Skip to main content
OpenTrials
Completed

NCT Number: NCT01304953

Tropisetron on Postoperative Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • female patients
  • American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
  • undergoing selective gynaecological laparoscopies for infertilities

Exclusion criteria

  • aged under 18 years old
  • body mass index (BMI) > 30
  • history of cardiovascular disease
  • history of respiratory disease
  • history of neurologic disease
  • history of chronic antidepressants
  • history of anxiolytics
  • history of chronic analgesics intake
  • participating in other studies

Treatment and study plan

Group P+P

Drug

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.

Group P+T

Drug

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.

Group S+P

Drug

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.

Group S+T

Drug

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.

Primary outcomes

  1. Postoperative pain at rest

    Time frame: At 0.5 postoperative hour

    The primary outcome was the postoperative pain at rest assessed by numeric analog score (NAS, where 0 indicates no pain, and 10 indicates the most severe pain) immediately after awaking.

Secondary outcomes

  1. Postoperative pain at rest

    Time frame: At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours

    The patients were instructed to give the number that represented the pain level at rest soon after awakening, the first 30 min postoperatively, and every 2 hours within the first 24 postoperative hours.

  2. Intraoperative hemodynamic values

    Time frame: At 5, 10,15,20,25,30 min after induction and 30, 25, 20, 15,10,5 min before last suture

    Heart rate and mean arterial pressure (MAP) every 5 min within 30 min after induction and 30 min before last suture

  3. Postoperative shivering

    Time frame: At 24 hour postoperativelly

    The incidence of shiver within 24 h was recorded.

  4. The incidence of postoperative nausea and vomiting (PONV)

    Time frame: At 24 hour postoperativelly

    The incidence of postoperative nausea and vomiting (PONV) was recorded at 24 h after surgery.

  5. Quality of Recovery Score 40

    Time frame: At 24 postoperative hour

    Quality of Recovery Score 40 was determined at 24 hours postoperativelly

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 28, 2011
Registry last updated
Feb 28, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.