search
Back to results

Tropisetron on Postoperative Pain

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Group P+P
Group P+T
Group S+P
Group S+T
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring General anaesthetics, gynaecological laparoscopy, anaesthetic i.v., propofol, anaesthetic volatile, evoflurane, antiemetics, reopisetron, postoperative pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

P+P

P+T

S+P

S+T

Arm Description

Outcomes

Primary Outcome Measures

Postoperative pain at rest
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
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
Heart rate and mean arterial pressure (MAP) every 5 min within 30 min after induction and 30 min before last suture
Postoperative shivering
The incidence of shiver within 24 h was recorded.
The incidence of postoperative nausea and vomiting (PONV)
The incidence of postoperative nausea and vomiting (PONV) was recorded at 24 h after surgery.
Quality of Recovery Score 40
Quality of Recovery Score 40 was determined at 24 hours postoperativelly

Full Information

First Posted
February 25, 2011
Last Updated
February 25, 2011
Sponsor
Huazhong University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT01304953
Brief Title
Tropisetron on Postoperative Pain
Official Title
Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
General anaesthetics, gynaecological laparoscopy, anaesthetic i.v., propofol, anaesthetic volatile, evoflurane, antiemetics, reopisetron, postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P+P
Arm Type
Placebo Comparator
Arm Title
P+T
Arm Type
Experimental
Arm Title
S+P
Arm Type
Placebo Comparator
Arm Title
S+T
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Group P+P
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Group P+T
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Group S+P
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Group S+T
Intervention Description
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 Outcome Measure Information:
Title
Postoperative pain at rest
Description
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.
Time Frame
At 0.5 postoperative hour
Secondary Outcome Measure Information:
Title
Postoperative pain at rest
Description
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.
Time Frame
At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours
Title
Intraoperative hemodynamic values
Description
Heart rate and mean arterial pressure (MAP) every 5 min within 30 min after induction and 30 min before last suture
Time Frame
At 5, 10,15,20,25,30 min after induction and 30, 25, 20, 15,10,5 min before last suture
Title
Postoperative shivering
Description
The incidence of shiver within 24 h was recorded.
Time Frame
At 24 hour postoperativelly
Title
The incidence of postoperative nausea and vomiting (PONV)
Description
The incidence of postoperative nausea and vomiting (PONV) was recorded at 24 h after surgery.
Time Frame
At 24 hour postoperativelly
Title
Quality of Recovery Score 40
Description
Quality of Recovery Score 40 was determined at 24 hours postoperativelly
Time Frame
At 24 postoperative hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Mei
Organizational Affiliation
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuke Tian, MD.
Organizational Affiliation
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Learn more about this trial

Tropisetron on Postoperative Pain

We'll reach out to this number within 24 hrs