Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section

Not Applicable

Completed

• Conditions: Prophylactic; Mirtazapine; Intrathecal; Morphine; Nausea; Vomiting
• Interventions: Drug: Mirtazapine + Bupivacaine + Morphine; Drug: Placebo + Bupivacaine + Morphine; Drug: Placebo+ Bupivacaine + Morphine

• Registration Number: NCT06681805
• Lead Sponsor: Kafrelsheikh University

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

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-09-25
• Study Completion: 2024-09-25
• Status Verified: 2024-11
• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Groups I	Mirtazapine + 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.
Groups II	Mirtazapine + Bupivacaine + Morphine	Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.
Groups III	Placebo + Bupivacaine + Morphine	Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.2 mg of morphine.
Groups IV	Placebo+ Bupivacaine + Morphine	Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt