NCT05134363

Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Dexmedetomidine for Prophylaxis Against Postoperative Nausea and Vomiting in Highly Susceptible Patients: a Randomised Controlled Comparison of Two Bolus Doses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.

Detailed description

Being A challenging complaint, many studies tried to find an effective preventive strategies for PONV. In this study protocol the investigators aim to compare between 0.5 mic/kg and 0.75 mic/kg bolus doses of dexmedetomidine when given toward the end of head and neck surgeries in highly susceptible patients with a controlled group receiving ondansetron. The primary outcome is the 1st 24 hours incidence of PONV Other outcomes include: * Time to 1st call for rescue antiemetic and the total amount of antiemetics * Number of PONV attacks * Post operative pain score with visual analogous scale (VAS) and time to 1st call for rescue analgesia * Sedation Score using Observer's Assessment of Alertness and sedation (OAA/S) * Patient satisfaction * Vital signs in the 1st 24 hours

Conditions

• Postoperative Nausea and Vomiting
• Head and Neck Surgeries

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Hydrochloride 0.5 mic/kg bolus	comparison between two bolus doses of dexmedetomidine with a placebo group
DRUG	Dexmedetomidine Hydrochloride 0.75 mic/kg bolus	comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.
DRUG	Placebo	equal volume of normal saline

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2021-11-24
• Last updated: 2023-08-30

Locations

1 site across 1 country: Egypt