Tropisetron on Postoperative Pain

Study Overview
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Brief Summary
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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.

Official Title
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Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Group P+P
* Drug: Group P+T
* Drug: Group S+P
* Drug: Group S+T


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P+P<br> | Drug: Group P+P<br>* 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.<br>|
| Experimental: P+T<br> | Drug: Group P+T<br>* 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.<br>|
| Placebo Comparator: S+P<br> | Drug: Group S+P<br>* 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.<br>|
| Experimental: S+T<br> | Drug: Group S+T<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 0.5 postoperative hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 2,4,6,8,10,12,14,16,18,20,22,24 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 | At 5, 10,15,20,25,30 min after induction and 30, 25, 20, 15,10,5 min before last suture | 
| Postoperative shivering | The incidence of shiver within 24 h was recorded. | At 24 hour postoperativelly | 
| The incidence of postoperative nausea and vomiting (PONV) | The incidence of postoperative nausea and vomiting (PONV) was recorded at 24 h after surgery. | At 24 hour postoperativelly | 
| Quality of Recovery Score 40 | Quality of Recovery Score 40 was determined at 24 hours postoperativelly | At 24 postoperative hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General anaesthetics, gynaecological laparoscopy, anaesthetic i.v., propofol, anaesthetic volatile, evoflurane, antiemetics, reopisetron, postoperative pain