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The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

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Seoul National University

Status

Unknown

Conditions

Vomiting
Nausea
Laparoscopic Cholecystectomy

Treatments

Drug: intravenous ramosetron
Drug: oral ramosetron
Drug: oral and IV ramosetron

Study type

Interventional

Funder types

Other

Identifiers

NCT01041183
nasea-LC

Details and patient eligibility

About

Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.

Enrollment

120 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA I-II patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia

Exclusion criteria

  • GI disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 3 patient groups

group I
Active Comparator group
Description:
0.3 mg IV ramosetron
Treatment:
Drug: intravenous ramosetron
group II
Active Comparator group
Description:
0.1 mg oral ramosetron
Treatment:
Drug: oral ramosetron
group III
Active Comparator group
Description:
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron
Treatment:
Drug: oral and IV ramosetron

Trial contacts and locations

1

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Central trial contact

Jung-Hee Ryu, Ph.D

Data sourced from clinicaltrials.gov

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