Comparing the effect of a combination of Promethazine, Dexamethasone, Ondansetron in comparison with Haloperidol, Dexamethasone, Ondansetron for prophylaxis of nausea and vomiting after bariatric surgery

Determining the effect of a combination of Promethazine, Dexamethasone, and Ondansetron in comparison with Haloperidol, Dexamethasone, Ondansetron for prophylaxis of nausea and vomiting after laparoscopic bariatric surgery in Sina hospital, 2018.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170805035510N3

Enrollment

Registered

2018-06-22

Start date

2018-03-06

Completion date

Unknown

Last updated

2018-07-16

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

Conditions

post operative nausea and vomiting after Bariatric surgery. Obesity due to excess calories

Interventions

Intervention 1: Group A receives a three-drug regimen (Ondansetron 4 mg, Dexamethasone 8 mg, and Haloperidol 2 mg) Patients receive Dexamethasone 8 mg after induction and at the beginning of surgery a

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: • Age 18-65 years • BMI>30 • ASA class I or II • At least 2 risk factors for postoperative nausea and vomiting according to the Apfel criteria

Exclusion criteria

Exclusion criteria: • Contraindication to Dexamethasone, Ondansetron, Haloperidol, and Promethazine • Use of illegal drugs, hormonal anti-inflammatory drugs, and antiemetics within 24 hours before surgery • Serious adverse reaction like shock, cardiac arrest, and hemorrhage requiring transfusion • Pregnancy and lactation • Psychiatric diseases treated with antipsychotics • History of migraines • Cardiac pacemaker • History of prolonged QT

Design outcomes

Primary

Measure	Time frame
Post operative nausea and vomiting score. Timepoint: Recovery room,6hours after surgery,24hours after surgery. Method of measurement: NVRS(Nausea Verbal Rating Scale).;First time of antiemetic prescription after surgery. Timepoint: Until 24hours after surgery. Method of measurement: according to physician's orders and nursing notes.;Accumulative dose of antiemetics prescription after surgery. Timepoint: 24hours after surgery ended. Method of measurement: according to recorded physician's orders and nursing notes.;Recovery time. Timepoint: Until discharge of recovery room. Method of measurement: According to medical records.	—

Measure

Time frame

Post operative nausea and vomiting score. Timepoint: Recovery room,6hours after surgery,24hours after surgery. Method of measurement: NVRS(Nausea Verbal Rating Scale).;First time of antiemetic prescription after surgery. Timepoint: Until 24hours after surgery. Method of measurement: according to physician's orders and nursing notes.;Accumulative dose of antiemetics prescription after surgery. Timepoint: 24hours after surgery ended. Method of measurement: according to recorded physician's orders and nursing notes.;Recovery time. Timepoint: Until discharge of recovery room. Method of measurement: According to medical records.

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Secondary

Measure	Time frame
Post operative adverse effects. Timepoint: Until 24 hours after surgery. Method of measurement: Occurrence of Life threatening complications or annoying complaints for patients.;Accumulative dose of prescribed narcotics. Timepoint: 6 hours and 24 hours after surgery. Method of measurement: according to physician's orders and nursing note.;Post operative pain score. Timepoint: recovery room,6hours after surgery,24hours after surgery. Method of measurement: patients rate pain severity according to tutored scale (0-10).	—

Measure

Time frame

Post operative adverse effects. Timepoint: Until 24 hours after surgery. Method of measurement: Occurrence of Life threatening complications or annoying complaints for patients.;Accumulative dose of prescribed narcotics. Timepoint: 6 hours and 24 hours after surgery. Method of measurement: according to physician's orders and nursing note.;Post operative pain score. Timepoint: recovery room,6hours after surgery,24hours after surgery. Method of measurement: patients rate pain severity according to tutored scale (0-10).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNiusha Momeni

Tehran University of Medical Sciences

n.barid@yahoo.com+98 21 5593 8580

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026