Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Yeungnam University College of Medicine

Status: Completed

Conditions: Postoperative Vomiting; Postoperative Nausea

Treatments: Drug: midazolam and palonosetron group; Drug: palonosetron group

Study type: Interventional

Funder types: Other

Identifiers

NCT03933605

YUMC 2017-04-030

Details and patient eligibility

About

In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.

Enrollment: 88 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2

Exclusion criteria

• The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index > 30 kg/m2

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

midazolam and palonosetron

Active Comparator group

Description:

0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction

Treatment:

Drug: midazolam and palonosetron group

palonosetron

Active Comparator group

Description:

the same volume (0.05 mg/kg) of normal saline i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction

Treatment:

Drug: palonosetron group