Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

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

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

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

Conditions
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Postoperative Nausea and Vomiting, Head and Neck Surgeries

Intervention / Treatment
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* Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus
* Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus
* Drug: Placebo


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: comparative study between two doses and a 3rd control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine 0.5 mic/kg bolus<br>selective alpha 2 adrenergic receptor agonist | Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus<br>* comparison between two bolus doses of dexmedetomidine with a placebo group<br>|
| Active Comparator: dexmedetomidine 0.75 mic/kg bllus<br>selective alpha 2 adrenergic receptor agonist | Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus<br>* comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.<br>|
| Placebo Comparator: Placebo group<br>receving equal volume of normal saline | Drug: Placebo<br>* equal volume of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PONV in the 1st 24 hours postoperatively | The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries. | The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of PONV attacks | Number of PONV attacks in the 1st 24 hours following Head and neck surgeries | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 
| Pain score postoperatively. | Pain assessement using visual analogous scale score (0-10) with 10 denoting the worst pain expressed and zero= no pain | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 
| Sedation score | using Observer's assessment of ALERTNESS and Sedation (1-5)with 1 = unconscious and 5= Alert | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 
| Patient satisfaction | The patient completes a simple questionnaire with 0= very satisfied 1 = satisfied 2= not satisfied | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 
| Blood pressure | Mean arterial blood pressure (MAP) in the 1st 24 hours | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 
| Heart Rate (HR) | Pulse rate in the 1st 24 hours | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 
| The time to 1st call for rescue antiemetic | time to 1st call for rescue antiemetic and the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea | In the 1st 24 hours | 
| The severity of nausea. | the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 
| Total amount of morphine consumption | morphine consumed in thw 1st 24 hours in milligrams. | The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ) | 
| The time to 1st call for rescue analgesia | time to 1st call for rescure analgesic medication in the 1st 24 hours postoperatively | In the first 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, PONV, ondansetron, post operative, nausea, vomiting