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

Not Applicable

Not yet recruiting

• Conditions: Morphine Adverse Reaction
• Interventions: Drug: Atropine and Dexamethasone

• Registration Number: NCT05560542
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-17
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-29
• Last Update Submitted: 2022-09-30
• Study Start: 2022-10-01
• Last Update Posted: 2022-10-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Female
2. 18-45 years old
3. ASA: 1, 2
4. Elective caesarean section under spinal anaesthesia.

Exclusion Criteria

1. Patient refusal.
2. Contraindications to spinal anaesthesia as coagulopathy, infection at site of injection, hemodynamic instability and uncooperative patient.
3. Contraindications to administration of morphine as asthmatic patient and hypersensitivity and contraindications to any of the study drugs.
4. Adult-Emergency CS as there is no time for preparation and risk on fetus and mother for time consuming

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone and Atropine group (DA)	Atropine and Dexamethasone	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) \[Total volume 4.5 ml\] .
Dexamethasone group (D)	Atropine and Dexamethasone	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).
Atropine group (A)	Atropine and Dexamethasone	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) \[Total volume 3.5 ml\].

Primary Outcome Measures

Name	Time	Method
Incidence and severity of PONV	24 hour	Incidence and severity of PONV by designing questionnaire and specific scale: 1. no nausea or vomiting; 2. mild nausea and vomiting but no need to treatment; 3. moderate nausea and vomiting that need treatment; 4. severe form of nausea and vomiting and resistant to treatment

Secondary Outcome Measures

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