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COMPLETED
NCT07851870
PHASE4

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

Sponsor: Universitas Indonesia

View on ClinicalTrials.gov

Summary

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.

Official title: Title Combined Spinal-General Anaesthesia With Low-Dose Intrathecal Morphine and Atropine for Abdominal Laparoscopy: A Randomised Controlled Trial of Postoperative Nausea, Vomiting and Pain

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2026-02-02

Completion Date

2026-03-26

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

Intrathecal bupivacaine, morphine and atropine

Hyperbaric bupivacaine 10 mg + preservative-free morphine 100 µg + atropine sulphate 100 µg in 4 mL, single intrathecal injection before induction

PROCEDURE

General anaesthesia

Lidocaine, fentanyl, propofol, rocuronium induction; sevoflurane maintenance; neostigmine-atropine reversal

DRUG

Multimodal analgesia and antiemetic prophylaxis

Paracetamol 1 g and ketorolac 30 mg IV at skin closure; ondansetron 4 mg IV at end of anaesthesia

Locations (1)

Cipto Mangunkusumo National Central General Hospital (RSCM)

Jakarta Pusat, DKI Jakarta, Indonesia