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NCT Number: NCT05560542

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university, faculty of medicine

Asyut, Asyut Governorate, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine and Dexamethasone

Drug

Intrathecal dexamethasone, atropine or their combination.

Primary outcomes

  1. Incidence and severity of PONV

    Time frame: 24 hour

    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

Secondary outcomes

  1. Antiemetic

    Time frame: 24 hour

    Total dose of post-operative rescue antiemetic (ondansetron in mg) for 24 hour

  2. Post-operative pain profile

    Time frame: 24 hour

    Post-operative visual analog scale (1: no pain and 10: the most severe experienced pain ) for 24 hour.

  3. Incidence of Side Effects

    Time frame: 24 hour

    Anticipated side effects as shivering and hypotension( number of patients and severity)

  4. Analgesia

    Time frame: 24 hour

    Time to the first post-operative rescue analgesic for 24 hour.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2022
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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