Tropisetron on Postoperative Pain

NCT01304953 | Completed Phase 4 DMC

• 1 other identifier: TJHMZK11001
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

General anaesthetics; gynaecological laparoscopy; anaesthetic i.v.; propofol; anaesthetic volatile; evoflurane; antiemetics; reopisetron; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative pain at rest

  At 2,4,6,8,10,12,14,16,18,20,22,24 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

• Postoperative shivering

  At 24 hour postoperativelly

• The incidence of postoperative nausea and vomiting (PONV)

  At 24 hour postoperativelly

• Quality of Recovery Score 40

  At 24 postoperative hour

Study Arms (4)

P+P

PLACEBO COMPARATOR

Drug: Group P+P

P+T

EXPERIMENTAL

Drug: Group P+T

S+P

PLACEBO COMPARATOR

Drug: Group S+P

S+T

EXPERIMENTAL

Drug: Group S+T

Interventions

Group P+P DRUG

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+P

Group P+T DRUG

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.

P+T

Group S+P DRUG

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+P

Group S+T DRUG

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.

S+T

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients
• American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
• undergoing selective gynaecological laparoscopies for infertilities

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Wei Mei

  Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China

  STUDY DIRECTOR

• Yuke Tian, MD.

  Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 28, 2011

Record last verified: 2011-02

Locations

CN (1)