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Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy

ConditionPostoperative Nausea and Vomiting (PONV)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorAssiut University

About this trial

Postoperative nausea and vomiting (PONV) remain common and distressing complications following laparoscopic cholecystectomy, particularly in female patients. This randomized interventional study aims to evaluate the effectiveness of preoperative granisetron when combined with either dexamethasone or metoclopramide in preventing PONV. The study compares the incidence and severity of nausea and vomiting, as well as the need for rescue antiemetic therapy, among female patients undergoing laparoscopic cholecystectomy under general anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

1- History of hypersensitivity to study drugs. 2- Chronic antiemetic. 3- Antidepressant use. 4- Gastrointestinal disease. 5- Pregnancy/lactation. 6- Severe hepatic/renal dysfunction

Trial design

Design model

Parallel

Treatments tested in this trial

  • Granisetron

    Drug

    Granisetron will be administered intravenously preoperatively for prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Granisetron + DexamethasoneExperimental treatment 1 intervention
Group B: Granisetron + MetoclopramideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative nausea and vomiting (PONV)

The incidence of postoperative nausea and vomiting (PONV) will be recorded and compared between the two study groups.

Time frame
0-24 hours postoperatively

Secondary outcomes

1

Severity of postoperative nausea

Severity of nausea will be assessed using a visual analog scale (VAS) ranging from 0 to 10.

Time frame
0-24 hours postoperatively
2

Number of vomiting or retching episodes

The total number of vomiting or retching episodes will be recorded for each patient.

Time frame
0-24 hours postoperatively
3

Requirement for rescue antiemetic medication

The need for rescue antiemetic medication will be recorded during the postoperative period.

Time frame
0-24 hours postoperatively
4

Patient satisfaction score

Patient satisfaction with postoperative nausea and vomiting management will be assessed using a satisfaction scoring system.

Time frame
0-24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: