Tropisetron on Postoperative Pain

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Group P+P; Drug: Group P+T; Drug: Group S+P; Drug: Group S+T

• Registration Number: NCT01304953
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2011-02
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Last Update Submitted: 2011-02-25
• Study First Posted: 2011-02-28
• Last Update Posted: 2011-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 296

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P+P	Group P+P	-
P+T	Group P+T	-
S+P	Group S+P	-
S+T	Group S+T	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain at rest	At 0.5 postoperative hour	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

Name	Time	Method
Postoperative pain at rest	At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours	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	At 5, 10,15,20,25,30 min after induction and 30, 25, 20, 15,10,5 min before last suture	Heart rate and mean arterial pressure (MAP) every 5 min within 30 min after induction and 30 min before last suture
Postoperative shivering	At 24 hour postoperativelly	The incidence of shiver within 24 h was recorded.
The incidence of postoperative nausea and vomiting (PONV)	At 24 hour postoperativelly	The incidence of postoperative nausea and vomiting (PONV) was recorded at 24 h after surgery.
Quality of Recovery Score 40	At 24 postoperative hour	Quality of Recovery Score 40 was determined at 24 hours postoperativelly

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China