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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-09-25

Brief Summary

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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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Detailed Description

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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

Conditions

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Prophylactic Mirtazapine Intrathecal Morphine Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mirtazapine + Bupivacaine + Morphine

Intervention Type 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 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.

Group Type EXPERIMENTAL

Mirtazapine + Bupivacaine + Morphine

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo + Bupivacaine + Morphine

Intervention Type DRUG

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

Groups IV

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

Group Type PLACEBO_COMPARATOR

Placebo+ Bupivacaine + Morphine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No