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NCT Number: NCT06681805

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

The aim of this work was to evaluate the role of prophylactic mirtazapine and different doses of intrathecal morphine in preventing nausea and vomiting.

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Key information

Conditions

Prophylactic Intrathecal Mirtazapine Morphine Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mirtazapine + Bupivacaine + Morphine

Drug

Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5% along with 0.2 mg of morphine.

Placebo + Bupivacaine + Morphine

Drug

Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.2 mg of morphine.

Placebo+ Bupivacaine + Morphine

Drug

Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.

Primary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: 24 hours postoperatively

    Incidence of postoperative nausea and vomiting was recorded at 3, 6, 12, 18, 24 hours postoperatively.

Secondary outcomes

  1. Degree of pain

    Time frame: 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.

  2. Time to first rescue analgesia

    Time frame: 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).

  3. Total pethidine consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia of pethidine 0.5μg/kg was given as a bolus if the numeric rating scale (NRS) > 3.

  4. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as itching, bradycardia, hypotension, pruritis, urinary retention, headache, respiratory depression, miosis, and seizures were recorded.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Role of Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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