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

Kafrelsheikh University

Status: Completed

Conditions: Vomiting; Morphine; Mirtazapine; Nausea; Intrathecal; Prophylactic

Treatments: Drug: Mirtazapine + Bupivacaine + Morphine; Drug: Placebo+ Bupivacaine + Morphine; Drug: Placebo + Bupivacaine + Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06681805

36264PR752/7/24

Details and patient eligibility

About

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

Full 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

Enrollment: 120 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

Groups I

Experimental group

Description:

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

Treatment:

Drug: Mirtazapine + Bupivacaine + Morphine

Drug: Mirtazapine + Bupivacaine + Morphine

Groups II

Experimental group

Description:

Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.

Treatment:

Drug: Mirtazapine + Bupivacaine + Morphine

Drug: Mirtazapine + Bupivacaine + Morphine

Groups III

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo + Bupivacaine + Morphine

Groups IV

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo+ Bupivacaine + Morphine