Tropisetron on Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several
      animal models. However, studies in human volunteers have not been reported except for one
      recent study suggesting that ondansetron could alleviate propofol-induced nociception.
      Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain
      than those anaesthetized with propofol. And we further posit that the difference is due to
      the nociceptive processing induced by the action of 5-HT3A receptors.

      In this prospective, randomized, double-blind, placebo-controlled study, we assessed the
      analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological
      laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.
    


Intervention name(s): Group P+P; Group P+T; Group S+P; Group S+T
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In this arm, anaesthesia was maintained with propofol and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely propofol was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
Patients in this arms received saline placebo i.v. after the induction of anaesthesia.; In this arm, anaesthesia was maintained with propofol and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely propofol was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
Patients in this arms received tropisetron 2 mg i.v. after the induction of anaesthesia.; In this arm, anesthesia was maintained by sevoflurane and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely sevoflurane was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
Patients in this arms received saline placebo i.v. after the induction of anaesthesia.; In this arm, anesthesia was maintained by sevoflurane and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely sevoflurane was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
Patients in this arms received tropisetron 2 mg i.v. after the induction of anaesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: General anaesthetics; gynaecological laparoscopy; anaesthetic i.v.; propofol; anaesthetic volatile; evoflurane; antiemetics; reopisetron; postoperative pain