Intrathecal Dexamethasone and Atropine on Morphine Induced Post-operative Nausea and Vomiting on Caesarean Section

Study Overview
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Brief Summary
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Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain. Morphine has many complications like post-operative nausea and vomiting (PONV). the investigators will investigate the utility of intrathecal (IT) atropine and dexamethasone for prevention of morphine induced PONV as a primary outcome in parturient undergoing CS under spinal bupivacaine anesthesia plus morphine sulfate as an adjuvant.

Detailed Description
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Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain in many surgical areas including Caesarean delivery. Morphine has many complications namely pruritus, and post-operative nausea and vomiting (PONV). The other risk factors for the development of PONV include female gender, non-smoker status, general anesthesia with inhalational anesthetics and surgical factors (duration and type of surgery). The supplementation of morphine, however raises the occurrences of postoperative nausea and vomiting (PONV) in these patient To tackle this problem, the investigators have to use the combination therapy of antiemetics like a serotonin receptor antagonist of either intravenous (IV) ondansetron or granisetron with IV dexamethasone is administered after the administration of intrathecal morphine. Dopamine receptor antagonists e.g. droperidol and metoclopramide are commonly used, but they carry the risk of extrapyramidal symptoms.

Official Title
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Prophylactic Efficacy and Safety of Intrathecal Dexamethasone, Atropine or Their Combination on Morphine Induced Post-operative Nausea and Vomiting on Patients Undergoing Caesarean Section With Spinal Anaesthesia

Conditions
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Morphine Adverse Reaction

Intervention / Treatment
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* Drug: Atropine and Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18-45 years old ASA: 1, 2 Elective caesarean section under spinal anaesthesia. Exclusion Criteria: Patient refusal. Contraindications to spinal anaesthesia as coagulopathy, infection at site of injection, hemodynamic instability and uncooperative patient. Contraindications to administration of morphine as asthmatic patient and hypersensitivity and contraindications to any of the study drugs. Adult-Emergency CS as there is no time for preparation and risk on fetus and mother for time consuming

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dexamethasone group (D)<br>Patients will receive intrathecal hyperbaric bupivacaine 0.5% in a dose of 12.5 mg (2.5 ml) mixed with morphine in a dose of 200 µg (0.5 ml was withdrawn from a syringe containing 4 mg morphine sulfate diluted in 10 ml normal saline) [Total volume 4 ml], followed by intrathecal dexamethasone 4 mg (1ml). | Drug: Atropine and Dexamethasone<br>* Intrathecal dexamethasone, atropine or their combination.<br>|
| Other: Atropine group (A)<br>Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg (2.5 ml 0.5%) mixed with morphine 200 µg (0.5 ml) and atropine100 µg (0.5 ml was withdrawn from a syringe containing 2 mg atropine sulfate diluted in 10 ml normal saline) [Total volume 3.5 ml]. | Drug: Atropine and Dexamethasone<br>* Intrathecal dexamethasone, atropine or their combination.<br>|
| Other: Dexamethasone and Atropine group (DA)<br>Patients will receive intrathecal hyperbaric bupivacaine in a dose of 12.5 mg (2.5 ml) mixed with morphine 200 µg (0.5 ml) and atropine 100 µg (0.5 ml), followed by intrathecal injection of dexamethasone 4 mg (1 ml) [Total volume 4.5 ml] . | Drug: Atropine and Dexamethasone<br>* Intrathecal dexamethasone, atropine or their combination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of PONV | Incidence and severity of PONV by designing questionnaire and specific scale: no nausea or vomiting mild nausea and vomiting but no need to treatment moderate nausea and vomiting that need treatment severe form of nausea and vomiting and resistant to treatment | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiemetic | Total dose of post-operative rescue antiemetic (ondansetron in mg) for 24 hour | 24 hour | 
| Post-operative pain profile | Post-operative visual analog scale (1: no pain and 10: the most severe experienced pain ) for 24 hour. | 24 hour | 
| Incidence of Side Effects | Anticipated side effects as shivering and hypotension( number of patients and severity) | 24 hour | 
| Analgesia | Time to the first post-operative rescue analgesic for 24 hour. | 24 hour |