Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Cairo University (CU)

Status: Completed

Conditions: Postoperative Nausea and Vomiting; Head and Neck Surgeries

Treatments: Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus; Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05134363

MD-208-2021

Details and patient eligibility

About

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

Full 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

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Two risk factors or more for PONV ( female, non-smoking, postoperative opioids, history of motion sickness or PONV )
• Head and neck surgeries in adults
• ASA ( I , II )

Exclusion criteria

• Patients on ( steroids , antiemetics or any drug caude emesis )
• Any active cardiac condition at the time of the surgery
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups, including a placebo group

Dexmedetomidine 0.5 mic/kg bolus

Active Comparator group

Description:

selective alpha 2 adrenergic receptor agonist

Treatment:

Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

dexmedetomidine 0.75 mic/kg bllus

Active Comparator group

Description:

selective alpha 2 adrenergic receptor agonist

Treatment:

Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus

Placebo group

Placebo Comparator group

Description:

receving equal volume of normal saline

Treatment:

Drug: Placebo