Tropisetron on Postoperative Pain

Pain, Postoperative Clinical Trial

Official title:

Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304953
• Other study ID #: TJHMZK11001
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2011
• Last updated: February 25, 2011
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Postoperative shivering	The incidence of shiver within 24 h was recorded.	At 24 hour postoperativelly	Yes
Secondary	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	Yes
Secondary	Quality of Recovery Score 40	Quality of Recovery Score 40 was determined at 24 hours postoperativelly	At 24 postoperative hour	Yes