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

NCT06681805 | Completed

• 1 other identifier: 36264PR752/7/24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Prophylactic; Mirtazapine; Intrathecal; Morphine; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Degree of pain

  24 hours postoperatively

• Time to first rescue analgesia

  24 hours postoperatively

• Total pethidine consumption

  24 hours postoperatively

• Incidence of adverse events

  24 hours postoperatively

Study Arms (4)

Groups I

EXPERIMENTAL

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

Groups II

EXPERIMENTAL

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

Groups III

PLACEBO COMPARATOR

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

Groups IV

PLACEBO COMPARATOR

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

Interventions

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.

Groups I

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.

Groups IV

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women scheduled for a cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Scheduled for caesarean section under spinal anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Mirtazapine; Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: January 1, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)