Tropisetron on Postoperative Pain

Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Group P+P; Drug: Group P+T; Drug: Group S+P; Drug: Group S+T

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): February 28, 2011
• Last Update Submitted That Met QC Criteria: February 25, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: propofol; postoperative pain; antiemetics; General anaesthetics; gynaecological laparoscopy; anaesthetic i.v.; anaesthetic volatile; evoflurane; reopisetron
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: TJHMZK11001