Mustafa Kemal University Medicine Faculty
Hatay, 31030, Turkey (Türkiye)
NCT Number: NCT02296333
The purpose of the study is to determine whether the effect of ondansetron on the analgesic effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of acetaminophen and also reduce opioid consumption
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Notify Me18 year–80 year
Female
Interventional
Phase 4
Hatay, 31030, Turkey (Türkiye)
The investigators enrolled 80 American Society of Anesthesiologists Physical Status I-II women 18-80 years old scheduled for hysterectomy under general anesthesia over the course of a year. The study will be restricted hysterectomies with horizontal abdominal skin incision who will be able to operate a patient-controlled analgesia (PCA) device.
Participating women will be premedicated with 1-2 mg intravenous (IV) midazolam per preference of the attending anesthesiologist.
Anesthesia will be induced with propofol (2 mg/kg IV); intubation will be facilitated by rocuronium (0.6 mg/kg IV); and anesthesia will be maintained by sevoflurane in combination with nitrous oxide 50% in oxygen. Fentanyl, 2 µg/kg intravenous will be given 3-5 min before the surgical incision.
After endotracheal intubation, all patients' lungs will be mechanically ventilated to maintain the end-expiratory carbon dioxide values between 34 and 36 mmHg.
A Pfannenstiel approach will be used in each woman, and the same surgeon will be conducted all operations.
Randomization will be web-based and out of the control of any investigator. The web system will be accessed by the anesthesia resident at the induction. Drugs will be covered by opaque plastic to keep the surgical team and anesthesiologists blinded to treatment.
Both groups patients will be received 1 g acetaminophen in 100 ml saline given every 6 hours starting with the skin closure for 24 hours, an amount generally regarded as safe.
After return of spontaneous ventilation and tracheal extubation, patients will be transferred to the post anesthesia care unit (PACU).
Patients were connected to a patient-controlled analgesia (PCA) device and postoperative analgesia will be provided using 20-mg intravenous bolus injections of tramadol at a lockout interval of 15 min and with a maximum 4-h limit of 150 mg. The PCA device will be discontinued when the patient made no demands for the opioid analgesic in the preceding 4-h interval or at a maximum of 24 hours after surgery.
When pain scores were VAS ≥5, then as a rescue analgesics 75 mg diclofenac Na intramuscularly will be given. If systolic arterial pressure (SAP) will be <90 mmHg or mean arterial pressure will be <50 mmHg, 5 mg intravenous ephedrine HCl will be given. If the heart rate will be <50 beats/minute, 0.5 mg atropine sulfate intravenous will be given. When patients sustained nausea or vomiting lasting longer than 5 minutes, metoclopramide (10 mg intravenously) will be given.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8 mg intravenous in the skin closure
Other names: Zofran
8 mg intravenous in the skin closure
Time frame: Postoperative 24 hours
Visual analogue scale
Time frame: Postoperative 24 hours
Tramadol consumption
Time frame: Postoperative 24 hours
Mustafa Kemal University
Other
Double Blinded Study Ondansetron's Opposite Effect on Postoperative Analgesia of Acetaminophen
Acronym: OOEOPAOA
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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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