Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05943613 |
| Other study ID # |
Clonidine versus Neostigmine |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
November 30, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Assiut University |
| Contact |
yasser mamdouh hassan, assistant lecturer |
| Phone |
01090433083 |
| Email |
yassermamdouh486[@]aun.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The delivery of the infant into the arms of a conscious and pain free mother is one of the
most exciting and rewarding moments in medicine. Neuraxial anesthesia is now the preferred
technique for lower segment cesarean sections (LSCS). Although epidural, spinal, continuous
spinal, and combined spinal-epidural techniques have all been advocated, most cesarean
sections are performed under single-shot spinal anesthesia.
Even when a long acting local anesthetic like bupivacaine is used, the duration of spinal
anesthesia (SA) is short and higher doses of analgesics are required in the postoperative
period. Therefore, achieving a subarachnoid block that provides high quality postoperative
analgesia of consistently prolonged duration is an attractive goal.
Description:
Opioids such as morphine, fentanyl, and sufentanil have been administered intrathecally as
adjuvants to increase the duration of postoperative analgesia. Although they ensure superior
quality of analgesia, they are associated with many side effects such as pruritus, nausea,
vomiting, urinary retention, and especially late and unpredictable respiratory depression.
This has directed the research toward the use of newer and better local anesthetic additives
for SA such as neostigmine, ketamine, midazolam, and clonidine.
Neostigmine is an anticholinesterase agent which increases the acetylcholine (Ach)
concentration at the cholinergic synapse by blocking the activity of true and
pseudocholinesterase enzymes. In postoperative period descending noradrenergic or cholinergic
antinociceptive spinal system is activated by ongoing pain causing an increase in the release
of Ach, which in the presence of neostigmine results in augmented analgesia. It has no
untoward side effects such as respiratory depression, pruritus, and drowsiness as experienced
with intrathecal narcotics.Clonidine is an α2-receptor agonist which has gained popularity in
recent times as an adjuvant in spinal anesthesia. Analgesic effect of clonidine mediated by
α2-adrenoceptors situated in the dorsal horn of spinal cord. The antinociceptive properties
of clonidine indicate that it might be useful as an alternative to intrathecal opioids for
postoperative analgesia, thus also avoiding the adverse effect of opioids.
Neostigmine was used in different dose ranges from 5 µg to 750 µg intrathecally but a low
dose of 5 µg is sufficient to cause early onset of sensory and motor block.
On the other hand, clonidine was used in different doses from 15 µg to 450 µg, and many
previous studies concluded that minimum 30 µg dose of clonidine provide a significant
increase in the duration of sensory block, motor block, and spinal analgesia without
increasing the incidence of side effects.
Dextrose 5% is used to make the adjuvant solutions more hyperbaric because in some studies,
when hyperbaric solution of neostigmine was used, the incidence of nausea and vomiting was
reduced by preventing cephalic spread of the drug to the brain stem.
Stress responses to surgical trauma and postoperative pain elicit diffuse changes in hormonal
secretion such as adrenocorticotropic hormone (ACTH), cortisol and prolactin, with several
deleterious metabolic and cardiovascular effects that can be prevented by effective
postoperative analgesia.
Cortisol is a key player in the stress response and its secretion is facilitated by the ACTH
which interacts with the sympathetic nervous system and the inhibitory control of endogenous
opioid peptides, influencing pain processing.(12) Negative associations between cortisol
levels and subsequent pain perception suggest the possibility that the
hypothalamic-pituitary- adrenal (HPA) axis contributes to attenuating pain perception during
acute stressful events, possibly mediated by increased cortisol.
