Tropisetron on Postoperative Pain

Huazhong University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Group P+P; Drug: Group S+P; Drug: Group S+T; Drug: Group P+T

Study type: Interventional

Funder types: Other

Identifiers

NCT01304953

TJHMZK11001

Details and patient eligibility

About

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.

Enrollment: 296 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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296 participants in 4 patient groups, including a placebo group

P+P

Placebo Comparator group

Treatment:

Drug: Group P+P

P+T

Experimental group

Treatment:

Drug: Group P+T

S+P

Placebo Comparator group

Treatment:

Drug: Group S+P

S+T

Experimental group

Treatment:

Drug: Group S+T