Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2023-06-20

Brief Summary

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

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Detailed Description

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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

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Postoperative Nausea and Vomiting Head and Neck Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

comparative study between two doses and a 3rd control group

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Dexmedetomidine 0.5 mic/kg bolus

selective alpha 2 adrenergic receptor agonist

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

Intervention Type DRUG

comparison between two bolus doses of dexmedetomidine with a placebo group

dexmedetomidine 0.75 mic/kg bllus

selective alpha 2 adrenergic receptor agonist

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Hydrochloride 0.75 mic/kg bolus

Intervention Type DRUG

comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.

Placebo group

receving equal volume of normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

equal volume of normal saline

Interventions

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Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

comparison between two bolus doses of dexmedetomidine with a placebo group

Intervention Type DRUG

Dexmedetomidine Hydrochloride 0.75 mic/kg bolus

comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.

Intervention Type DRUG

Placebo

equal volume of normal saline

Intervention Type DRUG

Eligibility Criteria

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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 )