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

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

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

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting; Morphine; Prophylactic; Intrathecal; Mirtazapine
• Intervention / Treatment: Drug: Mirtazapine + Bupivacaine + Morphine; Drug: Mirtazapine + Bupivacaine + Morphine; Drug: Placebo + Bupivacaine + Morphine; Drug: Placebo+ Bupivacaine + Morphine

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Groups I; Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5% along with 0.2 mg of morphine.	Drug: 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.; Drug: 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.
Experimental: Groups II; Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.	Drug: 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.; Drug: 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.
Placebo Comparator: Groups III; Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.2 mg of morphine.	Drug: 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.
Placebo Comparator: Groups IV; Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting was recorded at 3, 6, 12, 18, 24 hours postoperatively.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	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.	24 hours postoperatively
Time to first rescue analgesia	Time to the first request for the rescue analgesia (time from the end of surgery to the first dose of pethidine administrated).	24 hours postoperatively
Total pethidine consumption	Rescue analgesia of pethidine 0.5μg/kg was given as a bolus if the numeric rating scale (NRS) > 3.	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as itching, bradycardia, hypotension, pruritis, urinary retention, headache, respiratory depression, miosis, and seizures were recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 25, 2024
• Study Completion (Actual): September 25, 2024

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Adrenergic Agents; Antidepressive Agents; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Adrenergic Antagonists; Serotonin 5-HT2 Receptor Antagonists; Adrenergic alpha-Antagonists; Histamine H1 Antagonists; Adrenergic alpha-2 Receptor Antagonists; Mirtazapine; Bupivacaine; Morphine
• Other Study ID Numbers: 36264PR752/7/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No