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Spinal Morphine and Atropine Added to General Anaesthesia for Nausea and Pain After Abdominal Laparoscopy

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Laparoscopic abdominal surgery carries one of the highest risks of postoperative nausea and vomiting (PONV), and postoperative opioids given for pain are themselves emetogenic. Intrathecal morphine provides prolonged analgesia but increases nausea; intrathecal atropine 100 µg has been reported to reduce morphine-related nausea under spinal anaesthesia alone, but has not been tested within a combined spinal-general technique. This randomised, open-label, parallel-group trial compared combined spinal-general anaesthesia (CSGA), hyperbaric bupivacaine 10 mg, morphine 100 µg and atropine 100 µg given intrathecally before induction, followed by general anaesthesia, with general anaesthesia (GA) alone in adults undergoing elective abdominal laparoscopy. Both groups received identical general anaesthesia, multimodal analgesia (paracetamol and ketorolac at skin closure), end-of-case ondansetron and neostigmine-atropine reversal. The primary outcome was the occurrence of PONV within 24 hours after surgery. Secondary outcomes were postoperative pain, rescue antiemetic and rescue opioid requirements, intraoperative fentanyl consumption and perioperative haemodynamics.
Trial Details
NCT Number NCT07851870
Lead Sponsor Universitas Indonesia
Collaborators: Fakultas Kedokteran Universitas Indonesia
Conditions
(from sponsor)
Postoperative Nausea and Vomiting, Postoperative Pain, Anesthesia, Anesthesia Spinal, Laparoscopy
Related terms Postoperative Nausea and Vomiting, Postoperative Pain
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov