture, Bleeding Time, prothrombin time and partial thromboplastin time) were
performed. Age and weight were recorded. The patient was fasting for 8 hours
preoperatively.
In the preanesthetic room, 18-gauge intravenous cannula was sited. Patients was
preloaded with 5 mL/kg of lactated Ringer's solution over 20 minutes. The visual
analogue scale (VAS) for pain was explained to the patients
2. Intra-operative Settings Inside the operating room, mean arterial blood pressure (MAP),
heart rate (HR), electrocardiography (ECG) and peripheral oxygen saturation (SpO2) were
obtained using standard non-invasive monitors and base line values were recorded.
The spinal technique was performed under complete aseptic condition with the patient in
sitting position at the L3- L4 or L4 -L5 intervertebral space with 25-gauge spinal needle
through midline approach. The spinal drugs were administered over 30 second according to each
group.
Groups:
The eligible patients were enrolled in this double blinded study and randomly allocated to
one of three groups by computer generated random number lists. The allocation was concealed
using closed opaque envelopes. The solution for intrathecal injection was prepared by an
anesthesiologist who did not have a further role in the study.
Control group (n= 22): Participants were received normal saline 2 mL intravenously with
intrathecal injection of heavy bupivacaine 0.5% 2 mL (10mg) plus 1 mL of 0.9% saline, overall
3 ml volume intrathecally (Pyasetska, 2020).
IT group (n= 22): Participants were received normal saline 2 mL intravenously with
intrathecal injection of heavy bupivacaine 0.5% 2 mL (10mg) plus 0.5 mL (2mg) dexamethasone
diluted in 0.5 ml of 0.9% saline, overall 3 ml volume intrathecally. The dose of 2mg of
dexamethasone was demonstrated by Amer (2018) to be the least effective intrathecal dose.
IV group (n= 22): Participants were received dexamethasone 2 mL (8mg) intravenously with
intrathecal injection of heavy bupivacaine 0.5% 2 mL plus 1 mL of 0.9% saline (Pyasetska,
2020).
After completing the intrathecal injection, the patient was immediately placed in the supine
position IV Ringer's solution 10 ml/kg/hour was administered throughout the surgery. Oxygen
was administered through a nasal cannula in a rate of 2 L/min.
Measurements:
Sensory block was assessed according to loss of sensation using cold alcohol swab every two
minutes after completing the spinal injection. Time to reach the sensory level of T10 was
recorded to determine the effect of the drug on the onset of the spinal anesthesia.
Spinal anesthesia was considered adequate to undergo surgery if the sensory level reaches a
T4 level, otherwise the patients were excluded from the study, recorded as "excluded due to
low level" and replaced by another patient to achieve the required sample size.
The highest level reached within 30 min, and its time, were recorded. Hemodynamic parameters
(heart rate and mean arterial pressure) and SpO2 were measured and recorded just after
performing spinal anesthesia, and at 10 min interval till the end of the surgery.
Bradycardia, defined as a heart rate decrease more than 20% of the baseline (preoperative)
value, will be treated by atropine 0.6 mg IV.
Hypotension, defined as a decrease in MAP more than 20% of the baseline value, will be
treated by IV ephedrine 3 mg IV increments.
Episodes of bradycardia and hypotension and doses of administered drugs for treatment were
recorded.
A decrease of SpO2 below 92% was treated by increasing the oxygen flow rate and management of
the airway if necessary. The occurrence of this event was recorded.
Occurrence of side effects as nausea, vomiting, itching or shivering were recorded.
Time to two-segment regression of the sensory block from the highest level. The level was
assessed every 10 minutes, after reaching the highest sensory level, by loss of sensation to
cold alcohol swab. This time was considered as the duration of the sensory block
