Tropisetron on Postoperative Pain

This study has been completed.
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01304953
First received: February 25, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: Group P+P
Drug: Group P+T
Drug: Group S+P
Drug: Group S+T
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Postoperative pain at rest [ Time Frame: At 0.5 postoperative hour ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Postoperative pain at rest [ Time Frame: At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    Heart rate and mean arterial pressure (MAP) every 5 min within 30 min after induction and 30 min before last suture

  • Postoperative shivering [ Time Frame: At 24 hour postoperativelly ] [ Designated as safety issue: Yes ]
    The incidence of shiver within 24 h was recorded.

  • The incidence of postoperative nausea and vomiting (PONV) [ Time Frame: At 24 hour postoperativelly ] [ Designated as safety issue: Yes ]
    The incidence of postoperative nausea and vomiting (PONV) was recorded at 24 h after surgery.

  • Quality of Recovery Score 40 [ Time Frame: At 24 postoperative hour ] [ Designated as safety issue: Yes ]
    Quality of Recovery Score 40 was determined at 24 hours postoperativelly


Enrollment: 296
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P+P Drug: Group P+P

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.

Experimental: P+T Drug: Group P+T

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.

Placebo Comparator: S+P Drug: Group S+P

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.

Experimental: S+T Drug: Group S+T

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.


  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304953

Locations
China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Study Director: Wei Mei Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
Study Chair: Yuke Tian, MD. Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
  More Information

No publications provided

Responsible Party: Prof. Yuke Tian, Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology
ClinicalTrials.gov Identifier: NCT01304953     History of Changes
Other Study ID Numbers: TJHMZK11001
Study First Received: February 25, 2011
Last Updated: February 25, 2011
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
General anaesthetics
gynaecological laparoscopy
anaesthetic i.v.
propofol
anaesthetic volatile
evoflurane
antiemetics
reopisetron
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Tropisetron
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014