Intrathecal, Mirtazapine, Morphine, Nausea, Prophylactic, Vomiting
Conditions
Brief summary
The aim of this work was to evaluate the role of prophylactic mirtazapine and different doses of intrathecal morphine in preventing nausea and vomiting.
Detailed description
It is common practice to provide intrathecal morphine to alleviate postoperative pain because of its powerful and long-lasting analgesic effects. Mirtazapine is a noradrenergic and specific serotonergic antidepressant. It is anxiolytic by its antagonist of the 5HT2 receptor and is strongly sleep-inducing. Its antagonist at 5-hydroxytryptamine subtype 3 (5-HT3) receptor may help to prevent nausea and vomiting
Interventions
DRUGMirtazapine + Bupivacaine + Morphine
Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5% along with 0.2 mg of morphine.
DRUGPlacebo + Bupivacaine + Morphine
Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.2 mg of morphine.
DRUGPlacebo+ Bupivacaine + Morphine
Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-40 years. * American Society of Anesthesiologists (ASA) physical status I-II. * Scheduled for caesarean section under spinal anesthesia
Exclusion criteria
* Known hypersensitivity to mirtazapine. * Gastrointestinal illness. * Diabetes mellitus. * Use of opioids or any medication with known antiemetic properties within 48 hours before surgery. * Mental disorders. * Spinal anesthesia contraindications. * Taking antidepressants or antipsychotic medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting | 24 hours postoperatively | Incidence of postoperative nausea and vomiting was recorded at 3, 6, 12, 18, 24 hours postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 24 hours postoperatively | Each patient was instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents no pain while 10 represents the worst pain imaginable). NRS was assessed at 0, 3, 6, 12, 18, 24 hours postoperatively. |
| Time to first rescue analgesia | 24 hours postoperatively | Time to the first request for the rescue analgesia (time from the end of surgery to the first dose of pethidine administrated). |
| Total pethidine consumption | 24 hours postoperatively | Rescue analgesia of pethidine 0.5μg/kg was given as a bolus if the numeric rating scale (NRS) \> 3. |
| Incidence of adverse events | 24 hours postoperatively | Incidence of adverse events such as itching, bradycardia, hypotension, pruritis, urinary retention, headache, respiratory depression, miosis, and seizures were recorded. |
Countries
Egypt
Outcome results
None listed