Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
296 participants
INTERVENTIONAL
2010-01-31
2010-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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P+P
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.
P+T
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.
S+P
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.
S+T
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.
Interventions
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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.
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.
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.
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 Criteria
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Inclusion Criteria
* American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
* undergoing selective gynaecological laparoscopies for infertilities
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology
Principal Investigators
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Wei Mei
Role: STUDY_DIRECTOR
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
Yuke Tian, MD.
Role: STUDY_CHAIR
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Other Identifiers
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TJHMZK11001
Identifier Type: -
Identifier Source: org_study_id