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RANDOMIZED, DOUBLE-BLIND STUDY, CONTROLLED WITH ACTIVE COMPARATOR, OF PARALLEL GROUPS, CARRIED OUT UNDER INTERNAL BLIND CONDITIONS TO EXAMINE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF 2 DOSE OF APPRENTICATOR IN THE PREVENTION OF NAUSEA AND POST-OPERATIVE VOMITING

RANDOMIZED, DOUBLE-BLIND STUDY, CONTROLLED WITH ACTIVE COMPARATOR, OF PARALLEL GROUPS, CARRIED OUT UNDER INTERNAL BLIND CONDITIONS TO EXAMINE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF 2 DOSE OF APPRENTICATOR IN THE PREVENTION OF NAUSEA AND POST-OPERATIVE VOMITING

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-020-04
Enrollment
116
Registered
2004-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

40 mg aprepitant Type of group
A single dose of 40 mg aprepitant capsules is administered at least 1 hour and no more than 3 hours before the induction of the expected anesthesia. Group name:ondansetron 4 mg Type of group
Ondansetron 4 mg administered IV will be applied immediately before the induction of anesthesia. Also, the placebo will be administered for aprepitant or ondansetron in order to keep the blind.

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. The patient is at least 18 years of age. b. The patient is able to understand the study procedures and agrees to participate in it by providing written informed consent. c. The patient is scheduled to undergo open abdominal surgery that requires staying in the hospital until the next day (staying 24 hours in the hospital after the end of surgery). d. The patient is scheduled to receive general anesthesia.

Exclusion criteria

Exclusion criteria: a. The patient is scheduled to receive propofol for maintenance of anesthesia b. Placement of a nasogastric or oral gastric tube intra or postoperatively. c. The patient is allergic to pre-operative tranquillizers, operative anesthetics, postoperative analgesia, aprepitant, ondansetron or any other programmed 5-HT3 antagonist. d. It is anticipated that the patient will receive neuraxial anesthesia, such as epidural, spinal or caudal anesthesia.

Design outcomes

Primary

MeasureTime frame
Outcome name:nauseas y vomitos postoperatorios Measure:aprepitant (125 mg, 40 mg) is superior to ondansetron in the prevention of postoperative nausea and vomiting Timepoints:24 hours—

Secondary

MeasureTime frame
Outcome name:postoperative nausea and vomiting Measure:Aprepitant (125 mg, 40 mg) is superior to ondansetron in the prevention of postoperative nausea and vomiting from the point of view of the time to the first episode of vomiting in the time frame from 0 to 48 hours. Timepoints:48 hours—

Countries

Peru, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)